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Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin and Non-Hodgkin Lymphoma Patients

2014-08-27 03:13:47 | BioPortfolio

Summary

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.

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

Key Eligibility Criteria:

Inclusion:

- 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

Exclusion:

- 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

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Conditions

Lymphoma, Non-Hodgkin

Intervention

TXA127, Placebo

Location

Emory University
Atlanta
Georgia
United States
60612

Status

Not yet recruiting

Source

US Biotest, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:47-0400

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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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