Clinical trial · Interventional
Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT
An Open Multicenter Phase II Study of Efficacy and Toxicity of Maintenance Subcut. Rituximab After Induction With Rituximab in Patients With Relapsed or Refractory Mantle-cell Lymphoma Non-eligible for HSCT
- 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)
1. Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy 2. Secondary endpoints: 1. Quality of response obtained after subcutaneous Rituximab maintenance. 2. Progression-Free Survival (PFS) 3. Overall Survival (OS) 4. Time to Next Therapy (TTNT) 5. Value of MRD in the disease outcome 6. Toxicity
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 |
|---|---|---|---|
| Mantle-cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| subcutaneous Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- subcutaneous rituximab
- description
- MabThera 1400 mg solution for subcutaneous injection
- interventionNames
- Drug: subcutaneous Rituximab
Primary outcomes (1)
- measure
- Time to progression, (Measured from achievement of response -partial or complete- to to disease progression)
- timeFrame
- 2 YEARS
- description
- 2 years after last patient randomized in maintenance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Basal diagnosis of mantle-cell lymphoma in relapse or refractory. * Achievement of a CR or PR after salvage therapy with R-GemOxD (6 to 8 cycles) as previously described4-5. * Age \> 18 years. * One or maximum two prior chemotherapy or immunochemotherapy lines. * Patients should not be considered candidates for high-dose chemotherapy and autologous stem-cell transplantation. * No clinical evidence of CNS involvement * Signed informed consent * Serum creatinine less than 2 and/or bilirrubin less than 2.5 UNL. * Pregnant or lactating woman. FCBP must agree to ongoing pregnancy testing during the course or study and commit to use effective contraception during the study Exclusion Criteria: * Prior organ transplantation. * HIV positive. * HBV related disease * Any serious active disease or co-morbid medical condition (according to the investigator's decision) * Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 cervix carcinoma. * Less than 50% of tumor response. * Platelet counts less than 50 x 109/L. * Neutrophil counts less than 1.0 x 109/L.
References
Publications (0)
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