Lymphoma, Non-HodgkinPhase 2TXA127-PBSCNCT01121120
Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients
A Phase 2 study testing TXA127 in people with Lymphoma, Non-Hodgkin and Hodgkin Disease, run by Tarix Pharmaceuticals at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma
- What is being tested?
- TXA127
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2010to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University
Atlanta, Georgia
University of Virginia Health System
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
City of Hope Hospital
Duarte, California, 91010
IU Simon Cancer Center
Indianapolis, Indiana, 46202
Stony Brook
Long Island City, New York
University of Nebraska Medical Center
Omaha, Nebraska
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Washington University
St Louis, Missouri
Montefiori Medical Center
The Bronx, New York, 10467
About this study
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
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.
Read the 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
- Conditions
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma
- Being tested
- TXA127, Placebo
- 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
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TXA127Drug
Also called Angiotensin 1-7
300mcg/kg/day, administered subcutaneously for up to 28 days
PlaceboDrug
300mcg/kg/day administered subcutaneously for up to 28 days
| Study group | Role | What they receive |
|---|---|---|
| TXA127 | Experimental | 300mcg/kg/day administered subcutaneously up to 28 days Receives: Drug: TXA127 |
| Placebo | Placebo comparator | 300mcg/kg/day administered subcutaneously up to 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ≤ 28 days from re-infusion of CD34+ cells
Safety of TXA127
Evaluate the safety of TXA127 administration following PBSC transplant
Measured: ≤ 28 days from re-infusion of CD34+ cells
Secondary outcomes (4)
Initial neutrophil recovery
Determine the effectiveness of TXA127 in accelerating the days to initial neutrophil recovery (ANCs > 0.5 x 10⁹/L)
Measured: ≤ 28 days from re-infusion of CD34+ cells
Mucositis
Evaluate the incidence of mucositis Grade 3/4
Measured: ≤ 28 days from re-infusion of CD34+ cells
Febrile neutropenia
Evaluate the effect of TXA127 in reducing the number of days of febrile neutropenia (fever and ANC <0.5 x 109/L)
Measured: ≤ 28 days from re-infusion of CD34+ cells
Platelet transfusions
Evaluate the effect of TXA127 in reducing the number of platelet transfusions needed
Measured: ≤ 28 days from re-infusion of CD34+ cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarix Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Constant Therapeutics LLC
- Responsible party
- Sponsor
- Investigators
- Michael Schuster, MD, Principal investigator, Stony Brook university Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121120
- Sponsor's protocol ID
- TXA127-2009-001
- Acronym
- TXA127-PBSC
- Status last verified
- Dec 2020
- First submitted
- 9 May 2010
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01121120
- Acronym / sponsor ID
- TXA127-PBSC / TXA127-2009-001
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tarix PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Constant Therapeutics LLC
- Study start
- Jun 2010
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA127 | Experimental | Drug: TXA127300mcg/kg/day administered subcutaneously up to 28 days |
| Placebo | Placebo comparator | Drug: Placebo300mcg/kg/day administered subcutaneously up to 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TXA127Also: Angiotensin 1-7300mcg/kg/day, administered subcutaneously for up to 28 days | Drug | TXA127 |
| Placebo300mcg/kg/day administered subcutaneously for up to 28 days | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
Initial neutrophil recovery
Time frame: ≤ 28 days from re-infusion of CD34+ cells
Mucositis
Time frame: ≤ 28 days from re-infusion of CD34+ cells
Febrile neutropenia
Time frame: ≤ 28 days from re-infusion of CD34+ cells
Platelet transfusions
Time frame: ≤ 28 days from re-infusion of CD34+ cells
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Schuster, MD principal investigator
Stony Brook university Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TXA127 in people with Lymphoma, Non-Hodgkin and Hodgkin Disease, run by Tarix Pharmaceuticals at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet recovery (time frame: ≤ 28 days from re-infusion of CD34+ cells). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.