Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Lymphoma, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/13/2018 |
Start Date: | June 2010 |
End Date: | September 2020 |
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
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.
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
study.
- The conditioning regimen and mobilization agents used will be up to the discretion of
the Study Center Investigator
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
We found this trial at
10
sites
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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