Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
This study is currently recruiting participants.
Verified April 2013 by Cellerant Therapeutics
Sponsor:
Cellerant Therapeutics
Collaborator:
Information provided by (Responsible Party):
Cellerant Therapeutics
ClinicalTrials.gov Identifier:
NCT00891137
First received: April 30, 2009
Last updated: April 16, 2013
Last verified: April 2013
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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 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:
MedlinePlus related topics:
Acute Myeloid Leukemia
Anemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | December 2013 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891137
Contacts
| Contact: Nancy Vinh | 650-232-5433 | nvinh@cellerant.com |
Locations
| United States, California | |
| University of California, San Diego | Recruiting |
| La Jolla, California, United States, 92037 | |
| Principal Investigator: Matthew Wieduwilt, MD, PhD | |
| Children's Hospital of Orange County | Recruiting |
| Orange, California, United States, 92868 | |
| Principal Investigator: Steven ML Neudorf, MD | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | Recruiting |
| Wilmington, Delaware, United States, 19803 | |
| Principal Investigator: E. Anders Kolb, MD | |
| United States, Illinois | |
| Loyola University Medical Center, Cardinal Bernardin Cancer Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Principal Investigator: Patrick J Stiff, MD | |
| United States, Minnesota | |
| University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: John E Wagner, MD | |
| United States, Ohio | |
| Cleveland Clinic, Taussig Cancer Institute | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: Brian T Hill, MD, PhD | |
| Case Western Reserve University, University Hospitals of Cleveland | Active, not recruiting |
| Cleveland, Ohio, United States, 44106 | |
Sponsors and Collaborators
Cellerant Therapeutics
Investigators
| Principal Investigator: | John E Wagner, MD | University of Minnesota - Clinical and Translational Science Institute |
More Information
Additional Information:
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: | April 16, 2013 |
| 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:
|
Neoplasms Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Lymphoma, Large-Cell, Immunoblastic Lymphoma, Non-Hodgkin Hematologic Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Neoplasms by Site |
ClinicalTrials.gov processed this record on May 23, 2013