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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:
ClinicalTrials.gov Identifier:
NCT01121120
First Posted: May 12, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tarix Pharmaceuticals
May 9, 2010
May 12, 2010
October 12, 2017
June 2010
June 2018   (Final data collection date for primary outcome measure)
  • Platelet recovery [ Time Frame: ≤ 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 [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ]
    Evaluate the safety of TXA127 administration following PBSC transplant
Platelet recovery [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ]
Platelet recovery is defined as the day the subject achieves a post-nadir platelet count of ≥ 50 x 10⁹/L with no platelet transfusion in the prior 7 days.
Complete list of historical versions of study NCT01121120 on ClinicalTrials.gov Archive Site
  • Initial neutrophil recovery [ Time Frame: ≤ 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 [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ]
    Evaluate the incidence of mucositis Grade 3/4
  • Febrile neutropenia [ Time Frame: ≤ 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 [ Time Frame: ≤ 28 days from re-infusion of CD34+ cells ]
    Evaluate the effect of TXA127 in reducing the number of platelet transfusions needed
Initial neutrophil recovery [ Time Frame: ≤ 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)
Not Provided
Not Provided
 
Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients
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.
  • 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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
  • Multiple Myeloma
  • Drug: TXA127
    300mcg/kg/day, administered subcutaneously for up to 28 days
    Other Name: Angiotensin 1-7
  • Drug: Placebo
    300mcg/kg/day administered subcutaneously for up to 28 days
  • Experimental: TXA127
    300mcg/kg/day administered subcutaneously up to 28 days
    Intervention: Drug: TXA127
  • Placebo Comparator: Placebo
    300mcg/kg/day administered subcutaneously up to 28 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
September 2018
June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01121120
TXA127-2009-001
Yes
Not Provided
Not Provided
Tarix Pharmaceuticals
Tarix Pharmaceuticals
Not Provided
Principal Investigator: Michael Schuster, MD Stony Brook university Medical Center
Tarix Pharmaceuticals
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP