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Blood Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

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ClinicalTrials.gov Identifier: NCT00038779
Recruitment Status : Terminated (Lack of Accrual)
First Posted : June 7, 2002
Last Update Posted : August 6, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess early treatment failure within 100 days and to assess the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and survival.

Condition or disease Intervention/treatment
Leukemia Non Hodgkin's Lymphoma Aplastic Anemia Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States
Study Start Date : August 1996
Primary Completion Date : September 2004
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Megadose T cell depleted Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Patients with acute leukemia, lymphoma that failed to respond or relapsed after chemotherapy or CML beyond first chronic phase.
  • Patients with aplastic anemia or myelodysplasia which failed to respond to primary therapy are eligible.
  • Patients with low grade lymphoma or CLL will only be eligible if they failed two chemotherapy regimens and have stage IV disease.
  • Patients must be <age 50 with a related haploidentical donor (phenotypically one, two or three HLA A, B and DR antigen mismatched) donor.
  • Patients should have adequate hepatic and renal function with a bilirubin of less than or equal to 1.5mg%, SGPT less than or equal to 3x the upper limits of normal, and creatine less than or equal to 1.5mg%.
  • Patients with serious intercurrent medical illness are not eligible.
  • Patients and their donors must provide written informed consent.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038779


Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
More Information

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038779     History of Changes
Other Study ID Numbers: DM96-122
First Posted: June 7, 2002    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012

Keywords provided by M.D. Anderson Cancer Center:
Lymphoma
CML
CLL
AML
ALL
MDS
AA

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Anemia, Aplastic
Pancytopenia
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anemia
Hematologic Diseases
Bone Marrow Diseases