Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia

NCT00671658 | Completed Phase 2 Results

• 1 other identifier: ID02-230
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma.

Conditions

Leukemia; Acute Lymphoblastic Leukemia

Keywords

Lymphoma; HYPER-CVAD; Leukemia; Acute Lymphoblastic Leukemia; ALL; Remission Duration; Chemotherapy; Asparaginase; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Leukine; Methotrexate; Rituximab; Vincristine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Response

  Response - Complete remission (CR): Normalization peripheral blood \& bone marrow 5% or \<blasts in normocellular or hypercellular marrow granulocyte count of 1x10\^9/L or \> \& platelet count \>100x10\^9/L; CR with incomplete platelet recovery (CRp): CR but platelet count \<100x10\^9/L. CR with incomplete recovery (CRi): CR but platelet count \<100x10\^9/L or absolute neutrophil count \< 1x10\^9/L. Partial response (PR): As above except for presence of 6-25% marrow blasts. Lymphoblastic lymphoma (\& ALL subtypes with extramedullary disease): CR - disappearance all known disease. PR - \>50% decrease in tumor size using sum of product, includes 50% volume decrease in lesions measurable in 3 dimensions. No Response (NR) - No significant change (includes stable disease). Lesions decreased size but \<50% or lesions with slight enlargement \<25% increase in size. Progressive Disease (PD): Appearance new lesions, 25% or \> increase in size existing lesions (\>50% if 1 lesion \& \<2).

  Response assessed following first 21 day course up to end of treatment with 8 cycles, up to 210 days

Study Arms (1)

HYPER-CVAD

EXPERIMENTAL

Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide (CTX) 300 mg/m\^2 IV, Doxorubicin 50 mg/m\^2 IV, Vincristine 2 mg IV, Dexamethasone 40 mg IV or oral (PO). Methotrexate (MTX) 12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 - 200 mg/m\^2 IV followed by 800 mg/m\^2 for Courses 2,4,6,8. Cytarabine 100 mg intrathecal for Courses 1,3,5,7 - 3 gm/m\^2 IV for Courses 2,4,6,8. G-CSF 10 ug/kg subcutaneous injection. Mesna 600 mg/m2 a day IV, Pegylated asparaginase 2000 International units/m\^2 IV. Pegfilgrastim 6 mg (flat dose) within 72 hrs after completion of chemotherapy. Solumedrol 40 mg IV for Courses 2,4,6,8.

Drug: Rituximab; Drug: Cyclophosphamide (CTX); Drug: Doxorubicin; Drug: Vincristine; Drug: Dexamethasone; Drug: Methotrexate (MTX); Drug: Cytarabine; Drug: G-CSF; Drug: Mesna; Drug: Pegylated asparaginase; Drug: Pegfilgrastim; Drug: Solumedrol

Interventions

Rituximab DRUG

375 mg/m2 by vein

Also known as: Rituxan

HYPER-CVAD

Cyclophosphamide (CTX) DRUG

300 mg/m2 by vein

Also known as: Cytoxan, Neosar

HYPER-CVAD

Doxorubicin DRUG

50 mg/m2 by vein

Also known as: Adriamycin, Rubex

HYPER-CVAD

Vincristine DRUG

2 mg by vein

Also known as: Oncovin, Vincasar Pfs

HYPER-CVAD

Dexamethasone DRUG

40 mg by vein or by mouth (P.O.)

Also known as: Decadron

HYPER-CVAD

Methotrexate (MTX) DRUG

12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 200 mg/m2 by vein followed by 800 mg/m2 for Courses 2,4,6,8

Also known as: Rheumatrex

HYPER-CVAD

Cytarabine DRUG

100 mg intrathecal for Courses 1,3,5,7 3 gm/m2 by vein for Courses 2,4,6,8

Also known as: Ara-C, Cytosar-U, Arabinosylcytosine, DepoCyt

HYPER-CVAD

G-CSF DRUG

10 ug/kg subcutaneous injection

Also known as: Filgrastim, Neupogen

HYPER-CVAD

Mesna DRUG

600 mg/m2 a day by vein

Also known as: Mesnex

HYPER-CVAD

Pegylated asparaginase DRUG

2000 International units/m2 by vein

Also known as: Pegaspargase, Oncaspar, Polyethylene Glycol Conjucated Lasparaginase-H

HYPER-CVAD

Pegfilgrastim DRUG

6 mg (flat dose) within 72 hrs after completion of chemotherapy

Also known as: Neulasta, PEG-G-CSF

HYPER-CVAD

Solumedrol DRUG

40 mg by vein for Courses 2,4,6,8

Also known as: Methylprednisolone, Depo-Medrol, Medrol

HYPER-CVAD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed, previously untreated Acute Lymphoblastic Leukemia (ALL) or lymphoblastic lymphoma, or having achieved Complete Remission (CR) with one course of induction chemotherapy.
• Failure to one induction course of chemotherapy are eligible, but these patients will be analyzed separately.
• All ages are eligible.
• Zubrod performance less than or equal to 3
• Adequate liver function (bilirubin \</= 3.0 mg/dl unless considered due to tumor) and renal function (creatinine \</= 3.0 mg/dl, unless considered due to tumor).
• Adequate cardiac function as assessed by history and physical examination.
• No active co-existing malignancy with life expectancy less than 12 months due to that malignancy.

You may not qualify if:

• \) N/A

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Official Website

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Dexamethasone; Calcium Dobesilate; Methotrexate; Cytarabine; Granulocyte Colony-Stimulating Factor; Filgrastim; Mesna; pegaspargase; pegfilgrastim; pegylated granulocyte colony-stimulating factor, human; Methylprednisolone Hemisuccinate; Methylprednisolone; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Aminopterin; Pterins; Pteridines; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Prednisolone

Results Point of Contact

• Title: Hagop Kantarjian, MD./ Chair
• Organization: The University of Texas (UT) MD Anderson Cancer Center

eharriso@mdanderson.org

713-792-7026

Study Officials

• Susan O'Brien, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 5, 2008
• Study Start: November 1, 2002
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 3, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-12

Locations

US (1)