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This is an open-label, multicenter, prospective pilot study of CDX-301 with or without plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from another person). HLA-matched sibling healthy volunteers (donors) and patients with protocol specified hematologic malignancies (recipients) will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDX-301 | Experimental |
| |
| CDX-301 and plerixafor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDX-301 | Drug | Related donors will receive CDX-301 for 5 days or 7 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability profile of CDX-301 with or without plerixafor in healthy adult sibling stem cell donors. | Safety and tolerability will be evaluated by comparing the treatment regimens in regards to vital sign measurements, physical examinations and adverse event reporting. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of donors whose stem cells can be successfully mobilized and collected with a sufficient CD34+ cell count using CDX-301 with or without plerixafor as the mobilizing agent. | Donor mobilization will be considered successful if ≥ 2 million CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections. | Day 6 - Day 12 |
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Inclusion Criteria:
Donors:
Recipient:
Diagnosis of one of following:
Exclusion Criteria:
Donors:
Recipient:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| Emory University-Winship Cancer Institute |
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| CDX-301 and plerixafor |
| Drug |
Related donors will receive CDX-301 for 5 or 7 days plus plerixafor. |
|
| Describe the cellular composition of allografts mobilized with CDX-301 with or without plerixafor (stem/progenitor cells, T/B/NK-cells). | To describe the cellular composition of allografts mobilized with CDX-301 with or without plerixafor (stem/progenitor cells, T/B/NK-cells). | Day 6 - Day 12 |
| Incidence of and kinetics of neutrophil and platelet recovery after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor | To determine the incidence of and kinetics of neutrophil, and platelet recovery after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor. | Day 21, Day 28, Day 56, Day 100, Day 180, Day 270, Day 365. |
| Incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with CDX301-03 with or without plerixafor. | To determine the incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor. | Day 28, Day 100, Day 180, Day 365. |
| Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor. | To assess the rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor. | Day 28, 100, 180, 365. |
| Incidence of acute and chronic graft-versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor. | To determine the incidence of acute and chronic graft-versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor. | Day 28, Day 56, Day 100, Day 180, Day 270, Day 365. |
| Incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor in transplant recipients. | To determine the incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor in transplant recipients. | Day 28, Day 56, Day 100, Day 180, Day 270, Day 365. |
| Number of post-transplant days of hospitalization in patients that received hematopoietic cells mobilized with CDX-301 with or without plerixafor. | To determine the number of post transplant days of hospitalization after receiving hematopoietic cells mobilized with CDX-301 with or without plerixafor. | Day 21, 28, 56, 100, 180, 270, 365 |
| Incidence of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor. | To determine the incidence of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor. | Day 21, 28, 56, 100, 180, 270, 365. |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Indiana Blood and Marrow Transplant | Indianapolis | Indiana | 46237 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute | Columbus | Ohio | 43210 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D015448 | Leukemia, B-Cell |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
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