Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients (TXA127-PBSC)
This study is ongoing, but not recruiting participants.
Sponsor:
US Biotest, Inc.
Collaborator:
Tarix Pharmaceuticals
Information provided by (Responsible Party):
US Biotest, Inc.
ClinicalTrials.gov Identifier:
NCT01121120
First received: May 9, 2010
Last updated: March 25, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Non-Hodgkin Hodgkin Disease Multiple Myeloma |
Drug: TXA127 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Phase II Study Evaluating the Safety and Efficacy of TXA127 in the Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Hodgkin Lymphoma, Non-Hodgkin Lymphoma or Multiple Myeloma Undergoing Limited Reinfusion of CD34+ Cells |
Resource links provided by NLM:
Further study details as provided by US Biotest, Inc.:
Primary Outcome Measures:
- Platelet recovery [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: Yes ]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.
- Safety of TXA127 [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: Yes ]Evaluate the safety of TXA127 administration following PBSC transplant
Secondary Outcome Measures:
- Initial neutrophil recovery [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: Yes ]Determine the effectiveness of TXA127 in accelerating the days to initial neutrophil recovery (ANCs > 0.5 x 10⁹/L)
- Mucositis [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: No ]Evaluate the incidence of mucositis Grade 3/4
- Febrile neutropenia [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: No ]Evaluate the effect of TXA127 in reducing the number of days of febrile neutropenia (fever and ANC <0.5 x 109/L)
- Platelet transfusions [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: No ]Evaluate the effect of TXA127 in reducing the number of platelet transfusions needed
| Estimated Enrollment: | 74 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TXA127
300mcg/kg/day administered subcutaneously up to 28 days
|
Drug: TXA127
300mcg/kg/day, administered subcutaneously for up to 28 days
Other Name: Angiotensin 1-7
|
|
Placebo Comparator: Placebo
300mcg/kg/day administered subcutaneously up to 28 days
|
Drug: Placebo
300mcg/kg/day administered subcutaneously for up to 28 days
Other Name: Placebo
|
Detailed Description:
- This is a randomized, double-blind (Investigator and Study Subject), placebo-controlled study.
- The conditioning regimen and mobilization agents used will be up to the discretion of the Study Center Investigator
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- Use of an effective contraceptive method during the course of the study and for 2 months following the last administration of Investigational Product
- Female subjects capable of reproduction must have a negative beta human chorionic gonadotropin (BHCG) serum or urine pregnancy test result within 7 days prior to first Investigational Product dose
- Female subjects who are surgically sterilized or who have not experienced menses for at least two years are not required to have a pregnancy test
Exclusion Criteria:
- Subjects who have received radiotherapy to the pelvis and/or sternum within one year of first Investigational Product administration
- Subjects who have previously received or have planned Total Body Irradiation (TBI)
- Subjects with a history of prior malignancy other than HL, NHL, or MM that have not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma, cervical carcinoma in situ on biopsy, or localized prostate cancer (Gleason score <5)
- Subjects with a history of myelodysplastic syndrome
- Subjects who have had a venous or arterial embolic event AND who have received anti-coagulant treatment, where both the event and the treatment were within six months of the first Investigational Product administration
- Prior allogeneic hematopoietic cell transplant
- Presence of an uncontrolled infection or infection that required intravenous treatment within 7 days of entry
- Female subjects who are pregnant or breastfeeding
- Subjects who have received treatment with an investigational agent within 30 days of the projected first administration of Investigational Product (Day 0)
- Subjects with current alcohol use, illicit drug use, or any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule
- Subjects with a known sensitivity to any of the Investigational Product components
- Subjects known to be seropositive for HIV or for HTLV-I
- Subjects for whom prophylactic platelet transfusions, at platelet counts >10× 109/L, are anticipated following PBSC transplant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121120
Locations
| United States, California | |
| City of Hope Hospital | |
| Duarte, California, United States, 91010 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| IU Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Missouri | |
| Washington University | |
| St Louis, Missouri, United States | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States | |
| United States, New York | |
| Montefiori Medical Center | |
| Bronx, New York, United States, 10467 | |
| Stony Brook | |
| Long Island, New York, United States | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
Sponsors and Collaborators
US Biotest, Inc.
Tarix Pharmaceuticals
Investigators
| Principal Investigator: | Michael Schuster, MD | Stony Brook university Medical Center |
More Information
No publications provided
| Responsible Party: | US Biotest, Inc. |
| ClinicalTrials.gov Identifier: | NCT01121120 History of Changes |
| Other Study ID Numbers: | TXA127-2009-001 |
| Study First Received: | May 9, 2010 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by US Biotest, Inc.:
|
Lymphoma, Non-Hodgkin Hodgkin Disease Multiple myeloma |
Peripheral Blood Stem Cell Transplant Autologous Peripheral Blood Stem Cell Transplant Limited re-infusion of CD34+ cells |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on June 18, 2013