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Allogeneic Transplantation From Related Haploidentical Donors in Older Patients With Indolent Hematologic Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Lowsky, Stanford University
ClinicalTrials.gov Identifier:
NCT00185692
First received: September 12, 2005
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

The purpose of the study is to evaluate the feasibility and safety of transplanting CD34+ selected hematopoietic cells from a haploidentical related donor following a nonmyeloablative regimen of total lymphoid irradiation (TLI) and antithymocyte globulin (ATG).


Condition Intervention Phase
Blood Cancer
Leukemia
Procedure: non-myeloablative hematopoietic cell transplantation
Drug: Anti-Thymocyte Globulin
Drug: Cyclosporine
Drug: Mycophenolate Mofetil
Drug: G-CSF
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Hematopoietic Cell Transplantation of Positively Selected CD34+ Cells and Defined Inoculum of T Cells From Related Haploidentical Donors for Older Patients With Indolent Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Assess safety and feasibility of using a non-myeloablative conditioning regimen of total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) to achieve engraftment of haploidentical CD34+ selected peripheral blood stem cells in older patients or [ Time Frame: 1st 100 days after transplant and yearly intervals thereafter ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: August 2000
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: non-myeloablative hematopoietic cell transplantation
    Total lymphoid irradiation and anti-thymocyte globulin. Infusion of the donor graft Post-transplant immunosuppression with cyclosporin and mycophenolate mofetil.
    Other Name: peripheral-blood stem-cell transplantation
    Drug: Anti-Thymocyte Globulin
    1.5 mg/kg QD x 5, IV
    Other Name: ATG
    Drug: Cyclosporine
    5 mg/kg BID, PO
    Other Names:
    • INN/BAN
    • USAN
    Drug: Mycophenolate Mofetil
    15 mg/kg Q 8 hours, PO
    Other Names:
    • MMF
    • CellCept
    Drug: G-CSF
    16 mcg/kg, SQ
    Other Name: Granulocyte colony-stimulating factor
Detailed Description:

The purpose of the study is to assess safety and feasibility of using a non-myeloablative conditioning regimen of total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) to achieve engraftment of haploidentical CD34+ selected peripheral blood stem cells in older patients or patients with underlying medical conditions that preclude standard allogeneic treatment.

  Eligibility

Ages Eligible for Study:   12 Months to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- a haploidentical donor is available

Exclusion Criteria:

  • rapidly progressive disease
  • organ dysfunction
  • documented fungal disease
  • HIV positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185692

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

No publications provided

Responsible Party: Robert Lowsky, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00185692     History of Changes
Other Study ID Numbers: BMT124, 75117, BMT124
Study First Received: September 12, 2005
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hematologic Neoplasms
Hematologic Diseases
Neoplasms
Neoplasms by Site
Antilymphocyte Serum
Cyclosporine
Cyclosporins
Lenograstim
Mycophenolate mofetil
Mycophenolic Acid
Adjuvants, Immunologic
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014