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

NCT02267915 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-01-27

No results posted yet for this study

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

Conditions

  • Mantle-cell Lymphoma

Interventions

DRUG

subcutaneous Rituximab

MabThera 1400 mg solution for subcutaneous injection

Sponsors & Collaborators

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

    lead OTHER

Principal Investigators

  • Andres Lopez, DOCTOR · Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-12-31
Completion
2020-02-29

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02267915 on ClinicalTrials.gov