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

Multiple Myeloma Clinical Trial

— TXA127-PBSC  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01121120
• Other study ID #: TXA127-2009-001
• Status: Terminated
• Phase: Phase 2
• Start date: June 2010
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: Tarix Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• TXA127
300mcg/kg/day, administered subcutaneously for up to 28 days
• Placebo
300mcg/kg/day administered subcutaneously for up to 28 days

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Montefiori Medical Center	Bronx	New York
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	City of Hope Hospital	Duarte	California
United States	IU Simon Cancer Center	Indianapolis	Indiana
United States	Stony Brook	Long Island City	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Washington University	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Tarix Pharmaceuticals	Constant Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet recovery	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.	= 28 days from re-infusion of CD34+ cells
Primary	Safety of TXA127	Evaluate the safety of TXA127 administration following PBSC transplant	= 28 days from re-infusion of CD34+ cells
Secondary	Initial neutrophil recovery	Determine the effectiveness of TXA127 in accelerating the days to initial neutrophil recovery (ANCs > 0.5 x 10?/L)	= 28 days from re-infusion of CD34+ cells
Secondary	Mucositis	Evaluate the incidence of mucositis Grade 3/4	= 28 days from re-infusion of CD34+ cells
Secondary	Febrile neutropenia	Evaluate the effect of TXA127 in reducing the number of days of febrile neutropenia (fever and ANC <0.5 x 109/L)	= 28 days from re-infusion of CD34+ cells
Secondary	Platelet transfusions	Evaluate the effect of TXA127 in reducing the number of platelet transfusions needed	= 28 days from re-infusion of CD34+ cells