Clinical trial · Interventional
HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab
A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy
NCT00394836CI-TRIAL-00013601completedPhase 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)
A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ofatumumab | Drug | Ofatumumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Number of Participants With Objective Response (OR)
- timeFrame
- Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)
- description
- OR was assessed by an Independent endpoints Review Committee (IRC) according to the standardized response criteria for Non-Hodgkin's lymphoma. Participants with Complete Response (CR; complete disappearance of all detectable disease), Complete Response unconfirmed (CRu; any residual lymph node/nodal mass \>1.5 centimeters \[cm\] in its longest transverse diameter that regressed \>75% compared to baseline), or Partial Response (PR; \>=50% decrease in the sum of the product of diameters of indicator lesions) were defined as responders for OR.
- measure
- Number of Participants Classified as Responders and Non-responders for Objective Response (OR)
- timeFrame
- 6-month period from the start of treatment. There was a median time of response at Month 5.5 (participants were followed for up to 24 months).
- description
- Based on OR over a 6-month period from start of treatment, participants were classified as responders/non-responders as follows: participants with CR, CRu, or PR were classified as responders, whereas participants with Stable Disease (SD; achieving less than PR but not consistent with PD), Progressive Disease (PD; 50% increase from nadir in the products of the greatest perpendicular diameters of any previously identified node or appearance of any new node \>1 cm), or Not Evaluable (NE) participants were classified as non-responders.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Patient with follicular lymphoma grade 1 - 2 * Refractory to rituximab given as monotherapy or in combination with any chemotherapy or to rituximab given as maintenance treatment following R-chemo, defined as: * failure to achieve at least PR to rituximab given as monotherapy or in combination with any chemotherapy; or, * disease progression while on rituximab (either given as monotherapy or in combination with any chemotherapy or during rituximab maintenance treatment following R-chemo); or, * disease progression in responders within 6 months of the last dose of rituximab (either given as monotherapy or in combination with any chemotherapy or after rituximab maintenance treatment schedule following R-chemo) * Tumor verified to be CD20+ positive from excisional lymph node biopsy * CT scan in screening phase (based on local evaluation) showing: * 2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or * 1 clearly demarcated lesion with a largest diameter ≥ 2,0 cm * ECOG Performance Status of 0, 1, or 2 * Age ≥ 18 years * Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out Exclusion Criteria * Previous autologous stem cell transplantation within 6 months * Previous allogeneic stem cell transplantation * More than 1 previous radio immunotherapy regimen * Received radio immunotherapy within 3 months * Received any Anti-cancer treatment within 4 weeks * Received monoclonal antibodies, other than rituximab within 3 months * Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab * Life expectancy less than 6 months
References
Publications (1)
- BACKGROUNDCzuczman MS, Fayad L, Delwail V, Cartron G, Jacobsen E, Kuliczkowski K, Link BK, Pinter-Brown L, Radford J, Hellmann A, Gallop-Evans E, DiRienzo CG, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Schultz M, Russell CA, Hagenbeek A; 405 Study Investigators. Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study. Blood. 2012 Apr 19;119(16):3698-704. doi: 10.1182/blood-2011-09-378323. Epub 2012 Mar 2. PMID 22389254