Myelodysplastic Syndrome Clinical Trial

Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies

Summary

This is a single arm pilot study for patients using α/β T cell-depleted peripheral Stem Cell Transplantation (PSCT) in with alternative donor sources with hematologic malignancies receiving alternative donor (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and graft versus host disease (GVHD), and one year leukemia free survival.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Leukemias/lymphomas

Acute myeloid leukemia, primary or secondary Disease status: remission or <10% bone marrow blasts
Myelodysplasia
Acute lymphoblastic leukemia Disease status: in hematologic remission
Chronic myelogenous leukemia Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase.
Mixed lineage or biphenotypic acute leukemia
Lymphoblastic lymphoma Disease status: remission
Burkitt's lymphoma/leukemia: Disease status- in remission
Acceptable organ status clearance
No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic
Signed informed consent.
Negative pregnancy test for females of childbearing potential.

Exclusion Criteria:

Patients who do not meet disease, organ or infectious criteria.
No suitable donor
Received previous allogeneic transplant

Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele or a related, HLA match other than a sibling.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT02323867

Recruitment Status:

Recruiting

Sponsor:

Children's Hospital of Philadelphia

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There is 1 Location for this study

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The Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19103, United States More Info
Margaret Tartaglione, RN
Contact
215-590-4029
[email protected]
Patricia Hankins, RN
Contact
215-590-5168
[email protected]
Nancy J Bunin, MD
Principal Investigator
Stephan A Grupp, MD, PhD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT02323867

Recruitment Status:

Recruiting

Sponsor:


Children's Hospital of Philadelphia

How clear is this clinincal trial information?

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