Clinical trial NCT01121120: Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Hodgkin Disease
Multiple Myeloma
Keywords: Lymphoma, Non-Hodgkin
Hodgkin Disease
Multiple myeloma
Peripheral Blood Stem Cell Transplant
Autologous Peripheral Blood Stem Cell Transplant
Limited re-infusion of CD34+ cells
Lead sponsor: Tarix Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Constant Therapeutics LLC
First posted: 2010-05-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: Platelet recovery
timeFrame: ≤ 28 days from re-infusion of CD34+ cells
measure: Safety of TXA127
timeFrame: ≤ 28 days from re-infusion of CD34+ cells
Secondary outcomes:
measure: Initial neutrophil recovery
timeFrame: ≤ 28 days from re-infusion of CD34+ cells
measure: Mucositis
timeFrame: ≤ 28 days from re-infusion of CD34+ cells
measure: Febrile neutropenia
timeFrame: ≤ 28 days from re-infusion of CD34+ cells
measure: Platelet transfusions
timeFrame: ≤ 28 days from re-infusion of CD34+ cells
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Hospital
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: IU Simon Cancer Center
state: Indiana
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Bronx
country: United States
facility: Montefiori Medical Center
state: New York
city: Long Island City
country: United States
facility: Stony Brook
state: New York
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: Stony Brook university Medical Center
name: Michael Schuster, MD
role: PRINCIPAL_INVESTIGATOR
References: