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
Recruitment status was Active, not recruiting
Sponsor:
Cancer and Leukemia Group B
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
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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:
Drug Information available for:
Cyclophosphamide
Mercaptopurine
Prednisone
Methotrexate
Cytarabine
Allopurinol
Leucovorin calcium
Vincristine sulfate
Asparaginase
Methotrexate sodium
Allopurinol sodium
Daunorubicin
Daunorubicin hydrochloride
Levoleucovorin
Filgrastim
Granulocyte colony-stimulating factor
Daunorubicin citrate
U.S. FDA Resources
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003700
Show 50 Study Locations
Show 50 Study LocationsSponsors 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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Allopurinol Cytarabine Methotrexate Cyclophosphamide Asparaginase |
Daunorubicin Prednisone Vincristine Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013