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This study has been withdrawn prior to enrollment.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:
Hadassah Medical Organization
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
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Purpose
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00226512 History of Changes |
| Other Study ID Numbers: | 230704-HMO-CTIL |
| Study First Received: | September 9, 2005 |
| Last Updated: | April 7, 2011 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Fludarabine Alemtuzumab Campath 1G Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013