Intensive induction treatment with antibody therapy (Rituximab), chemotherapy (Ara-C) and steroids (dexamethasone) and bone marrow transplant in aggressive mantle cell lymphoma patients younger that 66 years.

Rituximab, High Dose Ara-C and Dexamethasone Followed by BEAM in Mantle Cell Lymphoma Patients <66 Years - MCL5 MARiT Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004039-30-GB

Enrollment

Registered

2012-02-23

Start date

2012-04-03

Completion date

Unknown

Last updated

2012-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle Cell Lymphoma MedDRA version: 14.1 Level: LLT Classification code 10026799 Term: Mantle cell lymphoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Mabthera Product Name: Mabthera Pharmaceutical Form: Solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1.Severe cardiac disease: NYHA grade 3-4. 2.Impaired liver, renal (GFR<50ml/min) or other organ function not caused by lymphoma, which will interfere with the treatment. 3.Pregnancy/lactation 4.Men or women of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment. 5.Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma. 6.Known seropositivity for HIV, HCV, HBsAg or other active infection uncontrolled by treatment. 7.Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To increase the complete response rate pre-transplant in aggressive mantle cell lymphoma by intensified immunochemotherapy with rituximab, high dose Ara-C and dexamethasone. In the NORDIC area only high risk patients (MIPI-B) are included, while in the UK all patients in need of treatment are included. The result in all patients will be compared to a historic control of corresponding patients in the NORDIC MCL2 trial.;Secondary Objective: To improve the following: Time to treatment failure Progression free survival rate Overall survival Toxicity The evaluation of response with FDG-PET The evaluation of response with MRD The stem cell harvest yield The evaluation of biomarkers for biology and prediction of response To establish a bio bank ;Primary end point(s): Complete remission pre-transplant;Timepoint(s) of evaluation of this end point: Week 15	—

Measure

Time frame

Main Objective: To increase the complete response rate pre-transplant in aggressive mantle cell lymphoma by intensified immunochemotherapy with rituximab, high dose Ara-C and dexamethasone. In the NORDIC area only high risk patients (MIPI-B) are included, while in the UK all patients in need of treatment are included. The result in all patients will be compared to a historic control of corresponding patients in the NORDIC MCL2 trial.;Secondary Objective: To improve the following: Time to treatment failure Progression free survival rate Overall survival Toxicity The evaluation of response with FDG-PET The evaluation of response with MRD The stem cell harvest yield The evaluation of biomarkers for biology and prediction of response To establish a bio bank ;Primary end point(s): Complete remission pre-transplant;Timepoint(s) of evaluation of this end point: Week 15

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Secondary

Measure	Time frame
Secondary end point(s): Over all survival Time to treatment failure Time to progression Evaluation of response with FDG-PET and MRD Stem cell harvest yield Evaluation of biomarkers for biology and prediction of response and response duration;Timepoint(s) of evaluation of this end point: Every 3 months for 2 years, then every 6 months for 5 years. FDG-PET evaluation week 15 and 3 months post transplant MRD evaluation weeks 9 and 15 and then 3 months post transplant MRD evaluation weeks 9 and 15, then 3 and 6 months post-transplant, then every 6 months for 5 years.	—

Measure

Time frame

Secondary end point(s): Over all survival Time to treatment failure Time to progression Evaluation of response with FDG-PET and MRD Stem cell harvest yield Evaluation of biomarkers for biology and prediction of response and response duration;Timepoint(s) of evaluation of this end point: Every 3 months for 2 years, then every 6 months for 5 years. FDG-PET evaluation week 15 and 3 months post transplant MRD evaluation weeks 9 and 15 and then 3 months post transplant MRD evaluation weeks 9 and 15, then 3 and 6 months post-transplant, then every 6 months for 5 years.

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Countries

United Kingdom

Contacts

Public ContactRule

Plymouth Hospitals NHS Trust

simon.rule@phnt.swest.nhs.uk01752 517504

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026