Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
NCT ID: NCT00891137
Last Updated: 2014-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2009-04-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group A
Low dose, single donor CLT-008 (human myeloid progenitor cells)
human myeloid progenitor cells
Single intravenous injection/infusion
Group B
Low dose, multiple donor CLT-008 (human myeloid progenitor cells)
human myeloid progenitor cells
Single intravenous injection/infusion
Group C
Intermediate dose, multiple donor CLT-008 (human myeloid progenitor cells)
human myeloid progenitor cells
Single intravenous injection/infusion
Group D
High dose, multiple donor CLT-008 (human myeloid progenitor cells)
human myeloid progenitor cells
Single intravenous injection/infusion
Interventions
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human myeloid progenitor cells
Single intravenous injection/infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Active infection
* HIV positive
* Pregnant or nursing
12 Years
65 Years
ALL
No
Sponsors
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Department of Health and Human Services
FED
Cellerant Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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John E Wagner, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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Children's Hospital of Orange County
Orange, California, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Loyola University Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States
University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center
Minneapolis, Minnesota, United States
Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Related Links
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Cellerant Therapeutics, Inc.
Other Identifiers
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MT 2008-38
Identifier Type: -
Identifier Source: org_study_id
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