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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This study has been withdrawn prior to enrollment.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)
Sponsor:
Collaborator:
Bayer
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00226512
First received: September 9, 2005
Last updated: April 7, 2011
Last verified: September 2005
History of Changes

September 9, 2005
April 7, 2011
July 2004
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00226512 on ClinicalTrials.gov Archive Site
  • Investigate the role of different conditioning regimens on:
  • Infection, engraftment relapse rate and disease free survival.
Same as current
Not Provided
Not Provided
 
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
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
Drug: Campath-1H /ATG
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
203
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00226512
230704-HMO-CTIL
Not Provided
Not Provided
Hadassah Medical Organization
Bayer
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
Hadassah Medical Organization
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP