Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Lymphoma, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 12 - 65 |
| Updated: | 5/5/2014 |
| Start Date: | April 2009 |
| Contact: | Rod Van Syoc |
| Email: | rvansyoc@cellerant.com |
| Phone: | 650-232-2124 |
A Phase I Trial to Determine Safety and Tolerability of Ex Vivo Expanded Human Myeloid Progenitor Cells (CLT-008) Infused 24 Hours Post-Transplant to Support Allogeneic Umbilical Cord Blood Transplantation for Hematologic Malignancies
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 blood transplant for hematologic cancer. In this study, the safety and
tolerability of CLT-008 administered 24 hours after an umbilical cord blood transplant will
be determined by monitoring for adverse reactions, neutrophil and platelet recovery,
hematopoietic chimerism, graft-versus-host disease (GVHD), and infections.
accelerate neutrophil recovery in patients receiving myeloablative conditioning as part of
an umbilical cord blood transplant for hematologic cancer. In this study, the safety and
tolerability of CLT-008 administered 24 hours after an umbilical cord blood transplant will
be determined by monitoring for adverse reactions, neutrophil and platelet recovery,
hematopoietic chimerism, graft-versus-host disease (GVHD), and infections.
Key Inclusion Criteria:
- 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 Criteria:
- Symptomatic underlying pulmonary disease or requiring oxygen
- Active infection
- HIV positive
- Pregnant or nursing
We found this trial at
10
sites
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Minneapolis, Minnesota 55455
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111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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