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	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Active 18 and over Other 230704-HMO-CTIL
NCT00226512

Trial Description

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.

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Hadassah University Hospital

Bayer Corporation

Shimon Slavin, MD

Principal Investigator

Shimon Slavin, MD		Ph: +972-2-6776561
		Email: slavin@hadassah.org.il

Michael Y Shapira, MD		Ph: +972-2-6778351
		Email: shapiram@hadassah.org.il

Trial Sites

Israel

Jerusalem

Hadassah University Hospital

Arik Tzukert, DMD Ph: +972-2-6776095

Email: arik@hadassah.org.il

Hadas Lemberg, PhD Ph: +972-2-6777572

Email: lhadas@hadassah.org.il

Shimon Slavin, MD Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00226512
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.