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

Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Study ID
NCT02267915
Phase
PHASE2
Status
Unknown

Conditions

  • Mantle-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Mar 31, 2015
Status verified
May 2019
Primary completion
Dec 31, 2019
Completion
Feb 29, 2020

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: subcutaneous rituximab
    MabThera 1400 mg solution for subcutaneous injection

Primary Outcome Measure

Time to progression, (Measured from achievement of response -partial or complete- to to disease progression) [ Time Frame: 2 YEARS ]

Related Studies