Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | March 2011 |
| Contact: | Rod Van Syoc |
| Email: | rvansyoc@cellerant.com |
| Phone: | 650-232-2124 |
A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia
Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to
accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in
patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid
leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this
study, the safety, tolerability and activity of CLT-008 administered after "standard of
care" cytarabine-based consolidation or induction/re-induction chemotherapy will be
determined by monitoring for adverse reactions, infusion reactions, graft-versus host
disease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections and
complications.
accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in
patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid
leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this
study, the safety, tolerability and activity of CLT-008 administered after "standard of
care" cytarabine-based consolidation or induction/re-induction chemotherapy will be
determined by monitoring for adverse reactions, infusion reactions, graft-versus host
disease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections and
complications.
Key Inclusion Criteria:
- Hematological malignancy, including:
- AML, ALL or MDS
- Planned treatment with cytarabine-based chemotherapy regimen
- Adequate hepatic, renal, hematologic, cardiac and respiratory function
Key Exclusion Criteria:
- Prior allograft or history of active GVHD within 3 years
- Pregnant or nursing
We found this trial at
11
sites
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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3855 Health Sciences Dr,
La Jolla, California 92093
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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505 Parnassus Ave
San Francisco, California 94143
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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