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

NCT ID: NCT00773149

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2011-07-31

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.

Conditions

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Acute Lymphocytic Leukemia

Keywords

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Adult Acute Lymphocytic Leukemia Alemtuzumab

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

all included patients

Group Type EXPERIMENTAL

Alemtuzumab (CAMPATH 1H) associated to G-CSF

Intervention Type DRUG

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.

Interventions

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Alemtuzumab (CAMPATH 1H) associated to G-CSF

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.

Intervention Type DRUG

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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Norbert Claude GORIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Saint Antoine Hospital, Hematology Unit

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P051003

Identifier Type: -

Identifier Source: org_study_id