Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00003700

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 II

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:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Cyclophosphamide 6-Mercaptopurine Prednisone Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Allopurinol sodium Daunorubicin Daunorubicin hydrochloride Citrovorum factor Filgrastim Granulocyte colony-stimulating factor Cytarabine Allopurinol Leucovorin Calcium Vincristine sulfate Folinic acid calcium salt pentahydrate Mercaptopurine L-Asparaginase

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 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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003700

Show 50 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Wendy Stock, MD

University of Chicago

More Information

Additional Information:

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

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:	Monica M Bertagnolli, 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 1, 2011
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 February 12, 2012