Indolent LymphomaPhase 2NCT05543070
Low-dose Radiotherapy in iNHL
A Phase 2 study testing Low-dose radiotherapy in people with Indolent Lymphoma and Low-dose Radiotherapy, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of low-dose radiotherapy (3 Gy*4f) in indolent lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Indolent Lymphoma, Low-dose Radiotherapy
- What is being tested?
- Low-dose radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Jan 2025
- Phase
- Phase 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
- Pathology proved iNHL
- ECOG PS ≤3
- Signed Informed consent
Who cannot join
- History of radiotherapy at the same site
- Primary malignant lymphoma of the gastrointestinal tract
- CTV (Clinical Target Volume)>500ml
- Others that researchers consider inappropriate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Shunan Qi, MD, +861087788995, medata@163.com
About this study
Official title: Low-dose Radiotherapy in Indolent Lymphoma：A Multi-center Phase II Study
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of low-dose radiotherapy (3 Gy*4f) in indolent lymphoma.
- Conditions
- Indolent Lymphoma, Low-dose Radiotherapy
- Being tested
- Low-dose radiotherapy
- Keywords
- indolent lymphoma, low-dose radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose radiotherapyRadiation
Electron Beam/3D-CRT/IMRT/VMAT
| Study group | Role | What they receive |
|---|---|---|
| Low-dose Radiotherapy | Experimental | Involved-site radiotherapy (3 Gy*4f) in one week Receives: Radiation: Low-dose radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical complete response after radiotherapy
complete resolution of disease in imaging or biopsy after low-dose radiotherapy
Measured: 6-month after radiotherapy
Secondary outcomes (6)
Overall response rate after radiotherapy
complete or partial resolution of disease in imaging or biopsy after low-dose radiotherapy
Measured: 6-month after radiotherapy
Progression-free survival rate at year 2 after enrollment, 2y-PFS
From enrollment to any disease progression or death
Measured: 2-year
Local control rate at year 2 after enrollment, 2y-LCR
From enrollment to any local disease progression or death
Measured: 2-year
Rate of acute toxicity (any and above grade 3)
toxicities according to CTCAE criteria
Measured: From enrollment to 3 months after treatment
Rate of late toxicity (any and above grade 3)
toxicities according to CTCAE criteria
Measured: After 3 months of enrollment
Quality of Life change, QoL
measurement basing on EORTC-QLQ-C30 tables
Measured: 1/3/6/12/24 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 May 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Indolent 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
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Province Cancer Hospital, Beijing Tongren Hospital, Fujian Medical University Union Hospital
- Responsible party
- Principal investigator, Shunan Qi, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543070
- Sponsor's protocol ID
- CLCG-iNHL-01
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Wang XY, Zhang XM, Wang L, Gao LR, Chen K, Feng XL, Rao W, Zheng R, Wu YP, Song YW, Fang H, Chen B, Jin J, Liu YP, Jing H, Tang Y, Zhang WW, Zhai YR, Lu NN, Li N, Xia CF, Wang SL, Liu X, Li YX, Qi SN. Low-dose moderate hypofractionated radiotherapy for indolent non-Hodgkin lymphoma: a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2025 Jun;12(6):e442-e450. doi: 10.1016/S2352-3026(25)00071-7. Epub 2025 May 2.
PubMed 40324445Gao LR, Wang X, Xia C, Song YW, Wang L, Li X, Yang Y, Cao JZ, Chen K, Zhong QZ, Gao Y, Zhou SY, Feng XL, Wang X, Li YX, Qi SN. Multicenter phase II study of moderate low-dose radiotherapy in indolent non-Hodgkin lymphoma: CLCG-iNHL-01 protocol. Future Oncol. 2024 Jan;20(2):71-81. doi: 10.2217/fon-2023-0761. Epub 2024 Jan 5.
PubMed 38179936
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Radiotherapy in Indolent Lymphoma：A Multi-center Phase II Study
- ClinicalTrials.gov ID
- NCT05543070
- Acronym / sponsor ID
- CLCG-iNHL-01
- Conditions
- Indolent Lymphoma, Low-dose Radiotherapy
- Keywords
- indolent lymphoma, low-dose radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Shanxi Province Cancer Hospital, Beijing Tongren Hospital, Fujian Medical University Union Hospital
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 16 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.
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of low-dose radiotherapy (3 Gy*4f) in indolent lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-dose Radiotherapy | Experimental | Radiation: Low-dose radiotherapyInvolved-site radiotherapy (3 Gy*4f) in one week |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pathology proved iNHL
- ECOG PS ≤3
- Signed Informed consent
Key exclusion criteria (4 listed)
- History of radiotherapy at the same site
- Primary malignant lymphoma of the gastrointestinal tract
- CTV (Clinical Target Volume)>500ml
- Others that researchers consider inappropriate
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 |
|---|---|---|
| Low-dose radiotherapyElectron Beam/3D-CRT/IMRT/VMAT | Radiation | Low-dose Radiotherapy |
Primary outcome
Rate of clinical complete response after radiotherapy
Time frame: 6-month after radiotherapy
complete resolution of disease in imaging or biopsy after low-dose radiotherapy
6 secondary outcomes
Overall response rate after radiotherapy
Time frame: 6-month after radiotherapy
Progression-free survival rate at year 2 after enrollment, 2y-PFS
Time frame: 2-year
Local control rate at year 2 after enrollment, 2y-LCR
Time frame: 2-year
Rate of acute toxicity (any and above grade 3)
Time frame: From enrollment to 3 months after treatment
Rate of late toxicity (any and above grade 3)
Time frame: After 3 months of enrollment
Quality of Life change, QoL
Time frame: 1/3/6/12/24 months after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Derived from this study: PubMed 40324445Wang XY, Zhang XM, Wang L, Gao LR, Chen K, Feng XL, Rao W, Zheng R, Wu YP, Song YW, Fang H, Chen B, Jin J, Liu YP, Jing H, Tang Y, Zhang WW, Zhai YR, Lu NN, Li N, Xia CF, Wang SL, Liu X, Li YX, Qi SN. Low-dose moderate hypofractionated radiotherapy for indolent non-Hodgkin lymphoma: a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2025 Jun;12(6):e442-e450. doi: 10.1016/S2352-3026(25)00071-7. Epub 2025 May 2.
- Derived from this study: PubMed 38179936Gao LR, Wang X, Xia C, Song YW, Wang L, Li X, Yang Y, Cao JZ, Chen K, Zhong QZ, Gao Y, Zhou SY, Feng XL, Wang X, Li YX, Qi SN. Multicenter phase II study of moderate low-dose radiotherapy in indolent non-Hodgkin lymphoma: CLCG-iNHL-01 protocol. Future Oncol. 2024 Jan;20(2):71-81. doi: 10.2217/fon-2023-0761. Epub 2024 Jan 5.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
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Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma
Active, not recruitingPhase 1/2
Selinexor Plus Combination Chemotherapy in Treating Patients With Advanced B Cell Non-Hodgkin Lymphoma
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Not yet recruitingPhase 1
Axatilimab + CAR-T for High-Risk Lymphoma
Diffuse Large B Cell Lymphoma (DLBCL), Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
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.
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
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 Low-dose radiotherapy in people with Indolent Lymphoma and Low-dose Radiotherapy, run by Chinese Academy of Medical Sciences 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 3 inclusion and 4 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 16 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinical complete response after radiotherapy (time frame: 6-month after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05543070, which also lists 2 linked publications.
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 16 Sep 2022; AzTrials last refreshed its copy on 2 Nov 2026.