Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT

• Status: Unknown status
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Treatments: Rituximab

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.