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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.
- 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
Key Eligibility Criteria:
- Subjects are ≥ 18 years of age
- Subjects have recurrent NHL or HL requiring PBSCT
- Subjects to receive autologous PBSCT following conditioning chemotherapy, mobilization, and PBSC collected by apheresis
- Subjects have ECOG performance status of 0-1
- Subjects have life expectancy of ≥ 4 months
- Subjects have CD34+ collection of ≥ 1.5 x 10⁶ and ≥ 5.0 x 10⁶ CD34+ cells/kg
- Subjects who have received radiotherapy to pelvic or abdominal region within 1 year of study entry
- Subjects with history of or plan to have Total Body Irradiation (TBI)
- Subjects with history of prior malignancy other than HL or NHL that have not been in remission > 5 years except basal cell, squamous cell carcinoma, cervical carcinoma in situ on biopsy or localized prostate cancer (Gleason score <5)
- Subjects with history of Myelodysplastic Syndrome
- Prior allogeneic or autologous hemapoietic cell transplant
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Not yet recruiting
US Biotest, Inc.
Published on BioPortfolio: 2014-08-27T03:13:47-0400
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