Status:
COMPLETED
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
Lead Sponsor:
Cellerant Therapeutics
Collaborating Sponsors:
Department of Health and Human Services
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
12-65 years
Phase:
PHASE1
Brief Summary
Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery in patients receiving myeloablative conditioning as part of an umbilical cord bloo...
Eligibility Criteria
Inclusion
- Key
- Undergoing allogeneic (4-6/6 matched) umbilical cord blood graft with at least 2.5 x 10e7 cells/kg for hematological malignancy:
- High risk acute myeloid leukemia (AML) in complete remission
- Very high risk pediatric AML; patients \<21 years eligible with \<25% blasts in marrow after failed chemotherapy
- High risk acute lymphocytic leukemia (ALL) in complete remission
- Chronic myelogenous leukemia (CML), excluding refractory blast crisis
- Myelodysplasia (MDS) IPPS Int-2 or high risk, or refractory anemia with severe pancytopenia or high risk cytogenetics
- Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), marginal zone B-cell lymphoma or follicular lymphoma that have progressed after two prior therapies
- Lymphoplasmacytic, lymphoma, mantle-cell lymphoma, prolymphocytic leukemia after initial therapy and complete or partial remission
- Large cell non-Hodgkin lymphoma (NHL) in second complete or partial remission (chemotherapy refractory large cell NHL not eligible)
- Lymphoblastic lymphoma, peripheral T cell lymphoma including angioimmunoblastic lymphoma, Burkitt's lymphoma, and other high-grade NHL after initial therapy if stage III/IV in complete or partial remission, or after progression if stage I/II \<1 year (chemotherapy refractory high-grade NHL not eligible)
- Multiple myeloma beyond 2nd partial remission
- Preparative regimen consisting of cyclophosphamide, fludarabine, and total body irradiation
- Adequate organ function
- Key
Exclusion
- Symptomatic underlying pulmonary disease or requiring oxygen
- Active infection
- HIV positive
- Pregnant or nursing
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00891137
Start Date
April 1 2009
End Date
June 1 2014
Last Update
October 27 2014
Active Locations (8)
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1
Children's Hospital of Orange County
Orange, California, United States, 92868
2
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
Loyola University Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153