Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002766

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: CHOP regimen 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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Radiation Therapy

Drug Information available for: Cyclophosphamide 6-Mercaptopurine Dactinomycin Prednisone Vincristine Methotrexate Cytarabine hydrochloride Daunorubicin Doxorubicin Daunorubicin hydrochloride Doxorubicin hydrochloride Etoposide Mitoxantrone Mitoxantrone hydrochloride Myocet Sargramostim Pegaspargase Cytarabine Carmustine Vincristine sulfate Mercaptopurine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	154
Study Start Date:	March 1996

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

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:

Mark Adam Weiss, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000064730, MSKCC-96015A1, NCI-V96-0881
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002766 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

blastic phase chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
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

Study placed in the following topic categories:

Philadelphia Chromosome
Anti-Inflammatory Agents
Prednisone
Blast Crisis
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
6-Mercaptopurine
Hormones
Pegaspargase
Dactinomycin
Methotrexate
Etoposide
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal

Carmustine
Vincristine
Leukemia, Myeloid
Glucocorticoids
Doxorubicin
Folic Acid
Chronic Myelogenous Leukemia
Mitoxantrone
Antineoplastic Agents, Phytogenic
Antimetabolites
Daunorubicin
Leukemia, Lymphoid
Immunologic Factors
Folate
Cyclophosphamide

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
6-Mercaptopurine
Hormones
Pegaspargase
Dactinomycin
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents

Nucleic Acid Synthesis Inhibitors
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Carmustine
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Neoplasms
Mitoxantrone
Antineoplastic Agents, Phytogenic
Antimetabolites
Daunorubicin

ClinicalTrials.gov processed this record on July 02, 2009