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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acute Lymphocytic Leukemia

Treatments

Drug: Alemtuzumab (CAMPATH 1H) associated to G-CSF

Study type

Interventional

Funder types

Other

Identifiers

NCT00773149

P051003

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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