Safety Study of Human Myeloid Progenitor Cells (CLT-008)... | NCT00891137 | Trialant
NCT00891137
Sponsor
Cellerant Therapeutics
Status
Completed
Last Update Posted
Oct 27, 2014Estimated
Enrollment
30Actual
Phase
Phase 1
Conditions
Leukemia
Lymphoma
Multiple Myeloma
Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions
human myeloid progenitor cells
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00891137
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MT 2008-38
Secondary IDs
Not provided
Brief Title
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
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
Acronym
Not provided
Organization
Cellerant TherapeuticsINDUSTRY
Status Module
Record Verification Date
Oct 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2009
Primary Completion Date
Jun 2014Actual
Completion Date
Jun 2014Actual
First Submitted Date
Apr 30, 2009
First Submission Date that Met QC Criteria
Apr 30, 2009
First Posted Date
May 1, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 23, 2014
Last Update Posted Date
Oct 27, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Cellerant TherapeuticsINDUSTRY
Collaborators
Name
Class
Department of Health and Human Services
FED
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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