Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Cellerant Therapeutics
ClinicalTrials.gov Identifier:
NCT00891137
First received: April 30, 2009
Last updated: October 23, 2014
Last verified: October 2014
History of Changes
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Multiple Myeloma
Plasma Cell Neoplasm
Myelodysplastic Syndromes
 Biological: human myeloid progenitor cells
 Phase 1

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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia, Childhood Acute Monoblastic Leukemia Acute Myeloblastic Leukemia Type 5 Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia, Childhood Acute Non Lymphoblastic Leukemia B-cell Lymphomas Burkitt Lymphoma Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Follicular Lymphoma Leukemia, B-cell, Chronic Leukemia, Myeloid Lymphoblastic Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Lymphosarcoma Mantle Cell Lymphoma Multiple Myeloma Myelodysplastic Syndromes Plasmablastic Lymphoma Small Non-cleaved Cell Lymphoma Squamous Cell Carcinoma of the Head and Neck Waldenstrom Macroglobulinemia
U.S. FDA Resources

Further study details as provided by Cellerant Therapeutics:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 100 days post transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Neutrophil and platelet recovery [ Time Frame: 100 days post transplant ] [ Designated as safety issue: No ]
  • Persistence of CLT-008 derived cells [ Time Frame: 100 days post transplant ] [ Designated as safety issue: No ]
  • Graft-versus-host disease (GVHD) [ Time Frame: 100 days post transplant ] [ Designated as safety issue: Yes ]
  • Non-relapse mortality [ Time Frame: 100 days post transplant ] [ Designated as safety issue: Yes ]
  • Infections [ Time Frame: 42 days post transplant ] [ Designated as safety issue: No ]
Enrollment: 30
Study Start Date: April 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891137

Locations
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Illinois
Loyola University Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
United States, Minnesota
University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Cellerant Therapeutics
Department of Health and Human Services
Investigators
Principal Investigator: John E Wagner, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
Cellerant Therapeutics, Inc.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Cellerant Therapeutics
ClinicalTrials.gov Identifier: NCT00891137     History of Changes
Other Study ID Numbers: MT 2008-38
Study First Received: April 30, 2009
Last Updated: October 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cellerant Therapeutics:
adult acute myeloid leukemia 11q23 (MLL) abnormalities
adult acute myeloid leukemia inv(16)(p13;q22)
adult acute myeloid leukemia t(15;17)(q22;q12)
adult acute myeloid leukemia t(16;16)(p13;q22)
adult acute myeloid leukemia t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
chronic phase chronic myelogenous leukemia
 de novo myelodysplastic syndromes
extranodal marginal zone B-cell lymphoma
mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
stage I adult Burkitt lymphoma
contiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult Burkitt lymphoma
Waldenstrom macroglobulinemia
noncontiguous stage II adult immunoblastic
contiguous stage II adult immunoblastic
large cell lymphoma
stage I adult immunoblastic large cell lymphoma
previously treated myelodysplastic syndromes
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma

Additional relevant MeSH terms:
Multiple Myeloma
Myelodysplastic Syndromes
Preleukemia
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
 Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Paraproteinemias
Precancerous Conditions
Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015