Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients
NCT ID: NCT01121120
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
75 participants
INTERVENTIONAL
2010-06-30
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* The conditioning regimen and mobilization agents used will be up to the discretion of the Study Center Investigator
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TXA127
300mcg/kg/day administered subcutaneously up to 28 days
TXA127
300mcg/kg/day, administered subcutaneously for up to 28 days
Placebo
300mcg/kg/day administered subcutaneously up to 28 days
Placebo
300mcg/kg/day administered subcutaneously for up to 28 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TXA127
300mcg/kg/day, administered subcutaneously for up to 28 days
Placebo
300mcg/kg/day administered subcutaneously for up to 28 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Constant Therapeutics LLC
INDUSTRY
Tarix Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Schuster, MD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook university Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope Hospital
Duarte, California, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
IU Simon Cancer Center
Indianapolis, Indiana, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Stony Brook
Long Island City, New York, United States
Montefiori Medical Center
The Bronx, New York, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TXA127-2009-001
Identifier Type: -
Identifier Source: org_study_id