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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891137
• Other study ID #: MT 2008-38
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2009
• Last updated: October 23, 2014
• Start date: April 2009
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: Cellerant Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndromes
• Neoplasms, Plasma Cell
• Plasma Cell Neoplasm
• Plasmacytoma
• Preleukemia

Intervention

Biological:
• human myeloid progenitor cells
Single intravenous injection/infusion

Locations

Country	Name	City	State
United States	Cleveland Clinic, Taussig Cancer Institute	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Loyola University Medical Center, Cardinal Bernardin Cancer Center	Maywood	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center	Minneapolis	Minnesota
United States	Children's Hospital of Orange County	Orange	California
United States	Children's National Medical Center	Washington	District of Columbia
United States	Alfred I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Cellerant Therapeutics	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		100 days post transplant	Yes
Secondary	Neutrophil and platelet recovery		100 days post transplant	No
Secondary	Persistence of CLT-008 derived cells		100 days post transplant	No
Secondary	Graft-versus-host disease (GVHD)		100 days post transplant	Yes
Secondary	Non-relapse mortality		100 days post transplant	Yes
Secondary	Infections		42 days post transplant	No

External Links

•   Cellerant Therapeutics, Inc.