Relapsed Peripheral T-Cell LymphomaNCT06671717
Pralatrexate Combined With Chidamide Bridging Allogeneic HSCT for Refractory/Relapsed Peripheral T-cell Lymphoma
A study testing Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation in people with Relapsed Peripheral T-Cell Lymphoma and Refractory Peripheral T-Cell Lymphoma, run by Peking University People's Hospital at 1 site in China.
Trial summary
This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsed Peripheral T-Cell Lymphoma, Refractory Peripheral T-Cell Lymphoma
- What is being tested?
- Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fully understand the study, voluntarily participate in and sign on the informed consent;
- Diagnosed by histopathology Peripheral T-cell lymphoma;
- ECOG PS score 0 or 1;
- Relapsed or Refractory Peripheral T Cell Lymphoma；
- According to the 2014 version of the Lugano criteria for lymphoma, there must be at least one CT/MRI measurable lesion (measurable lymph node diameter>1.5cm; measurable extranodal lesion diameter>1.0cm)；
- Provided a written pathological/histological diagnosis report during the screening period and agreed to provide tumor tissue sections or tumor/lymph node tissue specimens for testing at the central laboratory;
- Expected survival at least 12 weeks；
- Agreed to receive treatment with Pralatrexate
Who cannot join
- NK/T-cell lymphoma;
- Achieving CR or PR after induction chemotherapies without relapse;
- Dysfunction of vital organs;
- Serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases; Or have a history of organ transplantation;
- Unwilling to accept allogeneic hematopoietic stem cell transplantation;
- Undergoing other clinical studies within a month;
- Without donor for transplantation;
- Allergies to similar drugs and excipients of the research drug
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University, Institute of Hematolgoy, Beijing,
Beijing
Xiaodong Mo
About this study
Official title: Pralatrexate Combined With Chidamide Bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma
This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma
- Being tested
- Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation
- Keywords
- Allogeneic hematopoietic stem cell transplantation, Pralatrexate, Remission status before transplantation
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell TransplantationOther
Drug: Pralatrexate, Chidamide
- Pralatrexate: 30 mg/m2 intravenously (IV) administered weekly in 6-week cycles. Chidamide: 20mg, twice a week in 3-week cycles (2 weeks on treatment, 1 week off treatment)
- After the 6-week therapy, the patients should receive PET/CT evaluation.
- Patients would receive allo-HSCT if they could achieve at least PR after the first cycle of therapy. For the patients could not achieve a least PR after the first cycle of therapy, they should receive a second cycle of pralatrexate combined with chidamide. The interval between two cycles of pralatrexate combined with chidamide should be at least 1 week.
- After the second cycle of 6-week therapy, the patients should receive PET/CT evaluation. Patients would receive allo-HSCT if they could achieve at least SD after the second cycle of therapy. For the patients could not achieve a least SD after the second cycle of therapy, they should receive other salvage therapies.
| Study group | Role | What they receive |
|---|---|---|
| Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patients | Experimental | Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patients Receives: Other: Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) at 1 year after transplantation
The time from the end of transplantation to progression of disease or death at 1year
Measured: Participants will be followed for an expected average of 1 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Peripheral T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Wuhan TongJi Hospital, West China Hospital
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Xiaodong Mo, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671717
- Sponsor's protocol ID
- PUPH-PTCL-001
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pralatrexate Combined With Chidamide Bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06671717
- Acronym / sponsor ID
- PUPH-PTCL-001
- Keywords
- Allogeneic hematopoietic stem cell transplantation, Pralatrexate, Remission status before transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Wuhan TongJi Hospital, West China Hospital
- Study start
- Dec 2024 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 Nov 2024 (actual)
- 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.
This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patients | Experimental | Other: Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell TransplantationPralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients fully understand the study, voluntarily participate in and sign on the informed consent;
- Diagnosed by histopathology Peripheral T-cell lymphoma;
- ECOG PS score 0 or 1;
- Relapsed or Refractory Peripheral T Cell Lymphoma；
- According to the 2014 version of the Lugano criteria for lymphoma, there must be at least one CT/MRI measurable lesion (measurable lymph node diameter>1.5cm; measurable extranodal lesion diameter>1.0cm)；
Key exclusion criteria (8 listed)
- NK/T-cell lymphoma;
- Achieving CR or PR after induction chemotherapies without relapse;
- Dysfunction of vital organs;
- Serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases; Or have a history of organ transplantation;
- Unwilling to accept allogeneic hematopoietic stem cell transplantation;
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 |
|---|---|---|
| Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell TransplantationDrug: Pralatrexate, Chidamide 1. Pralatrexate: 30 mg/m2 intravenously (IV) administered weekly in 6-week cycles. Chidamide: 20mg, twice a week in 3-week cycles (2 weeks on treatment, 1 week off treatment) 2. After the 6-week therapy, the patients should receive PET/CT evaluation. 3. Patients would receive allo-HSCT if they could achieve at least PR after the first cycle of therapy. For the patients could not achieve a least PR after the first cycle of therapy, they should receive a second cycle of pralatrexate combined with chidamide. The interval between two cycles of pralatrexate combined with chidamide should be at least 1 week. 4. After the second cycle of 6-week therapy, the patients should receive PET/CT evaluation. Patients would receive allo-HSCT if they could achieve at least SD after the second cycle of therapy. For the patients could not achieve a least SD after the second cycle of therapy, they should receive other salvage therapies. | Other | Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patients |
Primary outcome
Progression-free survival (PFS) at 1 year after transplantation
Time frame: Participants will be followed for an expected average of 1 years after transplantation
The time from the end of transplantation to progression of disease or death at 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
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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.
Xiaodong Mo principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation in people with Relapsed Peripheral T-Cell Lymphoma and Refractory Peripheral T-Cell Lymphoma, run by Peking University People's Hospital at 1 site in China.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Mo, MD (8610-8832-6001, mxd453@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) at 1 year after transplantation (time frame: Participants will be followed for an expected average of 1 years after transplantation). 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 6 Nov 2024.