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

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.

Study Overview

• Status: Terminated
• Conditions: Lymphoma, Non-Hodgkin; Multiple Myeloma; Hodgkin Disease
• Intervention / Treatment: Drug: TXA127; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Hospital
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Simon Cancer Center
  • Missouri
    • Saint Louis, Missouri, United States
      • Washington University
  • Nebraska
    • Omaha, Nebraska, United States
      • University of Nebraska Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiori Medical Center
    • Long Island City, New York, United States
      • Stony brook
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TXA127; 300mcg/kg/day administered subcutaneously up to 28 days	Drug: TXA127; 300mcg/kg/day, administered subcutaneously for up to 28 days; Other Names: Angiotensin 1-7
Placebo Comparator: Placebo; 300mcg/kg/day administered subcutaneously up to 28 days	Drug: Placebo; 300mcg/kg/day administered subcutaneously for up to 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Safety of TXA127	Evaluate the safety of TXA127 administration following PBSC transplant	≤ 28 days from re-infusion of CD34+ cells

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial neutrophil recovery	Determine the effectiveness of TXA127 in accelerating the days to initial neutrophil recovery (ANCs > 0.5 x 10⁹/L)	≤ 28 days from re-infusion of CD34+ cells
Mucositis	Evaluate the incidence of mucositis Grade 3/4	≤ 28 days from re-infusion of CD34+ cells
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
Platelet transfusions	Evaluate the effect of TXA127 in reducing the number of platelet transfusions needed	≤ 28 days from re-infusion of CD34+ cells

Collaborators and Investigators

• Sponsor: Tarix Pharmaceuticals
• Collaborators: Constant Therapeutics LLC
• Investigators: Principal Investigator: Michael Schuster, MD, Stony Brook University Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: May 9, 2010
• First Submitted That Met QC Criteria: May 9, 2010
• First Posted (Estimate): May 12, 2010

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Multiple myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Peripheral Blood Stem Cell Transplant; Autologous Peripheral Blood Stem Cell Transplant; Limited re-infusion of CD34+ cells
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Hodgkin Disease; Lymphoma, Non-Hodgkin; Antihypertensive Agents; Vasodilator Agents; Angiotensin I (1-7)
• Other Study ID Numbers: TXA127-2009-001