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Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Last Updated: 2015-05-05

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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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.

V. Correlate the presence of minimal residual disease at the time of maximal response to this regimen with overall outcome in these patients.

OUTLINE: This is a multicenter study. The study had two steps. Step 1: 5 mg dose of Campath (alemtuzumab); Step 2: 10 mg dose of Campath.

INDUCTION THERAPY: Patients receive methotrexate intravenously (IV) on day 1; vincristine IV and asparaginase intramuscularly (IM) on day 2; oral dexamethasone on days 1-10; and alemtuzumab subcutaneously (SC) on days 1, 4, and 7. Treatment repeats every 10 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) proceed to consolidation therapy.

CONSOLIDATION THERAPY: Patients receive methotrexate IV on day 1 and asparaginase IM on day 2. Treatment repeats every 10 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who remain in CR proceed to cytoreduction therapy.

CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV over 6 hours on day 1; leucovorin calcium IV continuously over 24 hours on days 1 and 2 and then orally 4 times a day on day 3; and oral dexamethasone on days 2-6. Treatment repeats every 30 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients who remain in CR proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive oral mercaptopurine on days 1-30; oral methotrexate on days 1, 8, 15, and 22; vincristine IV on day 1; and oral dexamethasone on days 1-5. Treatment repeats every 30 days for 36 courses in the absence of disease progression or unacceptable toxicity.

Patients are 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.

PROJECTED ACCRUAL: Allowing for two dose levels, a maximum of 48 patients may be accrued approximately in 30 months.

Conditions

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Recurrent Adult Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (chemotherapy, enzyme inhibitor therapy)

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.

Group Type EXPERIMENTAL

alemtuzumab

Intervention Type BIOLOGICAL

Given subcutaneously

asparaginase

Intervention Type DRUG

Given IM

methotrexate

Intervention Type DRUG

Given IV or orally

dexamethasone

Intervention Type DRUG

Given orally

leucovorin calcium

Intervention Type DRUG

Given IV

mercaptopurine

Intervention Type DRUG

Given orally

vincristine

Intervention Type DRUG

Given IV

Interventions

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alemtuzumab

Given subcutaneously

Intervention Type BIOLOGICAL

asparaginase

Given IM

Intervention Type DRUG

methotrexate

Given IV or orally

Intervention Type DRUG

dexamethasone

Given orally

Intervention Type DRUG

leucovorin calcium

Given IV

Intervention Type DRUG

mercaptopurine

Given orally

Intervention Type DRUG

vincristine

Given IV

Intervention Type DRUG

Other Intervention Names

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anti-CD52 monoclonal antibody Campath-1H MoAb CD52 Monoclonal Antibody Campath-1H Monoclonal Antibody CD52 ASNase Colaspase Crasnitin Elspar L-ASP amethopterin Folex methylaminopterin Mexate MTX Aeroseb-Dex Decaderm Decadron DM DXM CF CFR LV 6-mercaptopurine 6-MP Leukerin MP vincristine sulfate leurocristine sulfate VCR Vincasar PFS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Wiernik

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Mercy Hospital and Medical Center

Chicago, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Site Status

Edward H Kaplan MD and Associates

Skokie, Illinois, United States

Site Status

Carle Clinic-Urbana Main

Urbana, Illinois, United States

Site Status

Saint Anthony Memorial Health Center

Michigan City, Indiana, United States

Site Status

Siouxland Hematology Oncology Associates

Sioux City, Iowa, United States

Site Status

Mercy Medical Center-Sioux City

Sioux City, Iowa, United States

Site Status

Saint Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Cancer Center of Kansas-Liberal

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Site Status