Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
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ClinicalTrials.gov Identifier: NCT00891137 |
Recruitment Status
:
Completed
First Posted
: May 1, 2009
Last Update Posted
: October 27, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia Lymphoma Multiple Myeloma Plasma Cell Neoplasm Myelodysplastic Syndromes | Biological: human myeloid progenitor cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |

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:
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Experimental: Group B
Low dose, multiple donor CLT-008 (human myeloid progenitor cells)
|
Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
|
Experimental: Group C
Intermediate dose, multiple donor CLT-008 (human myeloid progenitor cells)
|
Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
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Experimental: Group D
High dose, multiple donor CLT-008 (human myeloid progenitor cells)
|
Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
|
- Safety and tolerability [ Time Frame: 100 days post transplant ]
- 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 ]

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Ages Eligible for Study: | 12 Years to 65 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891137
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 |
Principal Investigator: | John E Wagner, MD | University of Minnesota - Clinical and Translational Science Institute |
Additional Information:
Responsible Party: | Cellerant Therapeutics |
ClinicalTrials.gov Identifier: | NCT00891137 History of Changes |
Other Study ID Numbers: |
MT 2008-38 |
First Posted: | May 1, 2009 Key Record Dates |
Last Update Posted: | October 27, 2014 |
Last Verified: | October 2014 |
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:
Lymphoma Syndrome Leukemia Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Plasmacytoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Disease Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions |