ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00891137
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : October 27, 2014
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Cellerant Therapeutics

April 30, 2009
May 1, 2009
October 27, 2014
April 2009
June 2014   (Final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 100 days post transplant ]
Safety and tolerability
Complete list of historical versions of study NCT00891137 on ClinicalTrials.gov Archive Site
  • Neutrophil and platelet recovery [ Time Frame: 100 days post transplant ]
  • Persistence of CLT-008 derived cells [ Time Frame: 100 days post transplant ]
  • Graft-versus-host disease (GVHD) [ Time Frame: 100 days post transplant ]
  • Non-relapse mortality [ Time Frame: 100 days post transplant ]
  • Infections [ Time Frame: 42 days post transplant ]
  • Proportion of patients with an ANC ≥ 500/µL at day 14
  • Median time to neutrophil recovery and platelet recovery
  • Incidence of platelet refractoriness
  • Incidence of neutrophil recovery at day 42
  • Incidence of platelet recovery at day 100
  • Incidence of total chimerism at days 7, 14, 21, 28, 60, and 100
  • Proportion of cells derived from the CLT-008 product at days 7, 14, 21, 28, 60, and 100
  • Incidence of grade II-IV and grade III-IV acute graft-versus-host disease at day 100
  • Incidence of non-relapse mortality at day 100
  • Incidence of infection at day 42
Not Provided
Not Provided
 
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
  • CLT-008
  • hMPC
  • Experimental: Group A
    Low dose, single donor CLT-008 (human myeloid progenitor cells)
    Intervention: Biological: human myeloid progenitor cells
  • Experimental: Group B
    Low dose, multiple donor CLT-008 (human myeloid progenitor cells)
    Intervention: Biological: human myeloid progenitor cells
  • Experimental: Group C
    Intermediate dose, multiple donor CLT-008 (human myeloid progenitor cells)
    Intervention: Biological: human myeloid progenitor cells
  • Experimental: Group D
    High dose, multiple donor CLT-008 (human myeloid progenitor cells)
    Intervention: Biological: human myeloid progenitor cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
25
June 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00891137
MT 2008-38
No
Not Provided
Not Provided
Cellerant Therapeutics
Cellerant Therapeutics
Department of Health and Human Services
Principal Investigator: John E Wagner, MD University of Minnesota - Clinical and Translational Science Institute
Cellerant Therapeutics
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP