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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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Two or more distinct types of malignant lymphoid tumors occurring within a single organ or tissue at the same time. It may contain different types of non-Hodgkin lymphoma cells or both Hodgkin and non-Hodgkin lymphoma cells.
A form of non-Hodgkin lymphoma having a usually diffuse pattern with both small and medium lymphocytes and small cleaved cells. It accounts for about 5% of adult non-Hodgkin lymphomas in the United States and Europe. The majority of mantle-cell lymphomas are associated with a t(11;14) translocation resulting in overexpression of the CYCLIN D1 gene (GENES, BCL-1).
Any of a group of malignant tumors of lymphoid tissue that differ from HODGKIN DISEASE, being more heterogeneous with respect to malignant cell lineage, clinical course, prognosis, and therapy. The only common feature among these tumors is the absence of giant REED-STERNBERG CELLS, a characteristic of Hodgkin's disease.
Clinically benign, histologically malignant, recurrent cutaneous T-cell lymphoproliferative disorder characterized by an infiltration of large atypical cells surrounded by inflammatory cells. The atypical cells resemble REED-STERNBERG CELLS of HODGKIN DISEASE or the malignant cells of CUTANEOUS T-CELL LYMPHOMA. In some cases, lymphomatoid papulosis progresses to lymphomatous conditions including MYCOSIS FUNGOIDES; HODGKIN DISEASE; CUTANEOUS T-CELL LYMPHOMA; or ANAPLASTIC LARGE-CELL LYMPHOMA.
A systemic, large-cell, non-Hodgkin, malignant lymphoma characterized by cells with pleomorphic appearance and expressing the CD30 ANTIGEN. These so-called "hallmark" cells have lobulated and indented nuclei. This lymphoma is often mistaken for metastatic carcinoma and MALIGNANT HISTIOCYTOSIS.
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