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.

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

sites

Case Western Reserve University, University Hospitals of Cleveland

Cleveland, Ohio 44106

from

Cleveland, OH