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

October 23, 2014 updated by: Cellerant Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center, Cardinal Bernardin Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic, Taussig Cancer Institute
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 100 days post transplant
100 days post transplant

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellerant Therapeutics

Collaborators

Department of Health and Human Services

Investigators

  • Principal Investigator: John E Wagner, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 30, 2009

First Submitted That Met QC Criteria

April 30, 2009

First Posted (Estimate)

May 1, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT 2008-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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