search
Back to results

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

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndrome

Status
Withdrawn
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Campath-1H /ATG
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Organization

Outcomes

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.

Full Information

First Posted
September 9, 2005
Last Updated
April 7, 2011
Sponsor
Hadassah Medical Organization
Collaborators
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT00226512
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Withdrawn
Why Stopped
the PI is no longer work at Hadassah
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization
Collaborators
Bayer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
203 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Campath-1H /ATG
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Investigate the role of different conditioning regimens on:
Title
Infection, engraftment relapse rate and disease free survival.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shimon Slavin, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs