Non-hodgkin Lymphoma,B CellPhase 1/2NCT04897477
Azacytidine, Bendamustine, Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma
A Phase 1/2 study testing Azacytidine, Bendamustine and Piamprizumab in people with Non-hodgkin Lymphoma,B Cell, run by Chinese PLA General Hospital at 2 sites in China.
Trial summary
This is an open label, single arm, phase I/II for patients with r/r Non-Hodgkin's Lymphoma . The purpose is to evaluate the safety and efficacy of the combination with Azacytidine, Bendamustine and Piamprizumab Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-hodgkin Lymphoma,B Cell
- What is being tested?
- Azacytidine, Bendamustine and Piamprizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 22 Apr 2021to 23 Apr 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤80 years
- Performance status (ECOG) between 0 and 3.
- Histologically confirmed B-cell non-Hodgkin lymphoma (NHL), including the following types defined by WHO 2016.
- Refractory disease or relapsed after treatment with ≥2 lines of chemotherapy and either having failed autologous HSCT or being ineligible for or not consenting to autologous HSCT; or not suitable for CAR T treatment or resistance, progression or relapse after CAR T treatment; or CAR T pre-culturing losers can also be enrolled.
- Adequate organ function.
- An adequate bone marrow reserve.
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- Measurable or assessable disease according to the"IWG Response Criteria for Malignant Lymphoma"(Cheson 2014). Patients in complete remission (CR) with no evidence of disease were not eligible.
- Informed consent/assent requiring that all patients have the ability to understand and the willingness to provide written informed consent.
- Life expectancy > 12 weeks.
- Patients with definite involvement of the gastrointestinal tract, and patients with central nervous system (CNS) by PETCT and MRI involvement were allowed to enrolled in this clinical study.
Who cannot join
- Pregnant or lactating women.
- Uncontrolled medical disorders, active bacterial, viral infection or treponema pallidum infection and so on.
- Requirement for urgent therapy due to tumor mass effects such as respiratory obstruction or blood vessel compression.
- Current or expected need for systemic corticosteroid therapy.
- Any organ failure.
- Patients with a second tumor requiring therapy or intervention.
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- Subjects considered unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation according to the investigator's judgement.
- Prior organ allograft.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Weidong D Han, M.D., +86-10-66937463, hanwdrsw69@yahoo.com
C
- Recruiting
Biotherapeutic Department of Chinese PLA General Hospital
Beijing
Weidong Han, M.D
About this study
Official title: An Open Label, Single Arm, Phase I/II in the Combination of Azacytidine, Bendamustine and Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's
This is an open label, single arm, phase I/II for patients with r/r Non-Hodgkin's Lymphoma
. The purpose is to evaluate the safety and efficacy of the combination with Azacytidine, Bendamustine and Piamprizumab
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Being tested
- Azacytidine, Bendamustine and Piamprizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacytidine, Bendamustine and PiamprizumabDrug
Azacytidine by means of subcutaneous injection, Bendamustine and Piamprizumab intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| combination of Azacytidine, Bendamustine and Piamprizumab | Experimental | combination of Azacytidine, Bendamustine and Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma, every 28 days Receives: Drug: Azacytidine, Bendamustine and Piamprizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
Measured: 6 month
Secondary outcomes (2)
Objective Response Rate
The ORR is defined as the proportion of patients with a best overall disease response, including complete response (CR) and partial response (PR).
Measured: 6 month
Complete Response Rate
CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start22 Apr 2021
- Primary completion23 Apr 2022 (estimated)
- Study completion23 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin Lymphoma,B CellStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897477
- Sponsor's protocol ID
- CHN-PLAGH-BT-066
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm, Phase I/II in the Combination of Azacytidine, Bendamustine and Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's
- ClinicalTrials.gov ID
- NCT04897477
- Acronym / sponsor ID
- CHN-PLAGH-BT-066
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 23 Apr 2022 (estimated)
- Study completion
- 23 Apr 2023 (estimated)
- First posted
- 21 May 2021 (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 an open label, single arm, phase I/II for patients with r/r Non-Hodgkin's Lymphoma
. The purpose is to evaluate the safety and efficacy of the combination with Azacytidine, Bendamustine and Piamprizumab
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combination of Azacytidine, Bendamustine and Piamprizumab | Experimental | Drug: Azacytidine, Bendamustine and Piamprizumabcombination of Azacytidine, Bendamustine and Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma, every 28 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 and ≤80 years
- Performance status (ECOG) between 0 and 3.
- Histologically confirmed B-cell non-Hodgkin lymphoma (NHL), including the following types defined by WHO 2016.
- Refractory disease or relapsed after treatment with ≥2 lines of chemotherapy and either having failed autologous HSCT or being ineligible for or not consenting to autologous HSCT; or not suitable for CAR T treatment or resistance, progression or relapse after CAR T treatment; or CAR T pre-culturing losers can also be enrolled.
- Adequate organ function.
Key exclusion criteria (9 listed)
- Pregnant or lactating women.
- Uncontrolled medical disorders, active bacterial, viral infection or treponema pallidum infection and so on.
- Requirement for urgent therapy due to tumor mass effects such as respiratory obstruction or blood vessel compression.
- Current or expected need for systemic corticosteroid therapy.
- Any organ failure.
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 |
|---|---|---|
| Azacytidine, Bendamustine and PiamprizumabAzacytidine by means of subcutaneous injection, Bendamustine and Piamprizumab intravenous infusion | Drug | combination of Azacytidine, Bendamustine and Piamprizumab |
Primary outcome
Safety: treatment-related adverse events (AEs)
Time frame: 6 month
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
2 secondary outcomes
Objective Response Rate
Time frame: 6 month
Complete Response Rate
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
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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.
2 sites 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 Azacytidine, Bendamustine and Piamprizumab in people with Non-hodgkin Lymphoma,B Cell, run by Chinese PLA General Hospital at 2 sites 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 10 inclusion and 9 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 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Weidong Han, M.D. (+861055499341, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: treatment-related adverse events (AEs) (time frame: 6 month). 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 21 May 2021.