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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00773149
First received: October 15, 2008
Last updated: July 25, 2012
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Lymphocytic Leukemia
 Drug: Alemtuzumab (CAMPATH 1H) associated to G-CSF
 Phase 1
Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Partial and complete remission, overall response rates [ Time Frame: At 2 years ] [ Designated as safety issue: Yes ]

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. [ Time Frame: At 2 years ] [ Designated as safety issue: Yes ]
  • Valuation of the response waiting time, from the first day of the induction treatment to the REEVOLUTING. [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: October 2006
Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
all included patients
 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.

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

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773149

Locations
France
Saint Antoine Hospital, Hematology Unit
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Norbert Claude GORIN, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00773149     History of Changes
Other Study ID Numbers: P051003
Study First Received: October 15, 2008
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Adult Acute Lymphocytic Leukemia
Alemtuzumab

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Alemtuzumab
Campath 1G
Antibodies, Neoplasm
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013