Adjusting chemotherapy duration for follicular lymphoma based on minimal residual disease status
Adjustment of Chemotherapy Duration in Follicular Lymphoma Patients According to Peripheral Blood or Bone Marrow Minimal Residual Disease Status
This study tests if shortening chemotherapy for people with follicular lymphoma who show no signs of cancer after three months can still be effective while reducing side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Meir Medical Center Academic / other |
| Drugs / interventions | chemotherapy, obinutuzumab, rituximab, immunotherapy, cyclophosphamide, doxorubicin, prednisone |
| Locations | 1 site (Kfar Saba) |
| Trial ID | NCT04934930 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the possibility of reducing chemotherapy duration in patients with follicular lymphoma who achieve minimal residual disease (MRD) elimination after three months of treatment. Patients will receive four cycles of bendamustine and obinutuzumab, and if they show a complete metabolic response on PET-CT, they will not receive the standard six cycles of chemotherapy. The goal is to maintain treatment effectiveness while minimizing adverse events associated with prolonged chemotherapy. This approach is based on the correlation between MRD elimination and prolonged remission in follicular lymphoma patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and above with untreated follicular lymphoma grade I-IIIa and high tumor bulk.
Not a fit: Patients with follicular lymphoma grade IIIb, those with HIV, active malignancies other than FL, or who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer treatment regimen for follicular lymphoma patients, reducing the risk of adverse events while maintaining effective disease control.
How similar studies have performed: Previous studies have shown promising results with similar approaches in managing follicular lymphoma, particularly regarding the correlation between MRD status and treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 and above. 2. FL grade I-IIIa, according to world health organization (WHO) classification, in patients who were not previously treated with chemotherapy, have a high tumor bulk \& an indication for treatment, as defined by the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria. 3. Eastern Cooperative Oncology Group (ECOG) performance status grade 0-2. 4. The presence of a molecular marker in bone marrow or peripheral blood for MRD assessment. Exclusion Criteria: 1. FL grade IIIb. 2. HIV infection. 3. HBsAg positivity. 4. Active malignancy other than FL 5. Pregnancy or lactation.
Where this trial is running
Kfar Saba
- Meir medical center — Kfar Saba, Israel (Recruiting)
Study contacts
- Principal investigator: Uri Abadi, MD — Meir Medical Center
- Study coordinator: Uri Abadi, MD
- Email: uri.abadi@clalit.org.il
- Phone: 972-9-7472786
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.