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Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Cancer and Leukemia Group B.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00003700
First received: November 1, 1999
Last updated: April 10, 2012
Last verified: April 2011
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have untreated acute lymphoblastic leukemia.


Condition Intervention Phase
Leukemia
Biological: G-CSF
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: vincristine sulfate
Drug: Allopurinol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Increased Doses of Daunorubicin During Induction, and Cytarabine During Consolidation, Followed by High-Dose Methotrexate and Intrathecal Methotrexate in Place of Cranial Irradiation

Resource links provided by NLM:


Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Complete Response [ Time Frame: 6 months post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: prior to ea tx and ea maintenance course ] [ Designated as safety issue: Yes ]
  • CNS relapse rate [ Time Frame: before ea tx, q 3 mon for 1 yr, q 6 mon for 2 yrs, then yrly up to 10 yrs ] [ Designated as safety issue: No ]

Enrollment: 163
Study Start Date: January 1999
Estimated Study Completion Date: January 2013
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daunorubicin, ara-C, & MTX Therapy
daunorubicin during induction, increasing doses of cytarabine during consolidation followed by methotrexate in place of cranial irradiation for treatment of ALL
Biological: G-CSF
Courses I, II, IV, V: 5 ug/kg/d subQ injection Day 4 until ANC > 5,000 uL after nadir: 7 day minimum for Courses I & IV
Other Name: filgrastim
Drug: asparaginase
6000 U/sq m subQ or IM injection 2X/wk for 6 doses starting on Day 5: Courses I & IV
Drug: cyclophosphamide
1200 mg/sq m IV infusion over 15-30 min Day 1 Courses I & IV (pts < 60y/o) 1000 mg/sq m IV infusion over 15-30 min Day 1 Courses II & V
Drug: cytarabine
2000 mg/sq m IV infusion over 3 hrs Days 1,2, & 3: Courses II & V
Other Name: ara-C
Drug: daunorubicin hydrochloride
80mg/sq m (pts<60y/o)OR 60mg/sq m (pts =/>60y/o) IV infusion over 5-10 min Days 1,2,& 3: Courses I & IV
Drug: leucovorin calcium

Courses III & VI:

25mg/sq m IV infusion Days 2, 9, and 16 5mg/sq m PO q 6 hr for 8 doses or until serum MTX <0.05 uM after ea IV dose

Drug: mercaptopurine
60mg/sq m/d PO every day Course VII
Drug: methotrexate
15mg intrathecal Day 1 Courses II & V 1000mg/sq m IV infusion over 3 hrs Days 1, 8, & 15 and 25mg/sq m PO q 6hr x 4 doses after ea IV dose: Courses III & VI.
Drug: prednisone
60mg/sq m/day PO Days 1-21 (pts<60y/o) OR Days 1-7 (pts >/= 60y/o) Courses I & IV and Days 1-5 of ea 4 cycle in Course VII
Drug: vincristine sulfate
2 mg total IV infusion Days 1,8,15,& 22 Courses I & IV and Days 1, 8, & 15 Courses III & VI, and Day 1 of ea 4 wk cycle in Course VII
Drug: Allopurinol
300mg PO q day Days 1-14 Course I

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven acute lymphoblastic leukemia (FAB L1 or L2) or acute undifferentiated leukemia
  • Must be registered on companion protocol CALGB-9862

PATIENT CHARACTERISTICS:

Age

  • 15 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior emergency leukapheresis allowed
  • No other prior biologic therapy for leukemia

Chemotherapy

  • Prior emergency treatment with hydroxyurea for hyperleukocytosis allowed
  • No other prior chemotherapy for leukemia
  • No other concurrent chemotherapy

Endocrine therapy

  • No prior endocrine therapy for leukemia
  • No concurrent hormonal therapy (except steroids for adrenal failure or hormones for nondisease related conditions)

Radiotherapy

  • One prior dose of cranial radiotherapy for CNS leukostasis allowed
  • No other prior radiotherapy for leukemia
  • No concurrent palliative radiotherapy except whole brain irradiation for CNS disease

Surgery

  • Not specified
  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: NCT00003700

  Show 50 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Wendy Stock, MD University of Chicago
  More Information

Additional Information:
Publications:
Stock W, Yu D, Johnson J, et al.: Intensified Daunorubicin during induction and post-remission therapy of adult acute lymphoblastic leukemia (ALL): results of CALGB 19802. [Abstract] Blood 102 (11 Pt 1): A-1375, 2003.
Stock W, Dodge RK, Vardiman JW, et al.: Treatment of adult acute lymphoblastic leukemia (ALL): phase II trial of dose intensification of Daunorubicin and Cytarabine followed by high-dose Methotrexate and intrathecal Methotrexate in place of cranial irradiation (CALGB 19802). [Abstract] Blood 98 (11 Pt 1): A-2472, 2001.

Responsible Party: Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00003700     History of Changes
Other Study ID Numbers: CDR0000066807, U10CA031946, CLB-19802
Study First Received: November 1, 1999
Last Updated: April 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:
untreated adult acute lymphoblastic leukemia
L1 adult acute lymphoblastic leukemia
L2 adult acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Levoleucovorin
Methotrexate
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Antiviral Agents

ClinicalTrials.gov processed this record on November 24, 2014