Status:
UNKNOWN
Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT
Lead Sponsor:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Conditions:
Mantle-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02267915
Start Date
March 1 2015
End Date
February 1 2020
Last Update
January 27 2020
Active Locations (15)
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1
Geltamo Investigational Site
Santiago de Compostela, LA Coruña, Spain, 15706
2
Geltamo Investigational Site
Alcorcón, Madrid, Spain, 28922
3
Geltamo Investigational Site
Majadahonda, Madrid, Spain, 28222
4
Geltamo Investigational Site
Gijón, Principality of Asturias, Spain, 33394