Infusion of Off-the-Shelf Expanded Cord Blood Cells to Augment Cord Blood Transplant in Patients With Hematologic Malignancies

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Accelerated Phase Chronic Myelogenous LeukemiaAdult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Childhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in RemissionChildhood Chronic Myelogenous LeukemiaChildhood Myelodysplastic SyndromesChronic Phase Chronic Myelogenous Leukemiade Novo Myelodysplastic SyndromesPreviously Treated Myelodysplastic SyndromesRefractory AnemiaRefractory Anemia With Excess BlastsRefractory Anemia With Excess Blasts in TransformationRelapsing Chronic Myelogenous LeukemiaSecondary Myelodysplastic Syndromes
Interventions
PROCEDURE

umbilical cord blood transplantation

Undergo unmanipulated umbilical cord blood transplant

DRUG

fludarabine phosphate

Given IV

DRUG

cyclophosphamide

Given IV

BIOLOGICAL

ex vivo-expanded cord blood progenitor cell infusion

Undergo ex-vivo expanded cryopreserved cord blood progenitor cells

RADIATION

total-body irradiation

Undergo TBI

DRUG

cyclosporine

Given IV

DRUG

mycophenolate mofetil

Given IV and PO

OTHER

laboratory biomarker analysis

Correlative studies

Trial Locations (1)

98109

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle

Sponsors
All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Fred Hutchinson Cancer Center

OTHER

lead

Nohla Therapeutics, Inc.

INDUSTRY