Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT (MAN2)

January 24, 2020 updated by: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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

  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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Geltamo Investigational Site
      • Barcelona, Spain, 08035
        • Geltamo Investigational Site
      • Barcelona, Spain, 08036
        • Geltamo Investigational Site
      • Barcelona, Spain, 08041
        • Geltamo Investigational Site
      • Barcelona, Spain, 08916
        • Geltamo Investigational Site
      • Burgos, Spain, 09006
        • Geltamo Investigational Site
      • Granada, Spain, 18014
        • Geltamo Investigational Site
      • Madrid, Spain, 28031
        • Geltamo Investigational Site
      • Salamanca, Spain, 37007
        • Geltamo Investigational Site
      • Santander, Spain, 39008
        • Geltamo Investigational Site
      • Sevilla, Spain, 41013
        • Geltamo Investigational Site
    • Asturias
      • Gijon, Asturias, Spain, 33394
        • Geltamo Investigational Site
    • LA Coruña
      • Santiago de Compostela, LA Coruña, Spain, 15706
        • Geltamo Investigational Site
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Geltamo Investigational Site
      • Majadahonda, Madrid, Spain, 28222
        • Geltamo Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: subcutaneous rituximab
MabThera 1400 mg solution for subcutaneous injection
Drug: subcutaneous Rituximab
MabThera 1400 mg solution for subcutaneous injection
Other Names:
  • MABTHERA

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Investigators

  • Study Director: Andres Lopez, DOCTOR, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2015

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ANTICIPATED)

February 1, 2020

Study Registration Dates

First Submitted

October 3, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (ESTIMATE)

October 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GELTAMO-MAN2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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