Trial record 1 of 1 for:    NCT01121120
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Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients (TXA127-PBSC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tarix Pharmaceuticals
Information provided by (Responsible Party):
US Biotest, Inc.
ClinicalTrials.gov Identifier:
NCT01121120
First received: May 9, 2010
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Hodgkin Disease
Multiple Myeloma
Drug: TXA127
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by US Biotest, Inc.:

Primary Outcome Measures:
  • Platelet recovery [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: Yes ]
    Evaluate the safety of TXA127 administration following PBSC transplant


Secondary Outcome Measures:
  • Initial neutrophil recovery [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: Yes ]
    Determine the effectiveness of TXA127 in accelerating the days to initial neutrophil recovery (ANCs > 0.5 x 10⁹/L)

  • Mucositis [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: No ]
    Evaluate the incidence of mucositis Grade 3/4

  • Febrile neutropenia [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: No ]
    Evaluate the effect of TXA127 in reducing the number of days of febrile neutropenia (fever and ANC <0.5 x 109/L)

  • Platelet transfusions [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ] [ Designated as safety issue: No ]
    Evaluate the effect of TXA127 in reducing the number of platelet transfusions needed


Estimated Enrollment: 74
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TXA127
300mcg/kg/day administered subcutaneously up to 28 days
Drug: TXA127
300mcg/kg/day, administered subcutaneously for up to 28 days
Other Name: 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
Other Name: 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121120

Locations
United States, California
City of Hope Hospital
Duarte, California, United States, 91010
United States, Georgia
Emory University
Atlanta, Georgia, United States
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Missouri
Washington University
St Louis, Missouri, United States
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States
United States, New York
Montefiori Medical Center
Bronx, New York, United States, 10467
Stony Brook
Long Island, New York, United States
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
US Biotest, Inc.
Tarix Pharmaceuticals
Investigators
Principal Investigator: Michael Schuster, MD Stony Brook university Medical Center
  More Information

No publications provided

Responsible Party: US Biotest, Inc.
ClinicalTrials.gov Identifier: NCT01121120     History of Changes
Other Study ID Numbers: TXA127-2009-001
Study First Received: May 9, 2010
Last Updated: March 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by US Biotest, Inc.:
Lymphoma, Non-Hodgkin
Hodgkin Disease
Multiple myeloma
Peripheral Blood Stem Cell Transplant
Autologous Peripheral Blood Stem Cell Transplant
Limited re-infusion of CD34+ cells

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on August 21, 2014