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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00002766
First received: November 1, 1999
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Biological: dactinomycin
Biological: sargramostim
Drug: carmustine
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: mercaptopurine
Drug: methotrexate
Drug: mitoxantrone hydrochloride
Drug: pegaspargase
Drug: prednisone
Drug: vincristine sulfate
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial Comparing ARA-C/High-Dose Mitoxantrone ("ALL-2') to A Standard Vincristine/Prednisone Based Regimen ('L-20') as Induction Therapy For Adult Patients With Acute Lymphoblastic Leukemia (ALL): The ALL-4 Protocol

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • complete remission (CR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to Complete remission [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: March 1996
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARA-C/High-Dose Mitoxantrone("All-2")
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
Active Comparator: Standard Vincristine/Prednisone ("L-20")
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002766

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1678
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305-5750
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Nicole Lamanna, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00002766     History of Changes
Other Study ID Numbers: 96-015, P30CA008748, MSKCC-96015A1, NCI-V96-0881
Study First Received: November 1, 1999
Last Updated: April 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Dactinomycin
Daunorubicin
Doxorubicin
Liposomal doxorubicin
Methotrexate
Mitoxantrone
Pegaspargase
Prednisone
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Analgesics
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on October 29, 2014