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

NCT01121120 | Terminated Phase 2 DMC

• 1 other identifier: TXA127-2009-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 10

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Initial neutrophil recovery

  ≤ 28 days from re-infusion of CD34+ cells

• Mucositis

  ≤ 28 days from re-infusion of CD34+ cells

• Febrile neutropenia

  ≤ 28 days from re-infusion of CD34+ cells

• Platelet transfusions

  ≤ 28 days from re-infusion of CD34+ cells

Study Arms (2)

TXA127

EXPERIMENTAL

300mcg/kg/day administered subcutaneously up to 28 days

Drug: TXA127

Placebo

PLACEBO COMPARATOR

300mcg/kg/day administered subcutaneously up to 28 days

Drug: Placebo

Interventions

TXA127 DRUG

300mcg/kg/day, administered subcutaneously for up to 28 days

Also known as: Angiotensin 1-7

TXA127

Placebo DRUG

300mcg/kg/day administered subcutaneously for up to 28 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarix Pharmaceuticals: lead
• Constant Therapeutics LLC: collaborator

Study Sites (10)

City of Hope Hospital

Duarte, California, 91010, United States

Location

Emory University

Atlanta, Georgia, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

IU Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Washington University

St Louis, Missouri, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, United States

Location

Stony Brook

Long Island City, New York, United States

Location

Montefiori Medical Center

The Bronx, New York, 10467, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Multiple Myeloma

Interventions

angiotensin I (1-7)

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Michael Schuster, MD

  Stony Brook university Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2010
• First Posted: May 12, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

US (10)