Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00186342
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 17, 2012
Information provided by (Responsible Party):
Robert Negrin, Stanford University

September 13, 2005
September 16, 2005
December 17, 2012
September 1992
January 2009   (Final data collection date for primary outcome measure)
  • tolerability
  • efficacy of therapy
  • - Tolerability
  • - Efficacy
Complete list of historical versions of study NCT00186342 on Archive Site
compare efficacy of this treatment to historical controls
Same as current
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Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies
Allogeneic Sibling and Unrelated Donor Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Busulfan, Etoposide and Cyclophosphamide
The purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD).
To learn whether a new preparative regimen to prepare patients for bone marrow transplantation is useful in patients above 50 years of age and whether it is useful in patients with myelodysplastic syndromes.
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Disease
  • Myelodysplastic Syndromes
  • Leukemia, Myeloid, Chronic
  • Myeloproliferative Disorders
  • Blood and Marrow Transplant (BMT)
  • Myelodysplastic Syndromes (MDS)
  • Leukemia
Procedure: ablative allogeneic hematopoietic cell transplantation
Experimental: CIK cell
The initial dose utilized will be 1x107 expanded cells/kg. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD.
Intervention: Procedure: ablative allogeneic hematopoietic cell transplantation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2009
January 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:1) Patients aged 51-60 with acute non-lymphocytic leukemia in first or subsequent remission and acute lymphocytic leukemia in first remission with high risk features which include elevated white blood cell count at presentation, cytogenetic abnormalities, extramedullary leukemia, ALL in greater than first remission and patients with chronic myelogenous leukemia at any stage who have a histocompatible sibling donor.

2) Patients with myelodysplastic syndrome including patients with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation.

3) Patients with myeloproliferative disorders which give them poor long-term disease-free survival, such as myeloid metaplasia or myeloid fibrosis.

4) Patients with secondary myelodysplasia following cytotoxic chemotherapy.

Exclusion Criteria:- Organ dysfunction

Sexes Eligible for Study: All
51 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Robert Negrin, Stanford University
Stanford University
Not Provided
Principal Investigator: Robert S Negrin Stanford University
Stanford University
December 2012

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