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Trial record 4 of 8 for:    Andres Lopez

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02267915
Recruitment Status : Unknown
Verified May 2019 by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea.
Recruitment status was:  Active, not recruiting
First Posted : October 20, 2014
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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

Condition or disease Intervention/treatment Phase
Mantle-cell Lymphoma Drug: subcutaneous Rituximab Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 2015
Actual Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: subcutaneous rituximab
MabThera 1400 mg solution for subcutaneous injection
Drug: subcutaneous Rituximab
MabThera 1400 mg solution for subcutaneous injection
Other Name: MABTHERA




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267915


Locations
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Spain
Geltamo Investigational Site
Gijon, Asturias, Spain, 33394
Geltamo Investigational Site
Santiago de Compostela, LA Coruña, Spain, 15706
Geltamo Investigational Site
Alcorcon, Madrid, Spain, 28922
Geltamo Investigational Site
Majadahonda, Madrid, Spain, 28222
Geltamo Investigational Site
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
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Investigators
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Study Director: Andres Lopez, DOCTOR Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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Responsible Party: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier: NCT02267915    
Other Study ID Numbers: GELTAMO-MAN2
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: May 2019
Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
Relapsed or refractory patients with mantle-cell lymphoma
Progression after high-dose chemotherapy and autologous HPT
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents