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

Phase 1

Completed

• Conditions: Leukemia; Myelodysplastic Syndromes; Lymphoma; Multiple Myeloma; Plasma Cell Neoplasm
• Interventions: Biological: human myeloid progenitor cells

• Registration Number: NCT00891137
• Lead Sponsor: Cellerant Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	human myeloid progenitor cells	Intermediate dose, multiple donor CLT-008 (human myeloid progenitor cells)
Group A	human myeloid progenitor cells	Low dose, single donor CLT-008 (human myeloid progenitor cells)
Group B	human myeloid progenitor cells	Low dose, multiple donor CLT-008 (human myeloid progenitor cells)
Group D	human myeloid progenitor cells	High dose, multiple donor CLT-008 (human myeloid progenitor cells)

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	100 days post transplant

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Loyola University Medical Center, Cardinal Bernardin Cancer Center; 🇺🇸 Maywood, Illinois, United States

University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Cleveland Clinic, Taussig Cancer Institute; 🇺🇸 Cleveland, Ohio, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Alfred I. duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States