NCT02267915

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_2

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 27, 2020

Status Verified

May 1, 2019

Enrollment Period

4.8 years

First QC Date

October 3, 2014

Last Update Submit

January 24, 2020

Conditions

Mantle-cell Lymphoma

Keywords

Relapsed or refractory patients with mantle-cell lymphomaProgression after high-dose chemotherapy and autologous HPT

Outcome Measures

Primary Outcomes (1)

  • Time to progression, (Measured from achievement of response -partial or complete- to to disease progression)

    2 years after last patient randomized in maintenance

    2 YEARS

Study Arms (1)

subcutaneous rituximab

EXPERIMENTAL

MabThera 1400 mg solution for subcutaneous injection

Drug: subcutaneous Rituximab

Interventions

subcutaneous RituximabDRUG

MabThera 1400 mg solution for subcutaneous injection

Also known as: MABTHERA
subcutaneous rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Geltamo Investigational Site

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Geltamo Investigational Site

Alcorcón, Madrid, 28922, Spain

Location

Geltamo Investigational Site

Majadahonda, Madrid, 28222, Spain

Location

Geltamo Investigational Site

Gijón, Principality of Asturias, 33394, Spain

Location

Geltamo Investigational Site

Barcelona, 08003, Spain

Location

Geltamo Investigational Site

Barcelona, 08035, Spain

Location

Geltamo Investigational Site

Barcelona, 08036, Spain

Location

Geltamo Investigational Site

Barcelona, 08041, Spain

Location

Geltamo Investigational Site

Barcelona, 08916, Spain

Location

Geltamo Investigational Site

Burgos, 09006, Spain

Location

Geltamo Investigational Site

Granada, 18014, Spain

Location

Geltamo Investigational Site

Madrid, 28031, Spain

Location

Geltamo Investigational Site

Salamanca, 37007, Spain

Location

Geltamo Investigational Site

Santander, 39008, Spain

Location

Geltamo Investigational Site

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Lymphoma, Mantle-CellRecurrence

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Andres Lopez, DOCTOR

    Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 20, 2014

Study Start

March 1, 2015

Primary Completion

December 1, 2019

Study Completion

February 1, 2020

Last Updated

January 27, 2020

Record last verified: 2019-05

Locations

ES(15)