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CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transportation With the CliniMACs Device for T and B Cell Depletion


Phase 2
N/A
22 Years
Open (Enrolling)
Both
Leukemia, Bone Marrow Transplantation, Immunodeficiencies

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Trial Information

CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transportation With the CliniMACs Device for T and B Cell Depletion


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 lesser T cell depletion and a defined level of reinfused T cells.
Patients with higher risk of severe GVHD or for whom there is no perceived clinical benefit
of GVHD will be assigned to Stratum 2 and receive a more T cell-depleted graft.

Conditioning of the patient (except immunodeficiencies) includes :

- Thiotepa 5 mg/kg days for 2 days

- Cyclophosphamide 60 mg/kg days for 2 days

- Total body irradiation 200 cGy given twice a day for 3 days

Following conditioning patient's will receive stem cells that have been processed using the
CliniMACS device. This processing is done in the stem cell laboratory at The Children's
Hospital of Philadelphia. The Stem Cell Lab is accredited by the Foundation for the
Accreditation of Cellular Therapy (FACT) and maintain complete standard operating procedures
(SOP's) and procedure records.

Processing of cells using the CliniMACS will occur in accordance with the Investigator
Brochure and Technical Manual following the laboratory SOPs and using aseptic technique. The
CHOP Stem Cell Lab has extensive prior experience with automated cell processing
technologies, including the CellPro Ceprate device and the Isolex 300i.


Inclusion Criteria:



1. 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

2. Non-malignant diseases:

1. Bone marrow failure, including severe aplastic anemia

2. Immunodeficiencies

Exclusion Criteria:

1. Patients who have had prior stem cell transplant (SCT) and bone marrow transplant
(BMT) are excluded for study enrollment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

Stephan Grupp, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital of Philadelphia

Authority:

United States: Food and Drug Administration

Study ID:

2005-3-4222

NCT ID:

NCT00579124

Start Date:

March 2005

Completion Date:

March 2015

Related Keywords:

  • Leukemia
  • Bone Marrow Transplantation
  • Immunodeficiencies
  • Blood and Marrow Transplant
  • T cell Depletion
  • Unrelated
  • Related
  • Donor
  • Immunologic Deficiency Syndromes
  • Leukemia

Name

Location
The Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104