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Clinical Trials/NCT00262925
NCT00262925TerminatedPhase 2

A Phase II Study of MOAD (Methotrexate, Vincristine, L-asparaginase and Dexamethasone) With Subcutaneous Campath for Adults With Relapsed or Refractory Acute Leukemia (ALL)

National Cancer Institute (NCI)58 sites in 1 country12 target enrollmentStarted: June 2006Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
12
Locations
58
Primary Endpoint
Complete Response Rate

Study Overview

Brief Summary

This phase II trial is studying how well giving combination chemotherapy together with alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. 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. Giving combination chemotherapy together with alemtuzumab may kill more cancer cells.

Detailed Description

OBJECTIVES:

I. Determine the complete response rate in patients with relapsed or refractory acute lymphoblastic leukemia treated with methotrexate, vincristine, asparaginase, and dexamethasone (MOAB) in combination with alemtuzumab.

II. Determine disease-free and/or overall survival of patients treated with this regimen.

III. Determine the toxic effects of this regimen in these patients.

IV. Correlate the density of cluster of differentiation 52 (CD52) molecules on the surface of leukemic lymphoblasts with response in patients treated with this regimen.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Refractory or relapsed acute lymphoblastic leukemia
  • Must be in first relapse or have failed to achieve complete remission with 1 prior regimen
  • Prior central nervous system (CNS) leukemia allowed provided cerebrospinal fluid is normal
  • ECOG Performance status of 0-3
  • Bilirubin normal
  • Creatinine normal
  • Human immunodeficiency virus (HIV) negative
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Exclusion criteria:
  • Hepatitis B positivity
  • Bacterial or fungal infection
  • Infection requiring treatment with antibiotics
  • Active cytomegalovirus infection by molecular detection methods
  • Known hypersensitivity to alemtuzumab or its components
  • Pregnant or nursing
  • Other malignancy within the past 5 years except adequately treated basal cell skin cancer or cervical carcinoma

Exclusion Criteria

  • Not provided

Arms & Interventions

Treatment (chemotherapy, enzyme inhibitor therapy)

Experimental

INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.

CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.

CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.

MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.

Intervention: alemtuzumab (Biological)

Treatment (chemotherapy, enzyme inhibitor therapy)

Experimental

INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.

CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.

CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.

MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.

Intervention: asparaginase (Drug)

Treatment (chemotherapy, enzyme inhibitor therapy)

Experimental

INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.

CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.

CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.

MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.

Intervention: methotrexate (Drug)

Treatment (chemotherapy, enzyme inhibitor therapy)

Experimental

INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.

CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.

CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.

MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.

Intervention: dexamethasone (Drug)

Treatment (chemotherapy, enzyme inhibitor therapy)

Experimental

INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.

CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.

CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.

MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.

Intervention: leucovorin calcium (Drug)

Treatment (chemotherapy, enzyme inhibitor therapy)

Experimental

INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.

CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.

CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.

MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.

Intervention: mercaptopurine (Drug)

Treatment (chemotherapy, enzyme inhibitor therapy)

Experimental

INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.

CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.

CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.

MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.

Intervention: vincristine (Drug)

Outcomes

Primary Outcomes

Complete Response Rate

Time Frame: assessed before the first consolidation cycle and first cytoreduction cycle, before the first and after the last maintenance cycle; after discontinuing treatment, assessed every 3 months if < 2 years and every 6 months if 2-5 years from study entry

Complete response requires that all of the following be present for at least four weeks. 1. Peripheral Blood Counts: Neutrophil count \>= 1.0 x 109/L, Platelet count \>= 100 x 109/L, Reduced hemoglobin concentration or hematocrit has no bearing on remission status, Leukemic blasts must not be present in the peripheral blood. 2 .Bone Marrow Aspirate and Biopsy: Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines, \<= 5% blasts. 3. Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.

Secondary Outcomes

  • Overall Survival(assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry)

Investigators

Sponsor Class
Nih
Responsible Party
Sponsor

Study Sites (58)

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