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Completed

NCT Number: NCT00773149

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

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.

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Key information

Conditions

Acute Lymphocytic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Saint Antoine Hospital, Hematology Unit

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Partial and complete remission, overall response rates

    Time frame: At 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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.

Acronym: Campath

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Oct 16, 2008
Registry last updated
Jul 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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