Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Negrin, Stanford University
ClinicalTrials.gov Identifier:
NCT00186342
First received: September 13, 2005
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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).


Condition Intervention
Acute Disease
Myelodysplastic Syndromes
Leukemia, Myeloid, Chronic
Myeloproliferative Disorders
Blood and Marrow Transplant (BMT)
Myelodysplastic Syndromes (MDS)
Leukemia
Procedure: ablative allogeneic hematopoietic cell transplantation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Sibling and Unrelated Donor Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Busulfan, Etoposide and Cyclophosphamide

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • tolerability [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
  • efficacy of therapy [ Time Frame: unknown ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • compare efficacy of this treatment to historical controls [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 1992
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: ablative allogeneic hematopoietic cell transplantation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   51 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00186342

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Robert S Negrin Stanford University
  More Information

No publications provided

Responsible Party: Robert Negrin, Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00186342     History of Changes
Other Study ID Numbers: BMT45, 75274, BMT45
Study First Received: September 13, 2005
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Leukemia
Syndrome
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Acute Disease
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Neoplasms by Histologic Type
Disease
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on September 18, 2014