Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

NCT00873093 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2011-01908AALL07P1U10CA180886U10CA098543
• Study Type: interventional
• Target: 148
• Locations: 4 countries
• Sites: 171

Brief Summary

This pilot, phase II trial studies the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.

Conditions

B-cell Adult Acute Lymphoblastic Leukemia; B-cell Childhood Acute Lymphoblastic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Lymphoblastic Lymphoma; T-cell Adult Acute Lymphoblastic Leukemia; T-cell Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (4)

• Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy

  The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.

  The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.

• Event Free Survival

  Percentage of patients who were event free at 4 months

  4 months after enrollment

• Toxic Death Rate

  The proportion of toxic death rate among all eligible patients.

  4 months

• Severe Adverse Events (SAE) Rate.

  The proportion of SAE rate among all eligible patients

  4 months

Secondary Outcomes (3)

• Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1

  End of Block 1 (Day 36 of Block 1) of re-induction therapy

• Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2

  End of Block 2 (Day 36 of Block 2) of re-induction therapy

• Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3

  End of Block 3 (Day 36 of Block 3) of re-induction therapy

Other Outcomes (5)

• NF-kB Activity

  Up to 5 years

• Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots

  Up to 5 years

• Change in Stem Cell Percentage

  Baseline to post-treatment with bortezomib

Study Arms (5)

Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs

EXPERIMENTAL

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.

Drug: L-asparaginase; Drug: doxorubicin hydrochloride; Drug: therapeutic hydrocortisone; Drug: vincristine sulfate; Drug: cytarabine; Drug: prednisone; Drug: bortezomib; Drug: pegaspargase; Drug: methotrexate; Drug: etoposide phosphate; Drug: cyclophosphamide; Biological: filgrastim; Drug: leucovorin calcium; Other: laboratory biomarker analysis; Drug: High Dose MTX

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr

EXPERIMENTAL

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.

Drug: L-asparaginase; Drug: doxorubicin hydrochloride; Drug: therapeutic hydrocortisone; Drug: vincristine sulfate; Drug: cytarabine; Drug: prednisone; Drug: bortezomib; Drug: pegaspargase; Drug: methotrexate; Drug: etoposide phosphate; Drug: cyclophosphamide; Biological: filgrastim; Drug: leucovorin calcium; Other: laboratory biomarker analysis; Drug: High Dose MTX

Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs

EXPERIMENTAL

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.

Drug: L-asparaginase; Drug: doxorubicin hydrochloride; Drug: therapeutic hydrocortisone; Drug: vincristine sulfate; Drug: cytarabine; Drug: prednisone; Drug: bortezomib; Drug: pegaspargase; Drug: methotrexate; Drug: etoposide phosphate; Drug: cyclophosphamide; Biological: filgrastim; Drug: leucovorin calcium; Other: laboratory biomarker analysis; Drug: High Dose MTX

T-cell ALL (Chemotherapy)

EXPERIMENTAL

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.

Drug: L-asparaginase; Drug: doxorubicin hydrochloride; Drug: therapeutic hydrocortisone; Drug: vincristine sulfate; Drug: cytarabine; Drug: prednisone; Drug: bortezomib; Drug: pegaspargase; Drug: methotrexate; Drug: etoposide phosphate; Drug: cyclophosphamide; Biological: filgrastim; Drug: leucovorin calcium; Other: laboratory biomarker analysis; Drug: High Dose MTX

T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

EXPERIMENTAL

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.

Drug: L-asparaginase; Drug: doxorubicin hydrochloride; Drug: therapeutic hydrocortisone; Drug: vincristine sulfate; Drug: cytarabine; Drug: prednisone; Drug: bortezomib; Drug: pegaspargase; Drug: methotrexate; Drug: etoposide phosphate; Drug: cyclophosphamide; Biological: filgrastim; Drug: leucovorin calcium; Other: laboratory biomarker analysis; Drug: High Dose MTX

Interventions

L-asparaginase DRUG

Given IM 6000 IU/m2/dose Days 2 and 9

Also known as: ASNase, Colaspase, Crasnitin, Elspar, L-ASP

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

doxorubicin hydrochloride DRUG

Given IV 60 mg/m2/dose on Day 1

Also known as: ADM, ADR, Adria

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

therapeutic hydrocortisone DRUG

Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22

Also known as: Aeroseb-HC, Barseb HC, Cetacort, Cort-Dome, Cortef

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

vincristine sulfate DRUG

Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22

Also known as: liposomal vincristine, Marqibo, vincristine liposomal, vincristine sulfate liposome injection

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

cytarabine DRUG

Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9

Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

prednisone DRUG

Given PO or IV 40 mg/m2/day on Days 1-28

Also known as: DeCortin, Deltra

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

bortezomib DRUG

Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8

Also known as: LDP 341, MLN341, VELCADE

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

pegaspargase DRUG

Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22

Also known as: L-asparaginase with polyethylene glycol, Oncaspar, PEG-ASP, PEG-L-asparaginase

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

methotrexate DRUG

Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22

Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

etoposide phosphate DRUG

Given IV 100 mg/m2/dose on Days 1-5

Also known as: ETOP, Etopophos

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

cyclophosphamide DRUG

Given IV 440 mg/m2/dose on Days 1-5

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

filgrastim BIOLOGICAL

Given IV or SC 5 micrograms/kg/dose Only on Day 6

Also known as: G-CSF, Neupogen

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

leucovorin calcium DRUG

Given PO or IV 15mg/m2/dose q6h x 3 doses

Also known as: CF, CFR, LV

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

High Dose MTX DRUG

IV 5000 mg/m2/dose Block 2: Day 22

Also known as: methotrexate, amethopterin, Folex, methylaminopterin, Mexate

Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr; Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs; Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs; T-cell ALL (Chemotherapy); T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

Eligibility Criteria

• Age: 1 Year - 31 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis
• Pre-B ALL in first early (\< 36 months from diagnosis) isolated bone marrow (BM) or combined BM/extramedullary relapse; or
• T-cell ALL in first isolated BM or combined relapse; or
• T-LL in first relapse
• Patients with leukemia must have had histologic verification of the malignancy at relapse, including immunophenotyping to confirm diagnosis
• Patients with lymphoblastic lymphoma must have measurable disease documented by clinical, radiographic, or histologic criteria; patients must have relapsed or become refractory to conventional therapy
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
• Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study
• Patients who relapse on therapy other than standard ALL maintenance therapy must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• At least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, which is permitted up to 24 hours prior to the start of protocol therapy
• At least 7 days since the completion of therapy with a biologic agent or donor lymphocyte infusions (DLI); for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
• No evidence of active graft-vs-host disease (GVHD) and \>= 4 months must have elapsed; must not be receiving GVHD prophylaxis
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
• month to \< 6 months (0.4 male, 0.4 female)
• months to \< 1 year (0.5 male, 0.5 female)

You may not qualify if:

• Patients with Philadelphia chromosome positive ALL are not eligible unless refractory to at least one tyrosine kinase inhibitor (TKI) therapy; patients that are unable to tolerate TKI therapy due to toxicity are eligible
• Patients with mature B-cell ALL, ie, leukemia with B-cell (soluble immunoglobulin \[sIg\] positive and kappa or lambda restricted positivity) ALL, with French-American-British (FAB) L3 morphology and/or a myc translocation, are not eligible
• Extramedullary disease status: patients with isolated CNS disease or isolated testicular disease are not eligible
• Patients with known optic nerve and/or retinal involvement are not eligible; patients presenting with visual disturbances should have an ophthalmological exam and, if indicated, an magnetic resonance imaging (MRI) to determine optic nerve or retinal involvement
• Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible
• Cumulative prior anthracycline exposure must not exceed 400 mg/m\^2
• Patients taking anticonvulsants known to activate the cytochrome p450 system, in particular anticonvulsants such as phenytoin, carbamazepine, and phenobarbital, are not eligible; benzodiazepines and gabapentin are acceptable
• Patients who have previously received bortezomib or other proteasome inhibitors are not eligible
• Patients who have a known allergy to doxorubicin, cytarabine, both etoposide and etopophos, boron, mannitol or bortezomib are not eligible
• Patients who cannot receive any asparaginase products (E. Coli, PEG-asparaginase, or Erwinia asparaginase) on this study (eg, due to prior severe pancreatitis, stroke or other toxicity) are not eligible; patients who initially receive asparaginase, but must discontinue due to toxicity, remain eligible; patients with clinically significant prior allergies to pegaspargase are eligible if Erwinia L-asparaginase can be substituted
• Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective birth control method
• Patients must not have received any prior re-induction attempts and must not have received treatment for prior extramedullary relapse; patients with primary induction failure are not eligible

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (171)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

Location

Southern California Permanente Medical Group

Downey, California, 90242, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Miller Children's Hospital

Long Beach, California, 90806, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Children's Hospital Central California

Madera, California, 93636-8762, United States

Location

Children's Hospital and Research Center at Oakland

Oakland, California, 94609-1809, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Childrens Hospital of Orange County

Orange, California, 92868-3874, United States

Location

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States

Location

University of California at Davis Cancer Center

Sacramento, California, 95817, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

University of California San Francisco Medical Center-Parnassus

San Francisco, California, 94143, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

Memorial Healthcare System - Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Nemours Children's Clinic-Jacksonville South

Jacksonville, Florida, 32207, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

UF Cancer Center at Orlando Health

Orlando, Florida, 32806, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Saint Joseph Children's Hospital of Tampa

Tampa, Florida, 33607, United States

Location

Saint Mary's Hospital

West Palm Beach, Florida, 33407, United States

Location

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322, United States

Location

Memorial University Medical Center

Savannah, Georgia, 31404, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Southern Illinois University

Springfield, Illinois, 62702, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Saint Vincent Hospital and Health Services

Indianapolis, Indiana, 46260, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Floating Hospital for Children at Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Michigan State University Clinical Center

East Lansing, Michigan, 48824-7016, United States

Location

Hurley Medical Center

Flint, Michigan, 48502, United States

Location

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Kalamazoo Center for Medical Studies

Kalamazoo, Michigan, 49008, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Columbia Regional

Columbia, Missouri, 65201, United States

Location

The Childrens Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Saint John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, 89106, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

UMDNJ - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

Location

Overlook Hospital

Summit, New Jersey, 07902, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467-2490, United States

Location

Mission Hospital-Memorial Campus

Asheville, North Carolina, 28801, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Medical Center-Fargo

Fargo, North Dakota, 58122, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

The Toledo Hospital/Toledo Children's Hospital

Toledo, Ohio, 43606, United States

Location

Mercy Children's Hospital

Toledo, Ohio, 43608, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, 74136, United States

Location

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

Location

Legacy Emanuel Hospital and Health Center

Portland, Oregon, 97227, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Palmetto Health Richland

Columbia, South Carolina, 29203, United States

Location

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States

Location

Greenville Cancer Treatment Center

Greenville, South Carolina, 29605, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

T C Thompson Children's Hospital

Chattanooga, Tennessee, 37403, United States

Location

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Texas Tech University Health Science Center-Amarillo

Amarillo, Texas, 79106, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Childrens Hospital-King's Daughters

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Carilion Clinic Children's Hospital

Roanoke, Virginia, 24014, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

Location

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

West Virginia University Charleston

Charleston, West Virginia, 25304, United States

Location

Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6008, Australia

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Janeway Child Health Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Chedoke-McMaster Hospitals

Hamilton, Ontario, L8S 4L8, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

Children's Hospital

London, Ontario, N6A 5W9, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3, Canada

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

San Jorge Children's Hospital

San Juan, 00912, Puerto Rico

Location

Related Publications (2)

• Horton TM, Whitlock JA, Lu X, O'Brien MM, Borowitz MJ, Devidas M, Raetz EA, Brown PA, Carroll WL, Hunger SP. Bortezomib reinduction chemotherapy in high-risk ALL in first relapse: a report from the Children's Oncology Group. Br J Haematol. 2019 Jul;186(2):274-285. doi: 10.1111/bjh.15919. Epub 2019 Apr 7.

  PMID: 30957229 DERIVED

• Hanley MJ, Mould DR, Taylor TJ, Gupta N, Suryanarayan K, Neuwirth R, Esseltine DL, Horton TM, Aplenc R, Alonzo TA, Lu X, Milton A, Venkatakrishnan K. Population Pharmacokinetic Analysis of Bortezomib in Pediatric Leukemia Patients: Model-Based Support for Body Surface Area-Based Dosing Over the 2- to 16-Year Age Range. J Clin Pharmacol. 2017 Sep;57(9):1183-1193. doi: 10.1002/jcph.906. Epub 2017 Apr 18.

  PMID: 28419486 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Asparaginase; palmitoyl-L-asparaginase; Doxorubicin; Hydrocortisone; Vincristine; Cytarabine; Prednisone; Bortezomib; pegaspargase; Methotrexate; merphos; etoposide phosphate; Cyclophosphamide; Filgrastim; Granulocyte Colony-Stimulating Factor; Leucovorin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienediols; Pregnadienes; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Aminopterin; Pterins; Pteridines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

resultsreportingcoordinator@childrensoncologygroup.org

626-447-0064

Study Officials

• Terzah Horton, MD PhD

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 27, 2017
• Results First Posted: January 27, 2017

Record last verified: 2016-11

Locations

AU (1); US (157); PR (1); CA (12)