Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma

NCT00002766 | Completed Phase 3 Results

• 4 other identifiers: 96-015P30CA008748MSKCC-96015A1NCI-V96-0881
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia. PURPOSE: This randomized phase III trial is studying two different chemotherapy regimens and comparing them to see how well they work in treating adults with acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.

Conditions

Leukemia; Lymphoma

Keywords

blastic phase chronic myelogenous leukemia; untreated adult acute lymphoblastic leukemia; chronic myelogenous leukemia, BCR-ABL1 positive; T-cell adult acute lymphoblastic leukemia; B-cell adult acute lymphoblastic leukemia; stage I adult lymphoblastic lymphoma; stage II adult lymphoblastic lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; contiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II adult lymphoblastic lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Remission (CR)

  complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count \> 1,000 x 10\^6/1, a platelet count \> 100,000 x 10\^9/1, no circulating blasts, and \< than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia.

  2 years

Study Arms (2)

ARA-C/High-Dose Mitoxantrone("All-2")

EXPERIMENTAL

See detail description

Biological: dactinomycin; Biological: sargramostim; Drug: carmustine; Drug: cyclophosphamide; Drug: cytarabine; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: mercaptopurine; Drug: methotrexate; Drug: mitoxantrone hydrochloride; Drug: pegaspargase; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy

Standard Vincristine/Prednisone ("L-20")

ACTIVE COMPARATOR

See detail description

Biological: sargramostim; Drug: carmustine; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: doxorubicin hydrochloride; Drug: methotrexate; Drug: pegaspargase; Drug: prednisone; Drug: vincristine sulfate

Interventions

dactinomycin BIOLOGICAL

ARA-C/High-Dose Mitoxantrone("All-2")

sargramostim BIOLOGICAL

ARA-C/High-Dose Mitoxantrone("All-2"); Standard Vincristine/Prednisone ("L-20")

carmustine DRUG

ARA-C/High-Dose Mitoxantrone("All-2"); Standard Vincristine/Prednisone ("L-20")

cyclophosphamide DRUG

ARA-C/High-Dose Mitoxantrone("All-2"); Standard Vincristine/Prednisone ("L-20")

cytarabine DRUG

ARA-C/High-Dose Mitoxantrone("All-2"); Standard Vincristine/Prednisone ("L-20")

daunorubicin hydrochloride DRUG

Standard Vincristine/Prednisone ("L-20")

doxorubicin hydrochloride DRUG

ARA-C/High-Dose Mitoxantrone("All-2"); Standard Vincristine/Prednisone ("L-20")

etoposide DRUG

ARA-C/High-Dose Mitoxantrone("All-2")

mercaptopurine DRUG

ARA-C/High-Dose Mitoxantrone("All-2")

methotrexate DRUG

ARA-C/High-Dose Mitoxantrone("All-2"); Standard Vincristine/Prednisone ("L-20")

mitoxantrone hydrochloride DRUG

ARA-C/High-Dose Mitoxantrone("All-2")

pegaspargase DRUG

ARA-C/High-Dose Mitoxantrone("All-2"); Standard Vincristine/Prednisone ("L-20")

prednisone DRUG

ARA-C/High-Dose Mitoxantrone("All-2"); Standard Vincristine/Prednisone ("L-20")

vincristine sulfate DRUG

ARA-C/High-Dose Mitoxantrone("All-2"); Standard Vincristine/Prednisone ("L-20")

radiation therapy RADIATION

ARA-C/High-Dose Mitoxantrone("All-2")

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of one of the following malignancies: * Acute lymphoblastic leukemia (ALL) of B- or T-cell lineage * Philadelphia chromosome-positive ALL eligible * Lymphoblastic lymphoma * Chronic myelogenous leukemia in lymphoid blast crisis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 20-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.0 mg/dL * Glucocorticoids for higher bilirubin allowed prior to entry, at principal investigator's discretion Renal: * Creatinine no greater than 2.0 mg/dL * Glucocorticoids or renal radiotherapy for higher creatinine allowed prior to entry, at principal investigator's discretion Cardiovascular: * Left ventricular ejection fraction at least 50% Other: * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy Chemotherapy * No prior chemotherapy Endocrine therapy * No prior endocrine therapy Radiotherapy * No prior radiotherapy Surgery * No prior surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1678, United States

Location

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305-5750, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Blast Crisis; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Dactinomycin; sargramostim; Carmustine; Cyclophosphamide; Cytarabine; Daunorubicin; Doxorubicin; Etoposide; Mercaptopurine; Methotrexate; Mitoxantrone; pegaspargase; Prednisone; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Aminopterin; Pterins; Pteridines; Anthraquinones; Anthrones; Anthracenes; Quinones; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Therapeutics

Results Point of Contact

• Title: Dr. Peter Maslak
• Organization: Memorial Sloan Kettering Cancer Center

maslakp@mskcc.org

212-639-5518

Study Officials

• Nicole Lamanna, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: March 1, 1996
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 22, 2016
• Results First Posted: February 22, 2016

Record last verified: 2016-01

Locations

US (7)