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Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT
Conditions
Mantle-cell Lymphoma
Conditions: official terms
Lymphoma, Mantle-Cell
Conditions: Keywords
Relapsed or refractory patients with mantle-cell lymphoma, Progression after high-dose chemotherapy and autologous HPT
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: subcutaneous Rituximab
Type: Drug
Overall Status
Not yet recruiting
Summary
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
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
Detailed Description
This is a phase II trial evaluating the role of maintenance with subcutaneous Rituximab in patients with stage II-IV relapsed or refractory mantle-cell lymphoma with complete or partial response after the administration of a salvage regimen with R-GemOx-D.
Before the study start and in order to standardize the results, the same R-GemOx-D salvage regimen will be used: Rituximab: 375 mg/m2 on day 1, Gemcitabine: 1000 mg/m2 on day 2 (over 30 minutes) and Oxaliplatin: 100 mg/m2 on day 2 (over 3 hours), Dexamethasone 20 mg on day 1-3. Cycles should be repeated every 14 days, up to 8 cycles.
Patients who present a complete or partial response, after the salvage therapy, will start the study receiving subcutaneous Rituximab maintenance at dose of: 1400 mg every 2 months for 2 years; the study treatment will start 6-8 weeks after finishing the salvage therapy.
Patients will be evaluated every 2 months during treatment study phase and every 4 months in the follow up phase. More details in Appendix 1 (Schedule of Assessments)
Before the study start and in order to standardize the results, the same R-GemOx-D salvage regimen will be used: Rituximab: 375 mg/m2 on day 1, Gemcitabine: 1000 mg/m2 on day 2 (over 30 minutes) and Oxaliplatin: 100 mg/m2 on day 2 (over 3 hours), Dexamethasone 20 mg on day 1-3. Cycles should be repeated every 14 days, up to 8 cycles.
Patients who present a complete or partial response, after the salvage therapy, will start the study receiving subcutaneous Rituximab maintenance at dose of: 1400 mg every 2 months for 2 years; the study treatment will start 6-8 weeks after finishing the salvage therapy.
Patients will be evaluated every 2 months during treatment study phase and every 4 months in the follow up phase. More details in Appendix 1 (Schedule of Assessments)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
- 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.
Location
Start Date
September 2015
Completion Date
November 2017
Sponsors
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Source
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page