Clinical trial · Interventional
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-cell Lymphoma: NHL-13
- 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)
This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Follicular NHL Grade 3b | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Treatment
- interventionNames
- Drug: Rituximab
- type
- NO_INTERVENTION
- label
- B
- description
- Observation
Primary outcomes (1)
- measure
- event free survival
- timeFrame
- 4 years
Secondary outcomes (1)
- measure
- progression free survival, overall survival and safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 4 to 8 cycles R-CHOP/like, total of 8x Rituximab * CR, CRu * ECOG/ 0.1 or 2 * Known IPI at time of diagnosis * Age \> 18 years * Negative pregnancy test * Men must agree not to father a child during the therapy Exclusion Criteria: * Transformed lymphoma * Secondary malignancy * Evidence of CNS - involvement * Significant cardiac disease * Creatinine \> 2.0 mg/dl * HIV, Hepatitis positive
References
Publications (2)
- RESULTJaeger U, Trneny M, Melzer H, Praxmarer M, Nawarawong W, Ben Yehuda D, Goldstein D, Mihaljevic B, Ilhan O, Ballova V, Hedenus M, Hsiao LT, Au WY, Burgstaller S, Weidinger G, Keil F, Dittrich C, Skrabs C, Klingler A, Chott A, Fridrik MA, Greil R; AGMT-NHL13 Investigators. Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial. Haematologica. 2015 Jul;100(7):955-63. doi: 10.3324/haematol.2015.125344. Epub 2015 Apr 24. PMID 25911553
- RESULTJaeger U, Praxmarer M, Greil R; AGMT-NHL13 investigators. Response to comment by P. Vassilakopoulos and colleagues. Haematologica. 2015 Nov;100(11):e482. doi: 10.3324/haematol.2015.134288. No abstract available. PMID 26521299