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

Acute Lymphocytic Leukemia Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773149
• Other study ID #: P051003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 15, 2008
• Last updated: July 25, 2012
• Start date: October 2006
• Est. completion date: July 2011

Study information

• Verified date: February 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	Saint Antoine Hospital, Hematology Unit	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial and complete remission, overall response rates		At 2 years	Yes
Secondary	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	Yes
Secondary	Valuation of the response waiting time, from the first day of the induction treatment to the REEVOLUTING.		at 2 years	Yes