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To Determine the Role of Adding Campath-1H or ATG Given In-vivo in Addition to Fludarabine and Low Dose Busulfex on Outcome in Patients Treated With Reduced Intensity Conditioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00226512
Recruitment Status : Withdrawn (the PI is no longer work at Hadassah)
First Posted : September 27, 2005
Last Update Posted : April 8, 2011
Information provided by:
Hadassah Medical Organization

Brief Summary:
Multi-institutional randomized phase III trial of a non-myeloablative preparative regimen with fludarabine and busulfex with or without anti-lymphocyte antibodies (monoclonal humanized Campath-1H administered s.c. or polyclonal rabbit anti-T lymphocyte antibodies (ATG), combined with low dose and short course cyclosporine A (CSA) and methotrexate (MTX) as the sole agent for prevention of graft-vs-host disease (GVHD) for patients with acute myelogenous leukemia or myelodysplastic syndrome undergoing allogeneic stem cell transplantation from an HLA compatible donor.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Drug: Campath-1H /ATG Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Trial of a Non-myeloablative Preparative Regimen With Fludarabine and Busulfan With or Without Anti-lymphocyte Antibodies (Campath-1H or ATG) for Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome Undergoing Allogeneic Stem Cell Transplantation From an HLA Compatible Donor
Study Start Date : July 2004

Primary Outcome Measures :
  1. To determine the efficacy of s.c. Campath-1H or ATG in decreasing the incidence and severity of acute and chronic GVHD in patients with AML and MDS treated with non-myeloablative stem cell transplantation.

Secondary Outcome Measures :
  1. Investigate the role of different conditioning regimens on:
  2. Infection, engraftment relapse rate and disease free survival.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of AML or MDS, with no lower or upper age limit:
  • a) Induction failure
  • b) First or subsequent remission
  • c) Untreated first relapse
  • Patients must have an HLA compatible donor willing and capable of donating peripheral blood stem cells (first choice) or bone marrow progenitor cells using conventional techniques and blood lymphocytes if indicated (HLA compatible defined as 5/6 or 6/6 matched related or 10/10 molecular matched unrelated donor (A,B,C,DR,DRB1).

Exclusion Criteria:

  • Donor contraindication (HIV seropositive confirmed by Western Blot, Hepatitis B antigenemia).
  • Evidence of bone marrow disease.
  • Unable to donate bone marrow or peripheral blood due to concurrent medical condition.

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 identifier (NCT number): NCT00226512

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Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
Layout table for additonal information Identifier: NCT00226512    
Other Study ID Numbers: 230704-HMO-CTIL
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: September 2005
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antineoplastic Agents, Immunological
Antineoplastic Agents