Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia

Study Overview
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Brief Summary
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Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. The present study will test the response rate (partial and complete remission) of refractory ALL or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be given for a hematopoietic stem cell transplant. The use of G-CSF is justified by a possible increase in ADCC.

Detailed Description
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All patients receive Alemtuzumab in 3 successive phases: Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance. Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented. Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months.

Official Title
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Phase I/II Study of Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia (ALL) or ALL in Relapse.

Conditions
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Acute Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Alemtuzumab (CAMPATH 1H) associated to G-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 15 years Refractory ALL ALL in relapse post chemotherapy or post transplant ALL blast cells expressing CD 52 antigen at any time during the evolution of the disease. Signed informed consent Patients under social security coverage Anti conceptional tablets in pre menopausal women. Exclusion Criteria: Children below 15 years of age or aged 15 Blast cells not expressing CD52 antigen (at all evaluations) HIV positivity ECOG Score 3 and 4 Hypersensitivity to Alemtuzumab. Pregnancy or breast feeding. Other malignant disease in addition to ALL.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>all included patients | Drug: Alemtuzumab (CAMPATH 1H) associated to G-CSF<br>* All patients receive Alemtuzumab in 3 successive phases: Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance. Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented. Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial and complete remission, overall response rates |  | At 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valuation of tolerance, more particularly targeted at the immunodeficiency shortage, contagious complications and neurotoxicity assessed according to the NCI (National Cancer Institute) classification. |  | At 2 years | 
| Valuation of the response waiting time, from the first day of the induction treatment to the REEVOLUTING. |  | at 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult Acute Lymphocytic Leukemia, Alemtuzumab