Clinical trial · Interventional
A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas
An Open-label Study of Fludarabine and Cyclophosphamide Plus MabThera Followed by Maintenance With MabThera on Failure-free Survival in Treatment-naïve Patients With Advanced Indolent B-cell Nonfollicular Lymphoma
NCT01153971CI-TRIAL-00028895completedPhase 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)
This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.
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 |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: rituximab
Primary outcomes (1)
- measure
- Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date
- timeFrame
- Month 28
- description
- Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures.
Secondary outcomes (17)
- measure
- Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase
- timeFrame
- Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients 18-65 years of age; * previously untreated indolent nonfollicular non-Hodgkin's lymphoma; * active disease; * \>=3 involved sites. Exclusion Criteria: * typical chronic lymphocytic leukemia; * other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix; * systemic corticosteroid use for \>1 month; * significant cardiovascular disease; * central nervous system involvement; * hepatitis B or C virus infection, or HIV infection.
References
Publications (0)
Data not yet available
No reference posted for this study.