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Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
This study has been completed.
Sponsor:
Cellerant Therapeutics
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
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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 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:
Genetics Home Reference related topics:
multiple myeloma
Genetic and Rare Diseases Information Center resources:
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
Myelodysplastic Syndromes
Chronic Lymphocytic Leukemia
Leukemia, B-cell, Chronic
Lymphosarcoma
Diffuse Large B-Cell Lymphoma
Waldenstrom Macroglobulinemia
Multiple Myeloma
Acute Lymphoblastic Leukemia
Childhood Acute Lymphoblastic Leukemia
B-cell Lymphoma
Burkitt Lymphoma
Follicular Lymphoma
Marginal Zone Lymphoma
Mantle Cell Lymphoma
Chronic Myeloid Leukemia
Lymphoma, Large-cell
Lymphoblastic Lymphoma
Plasmablastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
Anaplastic Plasmacytoma
U.S. FDA Resources
Further study details as provided by Cellerant Therapeutics:
Primary Outcome Measures:
- Safety and tolerability [ Time Frame: 100 days post transplant ]
Secondary Outcome Measures:
- 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 ]
| 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:
|
|
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:
|
|
Experimental: Group D
High dose, multiple donor CLT-008 (human myeloid progenitor cells)
|
Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
|
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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
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:
| 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 |
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 |
ClinicalTrials.gov processed this record on July 21, 2017