Overview

This trial is active, not recruiting.

Conditions lymphoma, non-hodgkin, hodgkin disease, multiple myeloma
Treatments txa127, placebo
Phase phase 2
Sponsor Tarix Pharmaceuticals
Start date June 2010
End date June 2017
Trial size 75 participants
Trial identifier NCT01121120, TXA127-2009-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose supportive care
Arm
(Experimental)
300mcg/kg/day administered subcutaneously up to 28 days
txa127 Angiotensin 1-7
300mcg/kg/day, administered subcutaneously for up to 28 days
(Placebo Comparator)
300mcg/kg/day administered subcutaneously up to 28 days
placebo
300mcg/kg/day administered subcutaneously for up to 28 days

Primary Outcomes

Measure
Platelet recovery
time frame: ≤ 28 days from re-infusion of CD34+ cells
Safety of TXA127
time frame: ≤ 28 days from re-infusion of CD34+ cells

Secondary Outcomes

Measure
Initial neutrophil recovery
time frame: ≤ 28 days from re-infusion of CD34+ cells
Mucositis
time frame: ≤ 28 days from re-infusion of CD34+ cells
Febrile neutropenia
time frame: ≤ 28 days from re-infusion of CD34+ cells
Platelet transfusions
time frame: ≤ 28 days from re-infusion of CD34+ cells

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Michael Schuster, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Tarix Pharmaceuticals.
Location data was received from the National Cancer Institute and was last updated in August 2016.