Clinical trial · Interventional
Adjustment of Chemotherapy Duration in Follicular Lymphoma According to Minimal Residual Disease Status
Adjustment of Chemotherapy Duration in Follicular Lymphoma Patients According to Peripheral Blood or Bone Marrow Minimal Residual Disease Status
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Follicular lymphoma (FL) is a chronic indolent malignancy, where treatment with 6 cycles of bendamustine obinutuzumab (BO) is highly effective but at a cost of increased adverse events. Tumor specific DNA can be traced in blood and bone marrow of follicular lymphoma patients even after therapy, and when detected after lymphoma treatment it is referred to as minimal residual disease (MRD). MRD elimination after effective lymphoma treatment is a marker for deep response and correlates with prolonged remission. In this study we aim to omit chemotherapy after 4 cycles of treatment in patients achieving MRD elimination after 3 months of therapy, as well as complete metabolic response on positron emission computed tomography (PET-CT), hoping to preserve treatment effectiveness while reducing adverse events.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustin | Drug | — | UNRESOLVED |
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Reduced number of bendamustine cycles in patients with mid-induction MRD negativity
- description
- Patients with follicular lymphoma treated with obinutuzumab bendamustine \& achieving MRD negativity as well as complete metabolic response on PET-CT at mid-induction would continue obinutuzumab treatment while omitting bendamustin after 4 cycles.
- interventionNames
- Drug: Bendamustin
- Drug: Obinutuzumab
Primary outcomes (1)
- measure
- Progression free survival among patients treated with 4 cycles of BO & 2 additional cycles of obinutuzumab.
- timeFrame
- Progression free survival will be assessed 24 months after the end of induction.
- description
- Progression-free survival is defined as the time from randomization to the earliest event of progression, relapse, or death from any cause. progression-free survival, is assessed by the investigator.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available