Trial Title:
Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT
NCT ID:
NCT02267915
Condition:
Mantle-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Rituximab
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
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
subcutaneous Rituximab
Description:
MabThera 1400 mg solution for subcutaneous injection
Arm group label:
subcutaneous rituximab
Other name:
MABTHERA
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
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)
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Gijon
Zip:
33394
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Alcorcon
Zip:
28922
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Barcelona
Zip:
08916
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Burgos
Zip:
09006
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Granada
Zip:
18014
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Madrid
Zip:
28031
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Santander
Zip:
39008
Country:
Spain
Facility:
Name:
Geltamo Investigational Site
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Start date:
March 2015
Completion date:
February 2020
Lead sponsor:
Agency:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Agency class:
Other
Source:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02267915
