Hodgkin Disease, Lymphoma, Non-Hodgkin, Multiple Myeloma
Conditions
Keywords
Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple myeloma, Peripheral Blood Stem Cell Transplant, Autologous Peripheral Blood Stem Cell Transplant, Limited re-infusion of CD34+ cells
Brief 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.
Detailed 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
Interventions
DRUGTXA127
300mcg/kg/day, administered subcutaneously for up to 28 days
DRUGPlacebo
300mcg/kg/day administered subcutaneously for up to 28 days
Sponsors
Constant Therapeutics LLC
Tarix Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet recovery | ≤ 28 days from re-infusion of CD34+ cells | Evaluate the effectiveness of TXA127 in accelerating the time to initial platelet recovery following PBSC transplant with a limited number of CD34+ cells, defined as CD34+ cell concentrations ≥1.5 x 106 and ≤5.0 x 106 CD34+ cells/kg. Platelet recovery is defined as that day the subject achieves a post-nadir platelet count of ≥20 x 109/L with no platelet transfusion in the prior 7 days. |
| Safety of TXA127 | ≤ 28 days from re-infusion of CD34+ cells | Evaluate the safety of TXA127 administration following PBSC transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial neutrophil recovery | ≤ 28 days from re-infusion of CD34+ cells | Determine the effectiveness of TXA127 in accelerating the days to initial neutrophil recovery (ANCs \> 0.5 x 10⁹/L) |
| Mucositis | ≤ 28 days from re-infusion of CD34+ cells | Evaluate the incidence of mucositis Grade 3/4 |
| Febrile neutropenia | ≤ 28 days from re-infusion of CD34+ cells | Evaluate the effect of TXA127 in reducing the number of days of febrile neutropenia (fever and ANC \<0.5 x 109/L) |
| Platelet transfusions | ≤ 28 days from re-infusion of CD34+ cells | Evaluate the effect of TXA127 in reducing the number of platelet transfusions needed |
Countries
United States
Outcome results
None listed