Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2012-10-31

Brief Summary

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This phase I/II trial studies the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy also work in different ways to kill cancer cells or stop them from growing. Giving alemtuzumab together with combination chemotherapy may be a better way to block cancer growth.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To determine the feasibility and toxicity profiles of escalating doses of Campath-1H (alemtuzumab) given subcutaneously during post-remission intensification treatment of adults with acute lymphoblastic leukemia (ALL).

II. To determine the disease-free survival (DFS) and overall survival (OS) when Campath-1H is used during post-remission intensification treatment of adults with ALL.

III. To determine whether antibody treatment with Campath-1H can further reduce minimal residual disease states in adult ALL.

IV. To obtain preliminary descriptive data on serum levels of Campath-1H during course IV, module D using limited pharmacokinetic sampling during the phase I and II components of the study.

V. To obtain feasibility data on the addition of imatinib to Cancer and Leukemia Group B (CALGB) induction and postremission combination chemotherapy for patients with Philadelphia chromosome positive (Ph+) ALL.

OUTLINE: This is a dose-escalation study of alemtuzumab.

COURSE 1 (module A): Patients receive allopurinol orally (PO) 4 times daily (QID) on days 1-14, cyclophosphamide\* intravenously (IV) over 15-30 minutes on day 1, daunorubicin hydrochloride IV on days 1-3, vincristine sulfate IV on days 1, 8, 15, and 22, dexamethasone PO twice daily (BID) on days 1-7 and 15-21, asparaginase subcutaneously (SC) on days 5, 8, 11, 15, 18, and 22, and filgrastim SC on days 4-11. Patients who are Ph+ also receive imatinib mesylate PO on days 15-28.

\*Note: Patients who are = 60 years old do not receive cyclophosphamide.

COURSE 2 (module B): Patients receive methotrexate intrathecally (IT) on day 1, cytarabine IV over 3 hours on days 1-3, dexamethasone as eye drops QID on days 1-4, trimethoprim-sulfamethoxazole PO BID 3 times weekly on days 1-29, and cyclophosphamide, asparaginase and filgrastim as in course 1. Patients who are Ph+ also receive imatinib mesylate PO on days 1-28.

COURSE 3 (module C): Patients receive vincristine sulfate IV on days 1, 15, and 29, methotrexate IV over 3 hours and IT on days 1, 15, and 19, methotrexate PO every 6 hours on days 1-2, 15-16, and 29-30, mercaptopurine PO on days 1-35, leucovorin calcium IV on days 2, 16, and 30, leucovorin calcium PO every 6 hours on days 3-4, and trimethoprim-sulfamethoxazole PO BID 3 times weekly on days 1-43. Patients who are Ph+ also receive imatinib mesylate PO on days 1-42.

COURSE 4 (module D): Patients receive alemtuzumab SC 3 times weekly for 4 weeks and begin acyclovir PO QID for 6 months (continuing through course 8).

* Phase I Cohort 1: 10 mg
* Phase I Cohort 2: 20 mg
* Phase I Cohort 3/Phase II MTD: 30 mg

COURSE 5 (module A): Patients repeat course 1, minus allopurinol.

COURSE 6 (module B): Patients repeat course 2.

COURSE 7 (module C): Patients repeat course 3.

COURSE 8: Patients receive mercaptopurine PO, vincristine sulfate IV on day 1, dexamethasone PO on days 1-5, methotrexate PO on days 1, 8, 15, and 22, and trimethoprim-sulfamethoxazole PO BID 3 days weekly. Patients who are Ph+ also receive imatinib mesylate PO on days 1-28. Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 10 years.

Conditions

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Acute Undifferentiated Leukemia B-cell Adult Acute Lymphoblastic Leukemia B-cell Childhood Acute Lymphoblastic Leukemia L1 Adult Acute Lymphoblastic Leukemia L1 Childhood Acute Lymphoblastic Leukemia L2 Adult Acute Lymphoblastic Leukemia L2 Childhood Acute Lymphoblastic Leukemia Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia T-cell Adult Acute Lymphoblastic Leukemia T-cell Childhood Acute Lymphoblastic Leukemia Untreated Adult Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (alemtuzumab and combination chemotherapy)

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Group Type EXPERIMENTAL

allopurinol

Intervention Type DRUG

Given PO

cyclophosphamide

Intervention Type DRUG

Given IV

daunorubicin hydrochloride

Intervention Type DRUG

Given IV

vincristine sulfate

Intervention Type DRUG

Given IV

dexamethasone

Intervention Type DRUG

Given PO and as eye drops

asparaginase

Intervention Type DRUG

Given SC

filgrastim

Intervention Type BIOLOGICAL

Given SC

imatinib mesylate

Intervention Type DRUG

Given PO

methotrexate

Intervention Type DRUG

Given IT, IV, and PO

cytarabine

Intervention Type DRUG

Given IV

trimethoprim-sulfamethoxazole

Intervention Type DRUG

Given PO

mercaptopurine

Intervention Type DRUG

Given PO

leucovorin calcium

Intervention Type DRUG

Given IV and PO

alemtuzumab

Intervention Type BIOLOGICAL

Given SC

acyclovir

Intervention Type DRUG

Given PO

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

pharmacological study

Intervention Type OTHER

Correlative studies

Interventions

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allopurinol

Given PO

Intervention Type DRUG

cyclophosphamide

Given IV

Intervention Type DRUG

daunorubicin hydrochloride

Given IV

Intervention Type DRUG

vincristine sulfate

Given IV

Intervention Type DRUG

dexamethasone

Given PO and as eye drops

Intervention Type DRUG

asparaginase

Given SC

Intervention Type DRUG

filgrastim

Given SC

Intervention Type BIOLOGICAL

imatinib mesylate

Given PO

Intervention Type DRUG

methotrexate

Given IT, IV, and PO

Intervention Type DRUG

cytarabine

Given IV

Intervention Type DRUG

trimethoprim-sulfamethoxazole

Given PO

Intervention Type DRUG

mercaptopurine

Given PO

Intervention Type DRUG

leucovorin calcium

Given IV and PO

Intervention Type DRUG

alemtuzumab

Given SC

Intervention Type BIOLOGICAL

acyclovir

Given PO

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

pharmacological study

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Unequivocal histologic diagnosis of precursor B or precursor T lymphoblastic leukemia (World Health Organization \[WHO\] classification), L1 or L2 ALL or acute undifferentiated leukemia (AUL) (French-American-British Cooperative group \[FAB\] Classification); Burkitt-type ALL (FAB L3, surface immunoglobulin \[SIg\]+) are excluded
* No prior treatment for leukemia with three permissible exceptions:

* Emergency leukapheresis II. Emergency treatment for hyperleukocytosis with hydroxyurea III. Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
* All patients must have a pre-treatment bone marrow or peripheral blood sample submitted for central immunophenotyping; only those patients who express CD52 \>= 10% in the leukemia blast cell channel will be eligible to receive Campath-1H during module D, course IV

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No