Relapsed Classic Hodgkin LymphomaPhase 2NCT06190067
Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma
A Phase 2 study testing Azacitidine Plus PD-1 therapy in people with Relapsed Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, run by Navy General Hospital, Beijing at 1 site in China.
Trial summary
The goal of this phase 2 trial is to test the safety and efficacy of azacitidine when given together with PD-1 therapy in treating patients with relapsed/refractory classic Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma
- What is being tested?
- Azacitidine Plus PD-1 therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2023to Dec 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed Hodgkin Lymphoma according World Health Organization (WHO) classification.
- Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.
- Patient is willing and able to adhere to the study visit schedule and other protocol requirements.
- Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below).
- Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10^9/L (≥ 1 x 10^9/L if bone marrow (BM) involvement by lymphoma); Platelet ≥ 75 x 10^9/L (≥ 50 x 10^9/L if BM involvement by lymphoma); Hemoglobin ≥ 8 g/dL.
- Anticipated life expectancy at least 3 months.
Who cannot join
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
- Pregnant or lactating women.
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, 1 recruiting
- Recruiting
Navy General Hospital
Beijing, Beijing Municipality, 100048
Liren Qian, M.D., +861066957676, qlr2007@126.com
About this study
Official title: Azacitidine Plus PD-1 Therapy for Relapsed/Refractory Hodgkin Lymphoma
The goal of this phase 2 trial is to test the safety and efficacy of azacitidine when given together with PD-1 therapy in treating patients with relapsed/refractory classic Hodgkin lymphoma.
Read the detailed description
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with PD-1 therapy in classic relapsed/refractory Hodgkin lymphoma.
- Being tested
- Azacitidine Plus PD-1 therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine Plus PD-1 therapyDrug
Also called Azacitidine Plus PD-1 antibody
Patients were treated by Azacytidine(75 mg/m2 subcutaneous injection qd on days 1-7) plus PD-1 therapy(200mg iv qd d8)
| Study group | Role | What they receive |
|---|---|---|
| Azacitidine Plus PD-1 therapy | Experimental | Patients were treated by Azacitidine plus PD-1 therapy Receives: Drug: Azacitidine Plus PD-1 therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR was defined as the proportion of patients who achieved CR or PR as their best response
Measured: 1 year
Secondary outcomes (2)
Overall Survival (OS)
OS was defined as time from diagnosis to death from any cause or the last follow-up
Measured: through study completion, an average of 2 year
Progression Free Survival (PFS)
PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start30 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Classic Hodgkin LymphomaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liren Qian, Navy General Hospital, Beijing
- Investigators
- Liren Qian, PhD, Principal investigator, Navy General Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190067
- Sponsor's protocol ID
- PA2023
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 30 Jan 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azacitidine Plus PD-1 Therapy for Relapsed/Refractory Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06190067
- Acronym / sponsor ID
- PA2023
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Jan 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.
The goal of this phase 2 trial is to test the safety and efficacy of azacitidine when given together with PD-1 therapy in treating patients with relapsed/refractory classic Hodgkin lymphoma.
Detailed description
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with PD-1 therapy in classic relapsed/refractory Hodgkin lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azacitidine Plus PD-1 therapy | Experimental | Drug: Azacitidine Plus PD-1 therapyPatients were treated by Azacitidine plus PD-1 therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed Hodgkin Lymphoma according World Health Organization (WHO) classification.
- Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.
- Patient is willing and able to adhere to the study visit schedule and other protocol requirements.
- Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below).
Key exclusion criteria (3 listed)
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
- Pregnant or lactating women.
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 Plus PD-1 therapyAlso: Azacitidine Plus PD-1 antibodyPatients were treated by Azacytidine(75 mg/m2 subcutaneous injection qd on days 1-7) plus PD-1 therapy(200mg iv qd d8) | Drug | Azacitidine Plus PD-1 therapy |
Primary outcome
Overall Response Rate (ORR)
Time frame: 1 year
ORR was defined as the proportion of patients who achieved CR or PR as their best response
2 secondary outcomes
Overall Survival (OS)
Time frame: through study completion, an average of 2 year
Progression Free Survival (PFS)
Time frame: 18 months
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 30 Jan 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.
Liren Qian, PhD principal investigator
Navy General Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine Plus PD-1 therapy in people with Relapsed Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, run by Navy General Hospital, Beijing 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 3 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: looking for participants now, as of the sponsor's last update on 30 Jan 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.
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?
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 Liren Qian, PhD (+861066947192, qlr2007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: 1 year). 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 30 Jan 2024.