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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

This study has been withdrawn prior to enrollment.
(the PI is no longer work at Hadassah)
Information provided by:
Hadassah Medical Organization Identifier:
First received: September 9, 2005
Last updated: April 7, 2011
Last verified: September 2005
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 Intervention Phase
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Drug: Campath-1H /ATG
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

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

Estimated Enrollment: 203
Study Start Date: July 2004

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT00226512

Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
  More Information Identifier: NCT00226512     History of Changes
Other Study ID Numbers: 230704-HMO-CTIL
Study First Received: September 9, 2005
Last Updated: April 7, 2011

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017