Unrelated And Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha/Beta T Cell And B Cell Depletion For Patients With Hematologic Malignancies

Overview

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.
SparkCures ID 1577
Trial Phase Phase 2
Enrollment 140 Patients
Treatments
Tags
Trial Sponsors
  • Children's Hospital of Philadelphia
NCT Identifier

NCT02323867

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

1. 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
2. Acceptable organ status clearance
3. No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic
4. Signed informed consent.
5. Negative pregnancy test for females of childbearing potential.

Exclusion Criteria:

1. Patients who do not meet disease, organ or infectious criteria.
2. No suitable donor
3. 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.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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