Cancer

Title
Umbilical Cord Blood Transplant Followed by Infusion at 24 Hours Post-Transplant of Blood Cells (Expanded Human Myeloid Progenitor Cells)
Trial Number
202837081810
Number of Participants
22
Principal Investigator

Patrick Stiff

M.D.
Hematology/Oncology
Coleman Professor of Oncology
Eligibility

Patients ages 12 - 65 (inclusive) scheduled to undergo UCB transplant with HLA 4-6/6 matched umbilical cord blood graft containing >3.0 x 107 nucleated cells/kilogram (cryopreserved)) meeting one of the following disease criteria may be eligible:

Acute myeloid leukemia(AML): high-risk CR1 as evidenced by preceding myelodysplastic syndromes (MDS), high-risk cytogenetics, =two cycles to obtain CR, erythroblastic or megakaryocytic leukemia; CR2+. All patients must be in CR as defined by hematological criteria, e.g. a

Very high risk pediatric patients with AML: Patients

Acute lymphocytic leukemia: high-risk CR1 [t(9;22), t (1;19), t(4;11) or other mixed lineage leukemia rearrangements] or >one cycle to obtain CR, CR2+. All patients must be in CR as defined by hematological recovery, e.g.

Chronic myelogenous leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1), patient must have failed or be intolerant to imatinib mesylate or in accelerated phase or in second chronic phase.

MDS IPSS Int-2 or high-risk or refractory anemia with severe pancytopenia or high-risk cytogenetics: Blasts must be

Chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone B-cell lymphoma or follicular lymphoma that has progressed after at least two prior therapies: Patients with bulky disease (nodal mass >five cm) should be considered for debulking chemotherapy before transplant.

Lymphoplasmacytic lymphoma, mantle-cell lymphoma or prolymphocytic leukemia: eligible after initial therapy in CR1+ or PR1+.

Large-cell non-Hodgkin’s lymphoma (NHL) in >CR2 or >PR2: Patients in CR2 or PR2 with initial short remission (two salvage regimens) is NOT eligible.

Lymphoblastic lymphoma, Burkitt’s lymphoma and other high-grade NHL after initial therapy if stage III/IV in CR1 or PR1 or after progression if stage I/II two salvage regimens) is NOT eligible.

Multiple myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than six months, or ß-2 microglobulin >three mg/L, may be considered for this protocol after initial therapy.

Purpose

The purpose of this study is to measure the safety of ex vivo expanded human myeloid progenitor cells. Expanded human myeloid progenitor cells have the ability to make red blood cells, platelets and some kinds of white blood cells.

Enrollment

(708) 327-3304

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