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

Primary Purpose

Acute Lymphocytic Leukemia

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Alemtuzumab (CAMPATH 1H) associated to G-CSF

About this trial

This is an interventional treatment trial for Acute Lymphocytic Leukemia focused on measuring Adult Acute Lymphocytic Leukemia, Alemtuzumab

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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:

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.

Sites / Locations

Saint Antoine Hospital, Hematology Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

all included patients

Outcomes

Primary Outcome Measures

Partial and complete remission, overall response rates

Secondary Outcome Measures

Valuation of tolerance, more particularly targeted at the immunodeficiency shortage, contagious complications and neurotoxicity assessed according to the NCI (National Cancer Institute) classification.

Valuation of the response waiting time, from the first day of the induction treatment to the REEVOLUTING.

Full Information

NCT ID

NCT00773149

First Posted

October 15, 2008

Last Updated

July 25, 2012

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00773149

Brief Title

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

Acronym

Campath

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphocytic Leukemia

Keywords

Adult Acute Lymphocytic Leukemia, Alemtuzumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

all included patients

Intervention Type

Drug

Intervention Name(s)

Alemtuzumab (CAMPATH 1H) associated to G-CSF

Intervention Description

Primary Outcome Measure Information:

Title

Partial and complete remission, overall response rates

Time Frame

At 2 years

Secondary Outcome Measure Information:

Title

Time Frame

At 2 years

Title

Valuation of the response waiting time, from the first day of the induction treatment to the REEVOLUTING.

Time Frame

at 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Norbert Claude GORIN, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint Antoine Hospital, Hematology Unit

City

Paris

ZIP/Postal Code

75012

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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