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| ID | Type | Description | Link |
|---|---|---|---|
| POL-4 | Other Identifier | Polyphor |
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Determine the safety and tolerability of POL6326 when used as a single mobilization agent.
Current protocols use G-CSF to mobilize hematopoietic progenitor cells from matched sibling donors. This process requires from four to six days of G-CSF injection and is associated with significant morbidity, most notably bone pain. POL6326 is associated with few side effects and collection of cells occurs on the same day as POL6326 administration.
This study will evaluate the safety and efficacy of this novel agent for hematopoietic progenitor cell mobilization and allogeneic transplantation based on the following hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donor (Phase I and Phase II) | Experimental | On Day 1 (and possibly Day 2) POL6326 IV Infusion with increasing dose levels in Phase I or with random dose assignment (from the 2 selected from Phase I) in phase II Leukapheresis collection on Day 1 (and possibly Day 2) |
|
| Recipient | Experimental | Day 0 - PBSC transplant with stem cells mobilized with IV POL6326 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POL6326 | Drug |
| ||
| Leukapheresis |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I Study - safety and tolerability of POL6326 as a mobilization agent. | 30 days | |
| Phase II Study - determine the number of allogeneic donors who require a second leukapheresis | Determine the number of allogeneic donors which collect >= 2 mill CD34+ cells with one or two leukapheresis procedures treated with IV POL6326. Comparison with historic group of donors who were mobilized with 240 µg/kg SC plerixafor. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I Study - define maximum tolerated dose of POL6326 | 30 days | |
| Phase II Study - the proportion of HLA-identical sibling donors who experience grade 3-4 infusional toxicity and the proportion who are safely mobilized | To estimate the proportion of HLA-identical sibling donors who experience grade 3-4 infusional toxicity and the proportion from whom > 2 mill CD34+ cells/kg recipient weight are safely mobilized following one or two leukapheresis procedures |
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Donor Inclusion Criteria
Recipient Inclusion Criteria
Donor Exclusion Criteria
Recipient Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Couriel, M.D. | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Cancer Center | Kansas City | Kansas | 66205 | United States | ||
| Washington University School of Medicine |
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|
| PBSC Transplant | Procedure |
|
| 30 days |
| Phase II Study - pharmacokinetics and pharmacodynamics of IV POL6326 | Stem cell and T-cell phenotyping | Day 1-3 |
| Phase II Study - rate of acute GVHD and chronic GVHD in patients who receive IV POL6326 mobilized peripheral blood stem cells. | Acute GVHD - Day 100 (+/- 7 days) Chronic GVHD - Day 365 (+/- 14 days) | Day 100 (+/- 7 days) or Day 365 (+/-14 days) |
| Phase II Study - kinetics of neutrophil and platelet engraftment in recipients of POL6326 mobilized peripheral blood stem cells. | Day 365 (+/- 14 days) |
| St Louis |
| Missouri |
| 63110 |
| United States |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009101 | Multiple Myeloma |
| D009190 | Myelodysplastic Syndromes |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| C000624271 | balixafortide |
| D007937 | Leukapheresis |
| ID | Term |
|---|---|
| D016238 | Cytapheresis |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001781 | Blood Component Removal |
| D047589 | Leukocyte Reduction Procedures |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
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