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

Phase 1

Completed

• Conditions: Acute Lymphocytic Leukemia
• Interventions: Drug: Alemtuzumab (CAMPATH 1H) associated to G-CSF

• Registration Number: NCT00773149
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Primary Completion: 2011-01
• Status Verified: 2011-02
• Study Completion: 2011-07
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Alemtuzumab (CAMPATH 1H) associated to G-CSF	all included patients

Primary Outcome Measures

Name	Time	Method
Partial and complete remission, overall response rates	At 2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Saint Antoine Hospital, Hematology Unit; 🇫🇷 Paris, France