Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy

Sponsor

Cellerant Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00891137

Collaborator

Department of Health and Human Services (U.S. Fed)

Enrollment

Locations

Arms

Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma Multiple Myeloma Plasma Cell Neoplasm Myelodysplastic Syndromes	Biological: human myeloid progenitor cells	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Low dose, single donor CLT-008 (human myeloid progenitor cells)	Biological: human myeloid progenitor cells Single intravenous injection/infusion Other Names: CLT-008 hMPC
Experimental: Group B Low dose, multiple donor CLT-008 (human myeloid progenitor cells)	Biological: human myeloid progenitor cells Single intravenous injection/infusion Other Names: CLT-008 hMPC
Experimental: Group C Intermediate dose, multiple donor CLT-008 (human myeloid progenitor cells)	Biological: human myeloid progenitor cells Single intravenous injection/infusion Other Names: CLT-008 hMPC
Experimental: Group D High dose, multiple donor CLT-008 (human myeloid progenitor cells)	Biological: human myeloid progenitor cells Single intravenous injection/infusion Other Names: CLT-008 hMPC

Outcome Measures

Primary Outcome Measures

Safety and tolerability [100 days post transplant]

Secondary Outcome Measures

Neutrophil and platelet recovery [100 days post transplant]
Persistence of CLT-008 derived cells [100 days post transplant]
Graft-versus-host disease (GVHD) [100 days post transplant]
Non-relapse mortality [100 days post transplant]
Infections [42 days post transplant]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	District of Columbia	United States	20010
4	Loyola University Medical Center, Cardinal Bernardin Cancer Center	Maywood	Illinois	United States	60153
5	University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center	Minneapolis	Minnesota	United States	55455
6	Cleveland Clinic, Taussig Cancer Institute	Cleveland	Ohio	United States	44195
7	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
8	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226