Clinical trial · Interventional
Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients
An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma (FL).
NCT00494780CI-TRIAL-00015055MUNINcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)
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 |
|---|---|---|---|
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Ofatumumab | Drug | Ofatumumab | ALIAS |
| Prednisolone, Prednisone or equivalent | Drug | — | UNRESOLVED |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator 1
- description
- Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg
- interventionNames
- Drug: Ofatumumab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisolone, Prednisone or equivalent
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator 2
- description
- Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg
- interventionNames
- Drug: Ofatumumab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with Follicular Lymphoma (FL) * Confirmed diagnosis of Follicular lymphoma * 18 years or above * Verbal and written information about the study Exclusion Criteria: * No previous treatment for Follicular Lymphoma * Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma * Several diseases such as malignancies etc. * Screening laboratory values * Current participation in any other interventional clinical study * Breast feeding women or pregnant women * Women of childbearing potential not willing to use adequate contraception
References
Publications (1)
- BACKGROUNDCzuczman MS, Hess G, Gadeberg OV, Pedersen LM, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Strange C, Windfeld K, Viardot A; 409 Study Investigators. Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma. Br J Haematol. 2012 May;157(4):438-45. doi: 10.1111/j.1365-2141.2012.09086.x. Epub 2012 Mar 13. PMID 22409295