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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

Phase 2
18 Years
Open (Enrolling)
Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma

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Trial Information

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

- This is a randomized, double-blind (Investigator and Study Subject), placebo-controlled

- The conditioning regimen and mobilization agents used will be up to the discretion of
the Study Center Investigator

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Platelet recovery

Outcome Description:

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.

Outcome Time Frame:

≤ 28 days from re-infusion of CD34+ cells

Safety Issue:


Principal Investigator

Michael Schuster, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stony Brook university Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

June 2013

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
  • Multiple Myeloma
  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
  • Multiple myeloma
  • Peripheral Blood Stem Cell Transplant
  • Autologous Peripheral Blood Stem Cell Transplant
  • Limited re-infusion of CD34+ cells
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Huntsman Cancer Institute Salt Lake City, Utah  84112
Rush University Medical Center Chicago, Illinois  60612-3824
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Emory University Atlanta, Georgia  30322
Washington University St. Louis, Missouri  63110
IU Simon Cancer Center Indianapolis, Indiana  46202
University of Virginia Health System Charlottesville, Virginia  22903
City of Hope Hospital Duarte, California  91010
Montefiori Medical Center Bronx, New York  10467
Stony Brook Long Island, New York