NCT00061945 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2022-05-03

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)

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outcome · POSTED

Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)

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outcome · POSTED

Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II)

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outcome · POSTED

Disease-free Survival, for Only Complete Response Patients

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outcome · POSTED

Overall Survival

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outcome · POSTED

Number of Participants Achieving Complete Remission

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 15 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
See detailed description.
intervention Names
Drug: allopurinol
Drug: cyclophosphamide
Drug: daunorubicin hydrochloride
Drug: vincristine sulfate
Drug: dexamethasone
Drug: asparaginase
Biological: filgrastim
Drug: imatinib mesylate
Drug: methotrexate
Drug: cytarabine
Drug: trimethoprim-sulfamethoxazole
Drug: mercaptopurine
label
Treatment (alemtuzumab and combination chemotherapy)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given PO
name
allopurinol
type
DRUG
arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given IV
name
cyclophosphamide
type
DRUG
arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given IV
name
daunorubicin hydrochloride
type
DRUG
arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given IV
name
vincristine sulfate
type
DRUG
arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given PO and as eye drops
name
dexamethasone
type
DRUG
arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given SC
name
asparaginase
type
DRUG
arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given SC
name
filgrastim
type
BIOLOGICAL
arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given PO
name
imatinib mesylate
type
DRUG
arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given IT, IV, and PO
name
methotrexate
type
DRUG
arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given IV
name
cytarabine
type
DRUG
arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given PO
name
trimethoprim-sulfamethoxazole
type
DRUG
arm Group Labels
Treatment (alemtuzumab and combination chemotherapy)
description
Given PO
name
mercaptopurine
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 302
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.
measure
Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)
time Frame
6 weeks
description
The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV.
measure
Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)
time Frame
8 months

secondary Outcomes

description
Minimal Residual Disease measures the presence of of circulating leukemia cells in the body. Patients that report a Complete Response (CR) during treatment are further tested to determine the presence of small amounts of circulating leukemia cells. Here we report the number of patients who were MRD negative.
measure
Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II)
time Frame
9 years 4 months
description
Disease Free Survival (DFS) is defined as the time from a Complete Response (CR) until death or relapse. The date of last clinical assesment will be used as the censor date for patients with no death or relapse. The DFS will be estimated using the Kaplan-Meier method with confidence intervals presented.
measure
Disease-free Survival, for Only Complete Response Patients
time Frame
9 years 4 months
description
Overall Survival is defines as the time from registration to death due to any cause. It is estimated using the Kaplan-Meier method with confidence intervals presented.
measure
Overall Survival
time Frame
9 years 4 months

Full study description

brief Summary: 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.
detailed Description: 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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice