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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Leukemia; Lymphoma; Multiple Myeloma; Plasma Cell Neoplasm; Myelodysplastic Syndromes	Biological: human myeloid progenitor cells	Phase 1

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: 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

Outcome Measures

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Primary Outcome Measures :

1. Safety and tolerability [ Time Frame: 100 days post transplant ]

Secondary Outcome Measures :

1. Neutrophil and platelet recovery [ Time Frame: 100 days post transplant ]
2. Persistence of CLT-008 derived cells [ Time Frame: 100 days post transplant ]
3. Graft-versus-host disease (GVHD) [ Time Frame: 100 days post transplant ]
4. Non-relapse mortality [ Time Frame: 100 days post transplant ]
5. Infections [ Time Frame: 42 days post transplant ]

Eligibility Criteria

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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

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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

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Additional Information:

Cellerant Therapeutics, Inc. 

Responsible Party:	Cellerant Therapeutics
ClinicalTrials.gov Identifier:	NCT00891137 History of Changes
Other Study ID Numbers:	MT 2008-38
First Posted:	May 1, 2009
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