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

NCT00773149 | Completed Phase 1 DMC

• 1 other identifier: P051003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphocytic Leukemia

Keywords

Adult Acute Lymphocytic Leukemia; Alemtuzumab

Outcome Measures

Primary Outcomes (1)

• Partial and complete remission, overall response rates

  At 2 years

Secondary Outcomes (2)

• 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

Study Arms (1)

1

EXPERIMENTAL

all included patients

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

Interventions

Alemtuzumab (CAMPATH 1H) associated to G-CSF 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.

1

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Antoine Hospital, Hematology Unit

Paris, 75012, France

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Norbert Claude GORIN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: October 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 26, 2012

Record last verified: 2011-02

Locations

FR (1)