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Unrelated/Partially Matched Related Donor Peripheral Stem Cell Transplantation With CliniMACs Device for T-cell Depletion
This study is currently recruiting participants.
Verified by Children's Hospital of Philadelphia, July 2009
First Received: December 19, 2007   Last Updated: July 23, 2009   History of Changes
Sponsored by: Children's Hospital of Philadelphia
Information provided by: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00579124
  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 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
Leukemia
Bone Marrow Transplantation
Immunodeficiencies
Device: CliniMACs
Phase II

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

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Rates of success of engraftment, day 100 treatment related mortality, acute GVHD, relapse and EBV LPD. Patients who die will be considered failure for the engraftment success evaluation, and relapsed for that endpoint. [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

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
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.
Device: CliniMACs
T Cell depletion
2
T cell depletion for patients with haploidentical related donors by positive selection of CD 34+.
Device: CliniMACs
T Cell depletion

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   up to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Malignant

Leukemias/lymphomas:

  1. Acute myeloid leukemia, primary or secondary Disease status: remission or <10% peripheral blasts
  2. Myelodysplasia
  3. Acute lymphoblastic leukemia Disease status: in remission
  4. Chronic myelogenous leukemia:

    Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase.

  5. Mixed lineage or biphenotypic acute leukemia
  6. Lymphoblastic lymphoma Disease status: remission
  7. Burkitt's lymphoma/leukemia:

Disease status: in remission

Non-malignant diseases:

  1. Bone marrow failure, including severe aplastic anemia
  2. Immunodeficiencies

Exclusion Criteria:

Patients who have had prior SCT/BMT are excluded for study enrollment

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579124

Contacts
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

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Stephan Grupp, MD, PhD Children's Hospital of Philadelphia
  More Information

No publications provided

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: July 23, 2009
ClinicalTrials.gov Identifier: NCT00579124     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Blood and Marrow Transplant
T cell Depletion
Unrelated
Related
Donor

Study placed in the following topic categories:
Leukemia
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Leukemia
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 10, 2009