Peripheral T Cell LymphomaPhase 1/2NCT05559008
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes
A Phase 1/2 study testing Azacitidine Injection, Dasatinib and Linperlisib in people with Peripheral T Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Azacitidine Injection, Dasatinib and Linperlisib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 26 Jan 2026
- Phase
- Phase 1/2
- 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
- Histologically-confirmed Peripheral T-cell lymphoma (without central nervous system involvement)
- Relapsed or refractory disease after first line treatment
- Availability of archival or freshly collected tumor tissue before study enrollment
- Evaluable lesion by PET-CT or CT scan
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life expectancy greater than or equal to (>/=) 3 months
- Informed consent
Who cannot join
- Patients with central nervous system (CNS) lymphoma
- History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
- Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
- Neutrophils<1.0×10^9/L Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
- Creatinine is 1.5 times higher than the ULN.
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- HIV-infected patients
- Active hepatitis infection
- Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
- Pregnant or lactation
- Other medical conditions determined by the researchers that may affect the study For T3.2 should exclude patiens with active autoimmune disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weili Zhao, M.D. and Ph.D, 13512112076, zhao.weili@yahoo.com
About this study
Official title: A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes
This is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Azacitidine Injection, Dasatinib, Linperlisib, Tucidinostat, SHR2554
- 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.
Azacitidine InjectionDrug
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
DasatinibDrug
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
LinperlisibDrug
Azacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes
TucidinostatDrug
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
SHR2554Drug
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
CamrelizumabDrug
Camrelizumab and Apatinib will be administered in T3.2 subtypes
ApatinibDrug
Camrelizumab and Apatinib will be administered in T3.2 subtypes
| Study group | Role | What they receive |
|---|---|---|
| T1 subtypes based on next generation sequencing results | Experimental | T1 subtypes based on next generation sequencing results Receives: Drug: Azacitidine Injection; Drug: Dasatinib |
| T2 subtypes based on next generation sequencing results | Experimental | T2 subtypes based on next generation sequencing results Receives: Drug: Azacitidine Injection; Drug: Linperlisib |
| T3.1 subtypes based on next generation sequencing results | Experimental | T3.1 subtypes based on next generation sequencing results Receives: Drug: Tucidinostat; Drug: SHR2554 |
| T3.2 subtypes based on next generation sequencing results | Experimental | T3.2 subtypes based on next generation sequencing results Receives: Drug: Camrelizumab; Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
Secondary outcomes (5)
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
Progression-free survival
Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Overall survival
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Duration of response
Duration of response was defined as the time from the date of favorable response until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria
Measured: Baseline up to data cut-off (up to approximately 2 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: From enrollment to study completion, a maximum of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start30 Sep 2022
- Primary completion26 Mar 2024 (estimated)
- Study completion26 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
- Investigators
- Weili Zhao, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559008
- Sponsor's protocol ID
- PTCL-IIT-umbrella
- Status last verified
- Nov 2022
- First submitted
- 25 Sep 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes
- ClinicalTrials.gov ID
- NCT05559008
- Acronym / sponsor ID
- PTCL-IIT-umbrella
- Conditions
- Peripheral T Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 26 Mar 2024 (estimated)
- Study completion
- 26 Jan 2026 (estimated)
- First posted
- 29 Sep 2022 (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, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T1 subtypes based on next generation sequencing results | Experimental | Drug: Azacitidine Injection, Drug: DasatinibT1 subtypes based on next generation sequencing results |
| T2 subtypes based on next generation sequencing results | Experimental | Drug: Azacitidine Injection, Drug: LinperlisibT2 subtypes based on next generation sequencing results |
| T3.1 subtypes based on next generation sequencing results | Experimental | Drug: Tucidinostat, Drug: SHR2554T3.1 subtypes based on next generation sequencing results |
| T3.2 subtypes based on next generation sequencing results | Experimental | Drug: Camrelizumab, Drug: ApatinibT3.2 subtypes based on next generation sequencing results |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically-confirmed Peripheral T-cell lymphoma (without central nervous system involvement)
- Relapsed or refractory disease after first line treatment
- Availability of archival or freshly collected tumor tissue before study enrollment
- Evaluable lesion by PET-CT or CT scan
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Key exclusion criteria (11 listed)
- Patients with central nervous system (CNS) lymphoma
- History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
- Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
- Neutrophils<1.0×10^9/L Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
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 |
|---|---|---|
| Azacitidine InjectionAzacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes | Drug | T1 subtypes based on next generation sequencing results, T2 subtypes based on next generation sequencing results |
| DasatinibAzacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes | Drug | T1 subtypes based on next generation sequencing results |
| LinperlisibAzacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes | Drug | T2 subtypes based on next generation sequencing results |
| TucidinostatTucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes | Drug | T3.1 subtypes based on next generation sequencing results |
| SHR2554Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes | Drug | T3.1 subtypes based on next generation sequencing results |
| CamrelizumabCamrelizumab and Apatinib will be administered in T3.2 subtypes | Drug | T3.2 subtypes based on next generation sequencing results |
| ApatinibCamrelizumab and Apatinib will be administered in T3.2 subtypes | Drug | T3.2 subtypes based on next generation sequencing results |
Primary outcome
Overall response rate
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
5 secondary outcomes
Complete response rate
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
Progression-free survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Overall survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Duration of response
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From enrollment to study completion, a maximum of 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Weili Zhao study chair
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Azacitidine Injection, Dasatinib and Linperlisib in people with Peripheral T Cell Lymphoma, run by Ruijin 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 9 Nov 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao (+862164370045 ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)). 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 9 Nov 2022.