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

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ClinicalTrials.gov Identifier: NCT00773149
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : July 26, 2012
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2006
Actual Primary Completion Date : January 2011
Actual Study Completion Date : July 2011


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Partial and complete remission, overall response rates [ Time Frame: At 2 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Valuation of the response waiting time, from the first day of the induction treatment to the REEVOLUTING. [ Time Frame: at 2 years ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00773149     History of Changes
Other Study ID Numbers: P051003
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: February 2011

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
Antineoplastic Agents