Low-dose radiation therapy for recurrent advanced follicular lymphoma
A Prospective, Randomized, Open-label, Multi-center Study of Efficacy of Palliative Low-Dose Involved-Field Radiation Therapy for Recurrent Advanced Follicular Lymphoma: Wuhan University Cancer Center -NHL02 Trial
This study is testing if low-dose radiation therapy can help younger patients with recurrent advanced follicular lymphoma feel better and stay in remission longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Wuhan University Academic / other |
| Drugs / interventions | Rituximab, chemotherapy, Immunotherapy, radiation |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT02438501 on ClinicalTrials.gov |
What this trial studies
This trial investigates the efficacy of palliative low-dose involved-field radiation therapy (LD-IFRT) in patients under 65 years of age with recurrent advanced follicular lymphoma. The study aims to determine whether this treatment can achieve high response rates and durable remission in this patient population. Participants must have histologically confirmed follicular lymphoma Grade 1 or 2 and meet specific eligibility criteria, including adequate organ function and an ECOG performance status of 0 or 1. The trial will assess the impact of LD-IFRT on the natural history of the disease and overall patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are male and female patients aged 18 to 65 years with recurrent advanced follicular lymphoma Grade 1 or 2.
Not a fit: Patients who are pregnant, have uncontrolled metastases in the central nervous system, or have severe infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less aggressive yet effective option for managing recurrent advanced follicular lymphoma in younger patients.
How similar studies have performed: Previous studies have shown promising results with low-dose radiation therapy in similar patient populations, although some phase III trials have not demonstrated lasting response rates.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Both male and female aged range from 18 years to 65 years. * Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1. * All patients had histological confirmed follicular lymphoma Grade 1 or 2. * Recurrent patient with stage III and IV after initial management. * Had the indications for treatment provided by GELA. * Rituximab is too expensive to be managed for the patient. * Adequate organ function. * Negative pregnancy test. * Signed informed consent document on file. Exclusion Criteria: * Woman who were pregnant or lactating. * Had uncontrolled metastases in central nervous system. * With severe local infection or general infective disease. * Immunotherapy for the treatment of follicular lymphoma within 1 month prior to the start of this trial. * With other second primary malignancy except cutaneum carcinoma. * Being or planing to participate in other study. * Any patient who in the opinion of the investigator should not participate in the study. Withdrawal Criteria: * Patient are free to withdrawal completely from the study at any time upon request. * Patient in the study may be stopped with the patient agreement at any time at the discretion of investigator. * Continual consolidation chemotherapy after irradiation within the follow-up period. * In-field progression on irradiation ongoing. * Poor tolerability adverse events in the period of chemotherapy or irradiation after enrolled in the study.
Where this trial is running
Wuhan, Hubei
- DiDeng — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Di Deng, MD
- Email: dengdi69@163.com
- Phone: 0086-27-67813153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.