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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02267915

Acronym

MAN2

Enrollment

Registered

2014-10-20

Start date

2015-03-31

Completion date

2020-02-29

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle-cell Lymphoma

Keywords

Relapsed or refractory patients with mantle-cell lymphoma, Progression after high-dose chemotherapy and autologous HPT

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 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)

Interventions

DRUGsubcutaneous Rituximab

MabThera 1400 mg solution for subcutaneous injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to progression, (Measured from achievement of response -partial or complete- to to disease progression)	2 YEARS	2 years after last patient randomized in maintenance

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026