search
Back to results

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

Primary Purpose

Mantle-cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
subcutaneous Rituximab
Sponsored by
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle-cell Lymphoma focused on measuring Relapsed or refractory patients with mantle-cell lymphoma, Progression after high-dose chemotherapy and autologous HPT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site
  • Geltamo Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

subcutaneous rituximab

Arm Description

MabThera 1400 mg solution for subcutaneous injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 3, 2014
Last Updated
January 24, 2020
Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
search

1. Study Identification

Unique Protocol Identification Number
NCT02267915
Brief Title
Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT
Acronym
MAN2
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy Secondary endpoints: Quality of response obtained after subcutaneous Rituximab maintenance. Progression-Free Survival (PFS) Overall Survival (OS) Time to Next Therapy (TTNT) Value of MRD in the disease outcome 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle-cell Lymphoma
Keywords
Relapsed or refractory patients with mantle-cell lymphoma, Progression after high-dose chemotherapy and autologous HPT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subcutaneous rituximab
Arm Type
Experimental
Arm Description
MabThera 1400 mg solution for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
subcutaneous Rituximab
Other Intervention Name(s)
MABTHERA
Intervention Description
MabThera 1400 mg solution for subcutaneous injection
Primary Outcome Measure Information:
Title
Time to progression, (Measured from achievement of response -partial or complete- to to disease progression)
Description
2 years after last patient randomized in maintenance
Time Frame
2 YEARS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Lopez, DOCTOR
Organizational Affiliation
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Official's Role
Study Director
Facility Information:
Facility Name
Geltamo Investigational Site
City
Gijon
State/Province
Asturias
ZIP/Postal Code
33394
Country
Spain
Facility Name
Geltamo Investigational Site
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Geltamo Investigational Site
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Geltamo Investigational Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Geltamo Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Geltamo Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Geltamo Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Geltamo Investigational Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Geltamo Investigational Site
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Geltamo Investigational Site
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Geltamo Investigational Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Geltamo Investigational Site
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Geltamo Investigational Site
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Geltamo Investigational Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Geltamo Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs