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| Name | Class |
|---|---|
| Constant Therapeutics LLC | INDUSTRY |
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The purpose of this study is to determine the safety and effectiveness of TXA127 in accelerating the time it takes for patients to recover their platelet counts following a Autologous Peripheral Blood Stem Cell transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TXA127 | Experimental | 300mcg/kg/day administered subcutaneously up to 28 days |
|
| Placebo | Placebo Comparator | 300mcg/kg/day administered subcutaneously up to 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TXA127 | Drug | 300mcg/kg/day, administered subcutaneously for up to 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Platelet recovery | Evaluate the effectiveness of TXA127 in accelerating the time to initial platelet recovery following PBSC transplant with a limited number of CD34+ cells, defined as CD34+ cell concentrations ≥1.5 x 106 and ≤5.0 x 106 CD34+ cells/kg. Platelet recovery is defined as that day the subject achieves a post-nadir platelet count of ≥20 x 109/L with no platelet transfusion in the prior 7 days. | ≤ 28 days from re-infusion of CD34+ cells |
| Safety of TXA127 | Evaluate the safety of TXA127 administration following PBSC transplant | ≤ 28 days from re-infusion of CD34+ cells |
| Measure | Description | Time Frame |
|---|---|---|
| Initial neutrophil recovery | Determine the effectiveness of TXA127 in accelerating the days to initial neutrophil recovery (ANCs > 0.5 x 10⁹/L) | ≤ 28 days from re-infusion of CD34+ cells |
| Mucositis |
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Inclusion Criteria:
Subjects must be at least 18 years of age
Subjects must have HL, NHL, or MM requiring PBSCT
Subjects must have a life expectancy of at least 4 months
Subjects are to receive autologous PBSC transplant following mobilization, CD34+ cells collected by apheresis, and conditioning chemotherapy
Subjects must give written informed consent to participate in study. Consent must be obtained prior to the performance of any study-specific, non-institutional standard procedures. A copy of the signed informed consent will be retained in the subject's chart.
Subjects must have CD34+ collection which allows reinfusion of ≥1.5 x 106 and ≤5.0 x 106 CD34+ cells/kg
Subjects must have a psychological and emotional state that, in the view of the investigators, allows adherence to the protocol
Female subjects capable of reproduction, and male subjects who have partners capable of reproduction, must agree to the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Schuster, MD | Stony Brook university Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Hospital | Duarte | California | 91010 | United States | ||
| Emory University |
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| Placebo | Drug | 300mcg/kg/day administered subcutaneously for up to 28 days |
|
Evaluate the incidence of mucositis Grade 3/4
| ≤ 28 days from re-infusion of CD34+ cells |
| Febrile neutropenia | Evaluate the effect of TXA127 in reducing the number of days of febrile neutropenia (fever and ANC <0.5 x 109/L) | ≤ 28 days from re-infusion of CD34+ cells |
| Platelet transfusions | Evaluate the effect of TXA127 in reducing the number of platelet transfusions needed | ≤ 28 days from re-infusion of CD34+ cells |
| Atlanta |
| Georgia |
| United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| IU Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Washington University | St Louis | Missouri | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | United States |
| Stony Brook | Long Island City | New York | United States |
| Montefiori Medical Center | The Bronx | New York | 10467 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| C118790 | angiotensin I (1-7) |
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