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Sponsored by: |
Children's Hospital of Philadelphia |
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Information provided by: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT00579124 |
This is a pilot study with 2 strata to evaluate engraftment and graft vs. host disease (GVHD) in patients receiving unrelated or partially matched related donor peripheral stem cells with the CliniMACS system will be used to positively or negatively deplete T cells to prevent severe GVHD. Feasibility will be tested, focusing on engraftment, treatment-related mortality and severe GVHD
Stratum 1:
We will aim for a defined dose of CD3+ cells for patients with unrelated and well- matched related donors to ensure engraftment and potential graft vs. leukemia effect.
Stratum 2:
Complete T cell depletion for patients with haploidentical related donors by positive selection of CD 34+.
The CliniMACS device is investigational. The manufacturer of the devise is Miltenyi Biotec.
Condition | Intervention | Phase |
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Leukemia Bone Marrow Transplantation Immunodeficiencies |
Device: CliniMACs |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With CliniMACs Device for T-Cell Depletion |
Estimated Enrollment: | 60 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
We will aim for a defined dose of CD3+ cells for patients with unrelated and well- matched related donors to ensure engraftment and potential graft vs. leukemia effect. The CD3+ dose will be one log lower than the dose used in the previous study, CHP-730. In that study, all patients engrafted, but chronic GVHD was observed in 67% of evaluable patients. CD3+ cells will be collected and cryopreserved in aliquots in the event that donor lymphocyte infusions are needed for recurrent disease.
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Device: CliniMACs
T Cell depletion
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2
T cell depletion for patients with haploidentical related donors by positive selection of CD 34+.
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Device: CliniMACs
T Cell depletion
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PRIMARY HYPOTHESIS: T cell depletion utilizing the CliniMACS device will allow more precise, specific and controlled graft engineering of peripheral blood stem cells from unrelated and partially matched related donors without an increase in relapse or graft rejection and grade III or IV acute graft vs. host disease (GVHD).
SECONDARY HYPOTHESIS: Use of the CliniMACS device will allow defined levels of T cell depletion to reflect the risk of severe GVHD in the donor/recipient pair.
Thus Patients with a relatively lower risk of severe GVHD will be assigned to Stratum 1 and receive a graft with somewhat less T cell depletion and a defined level of reinfused T cells. Patients with higher risk of severe GVHD will be assigned to Stratum 2 and receive a more T cell-depleted graft.
PURPOSE This is a pilot study with 2 strata to evaluate engraftment and graft vs. host disease (GVHD) in patients receiving unrelated or partially matched related donor peripheral stem cells using the CliniMACS system to positively or negatively deplete T cells to prevent severe GVHD. Feasibility will be tested, focusing on engraftment, treatment-related mortality (with a specific focus on interstitial pneumonitis) and severe GVHD
Ages Eligible for Study: | up to 22 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Malignant
Leukemias/lymphomas:
Chronic myelogenous leukemia:
Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase.
Disease status: in remission
Non-malignant diseases:
Exclusion Criteria:
Patients who have had prior SCT/BMT are excluded for study enrollment
Contact: Patricia T Hankins, R.N. | 215 590-5168 | hankinsp@email.chop.edu |
Contact: Nancy J Bunin, M.D. | 215 590-2255 | buninn@email.chop.edu |
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Stephan Grupp, MD, PhD | Children's Hospital of Philadelphia |
Responsible Party: | Children's Hospital of Philadelphia ( Stephan Grupp, M.D., Ph.D. ) |
Study ID Numbers: | 2005-3-4222, CHP 834 |
Study First Received: | December 19, 2007 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00579124 |
Health Authority: | United States: Food and Drug Administration |
Blood and Marrow Transplant T cell Depletion Unrelated Related Donor |
Leukemia Immunologic Deficiency Syndromes |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |