Relapsed Peripheral T-Cell LymphomasPhase 1/2NCT06176027
Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Peripheral T-Cell Lymphomas
A Phase 1/2 study testing Azacytidine plus CAOLD regimen in people with Relapsed Peripheral T-Cell Lymphomas and Refractory Peripheral T-Cell Lymphomas, run by Navy General Hospital, Beijing at 1 site in China.
Trial summary
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with CAOLD Regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Peripheral T-Cell Lymphomas, Refractory Peripheral T-Cell Lymphomas
- What is being tested?
- Azacytidine plus CAOLD regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Sep 2030
- Phase
- Phase 1/2
- 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
- Patients must satisfy all following criteria to be enrolled in the study:
- Pathologically confirmed angioimmunoblastic T-cell 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.)
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- 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: Therapeutic Effect of Chemotherapy Azacytidine Plus CAOLD Regimen on Patients With Relapsed/Refractory Peripheral T-Cell Lymphomas
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with CAOLD Regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas.
Read the detailed description
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with CAOLD Regimen in relapsed/refractory peripheral t-cell lymphomas.
- Being tested
- Azacytidine plus CAOLD regimen
- 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.
Azacytidine plus CAOLD regimenDrug
Patients were treated by Azacytidine(75 mg/m2 on days 1-7) plus CAOLD regimen (cyclophosphamide 400mg/m2 qd d1; cytarabine 30mg/m2 qd d1-d4; vindesine 2mg/m2 qd d1; pegaspargase 2500iu/m2 qd d2; dexamethasone 7.5mg/m2 qd d1-d5)
| Study group | Role | What they receive |
|---|---|---|
| Azacytidine plus CAOLD regimen | Experimental | Patients were treated by Azacytidine plus CAOLD regimen Receives: Drug: Azacytidine plus CAOLD regimen |
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 posted19 Dec 2023
- Study start1 Oct 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2030 (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 LymphomasStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Principal investigator, Liren Qian, Navy General Hospital, Beijing
- Investigators
- Liren Qian, PhD, Study chair, Navy General Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176027
- Sponsor's protocol ID
- NavyGHB-008
- Status last verified
- Oct 2024
- First submitted
- 5 Aug 2023
- Last updated
- 29 Oct 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 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Chemotherapy Azacytidine Plus CAOLD Regimen on Patients With Relapsed/Refractory Peripheral T-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT06176027
- Acronym / sponsor ID
- NavyGHB-008
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 19 Dec 2023 (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 single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with CAOLD Regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas.
Detailed description
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with CAOLD Regimen in relapsed/refractory peripheral t-cell lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azacytidine plus CAOLD regimen | Experimental | Drug: Azacytidine plus CAOLD regimenPatients were treated by Azacytidine plus CAOLD regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically confirmed angioimmunoblastic T-cell 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 |
|---|---|---|
| Azacytidine plus CAOLD regimenPatients were treated by Azacytidine(75 mg/m2 on days 1-7) plus CAOLD regimen (cyclophosphamide 400mg/m2 qd d1; cytarabine 30mg/m2 qd d1-d4; vindesine 2mg/m2 qd d1; pegaspargase 2500iu/m2 qd d2; dexamethasone 7.5mg/m2 qd d1-d5) | Drug | Azacytidine plus CAOLD regimen |
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 29 Oct 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 study chair
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 1/2 study testing Azacytidine plus CAOLD regimen in people with Relapsed Peripheral T-Cell Lymphomas and Refractory Peripheral T-Cell Lymphomas, 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 11 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 29 Oct 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 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?
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 (+861066957676, 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 29 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.