Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients (TXA127-PBSC)

Tarix Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Multiple Myeloma

Hodgkin Disease

Lymphoma, Non-Hodgkin

Treatments

Drug: Placebo

Drug: TXA127

Study type

Interventional

Funder types

Industry

Identifiers

NCT01121120

TXA127-2009-001

Details and patient eligibility

About

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.

Full 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

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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