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

This study is currently recruiting patients.

Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
Philadelphia chromosome positive chronic myelogenous leukemia
adult acute lymphoblastic leukemia
adult lymphoblastic lymphoma
blastic phase chronic myelogenous leukemia
 Drug: carmustine
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: dactinomycin
 Drug: daunorubicin
 Drug: doxorubicin
 Drug: etoposide
 Drug: mercaptopurine
 Drug: methotrexate
 Drug: mitoxantrone
 Drug: pegaspargase
 Drug: prednisone
 Drug: sargramostim
 Drug: vincristine
 Procedure: chemotherapy
 Procedure: high-dose chemotherapy
 Procedure: radiation therapy
Phase III

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Induction With the ALL-2 Regimen (Cytarabine and High-Dose Mitoxantrone Based) Versus the L-20 Regimen (Vincristine and Prednisone Based) in Adults With Acute Lymphoblastic Malignancy: The ALL-4 Protocol

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating institution and antecedent lymphoid blast crisis of chronic myelogenous leukemia (yes vs no). Patients are randomized to one of two treatment arms.

Arm I:

Arm II:

  • Patients receive induction therapy consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times daily on days 1-29, cyclophosphamide IV on day 5, doxorubicin IV on days 23-25 and 42, methotrexate intrathecally on days 3, 5, 13, 16, 32, and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover.
  • At approximately 3 weeks following induction therapy, patients receive consolidation therapy consisting of cytarabine IV bolus on day 1 followed by continuous infusion cytarabine on days 1-5, with daunorubicin IV on days 1-3 and methotrexate intrathecally on days 2 and 4. Patients receive GM-CSF subcutaneously beginning on day 7 and continuing until blood counts recover.
  • At 6-8 weeks following the first course of consolidation therapy, patients receive a second consolidation course consisting of cytarabine IV bolus on day 1 followed by continuous infusion cytarabine on days 1-4 with methotrexate IV on days 1-4 and methotrexate intrathecally on days 2 and 4. Patients receive GM-CSF subcutaneously beginning on day 6 and continuing until blood counts recover.
  • At 6-8 weeks following the second course of consolidation therapy, patients receive a third consolidation course consisting of pegaspargase IV or IM on day 1.
  • At 3-4 weeks following the third course of consolidation therapy, patients receive a fourth consolidation course consisting of cyclophosphamide IV on day 1.
  • At 3 weeks following the completion of consolidation therapy, patients receive the same maintenance regimen as in Arm I. Treatment continues in patients achieving complete response. Patients in both arms receive alternating sequences of maintenance therapy over 2 years.

PROJECTED ACCRUAL: A total of 154 patients will be accrued for this study within approximately 6 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Location and Contact Information


California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1678,  United States; Recruiting
Gary John Schiller, MD  310-825-5513    garyjs@ucla.edu 

      Stanford Cancer Center at Stanford University Medical Center, Stanford,  California,  94305-5750,  United States; Recruiting
Steven E. Coutre, MD  650-723-5007    coutre@stanford.edu 

Georgia
      Winship Cancer Institute of Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
Leonard Thompson Heffner, MD  404-778-4348 

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Mark Adam Weiss, MD  212-639-5827 

      New York Medical College, Valhalla,  New York,  10595,  United States; Recruiting
Karen Seiter, MD  914-493-7514    karen_seiter@nymc.edu 

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
Joseph O. Moore, MD  919-684-3377    moore035@mc.duke.edu 

Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting
Matt E. Kalaycio, MD  216-444-3705    kalaycm@ccf.org 

Study chairs or principal investigators

Mark Adam Weiss, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000064730; MSKCC-96015A1; NCI-V96-0881; NCT00002766
Record last reviewed:  September 2003
Last Updated:  April 4, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002766
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005