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ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma

NCT02858258 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 870

Last updated 2017-12-19

No results posted yet for this study

Summary

The primary objective of the the trial is to establish one of three study arms, as future standard based on the comparison of the investigator-assessed failure-free survival.

Conditions

Interventions

DRUG

R-CHOP/R-DHAP

Drug: R-CHOP/DHAP Alternating 3x R-CHOP (Rituximab , Cyclophosphamide ,Doxorubicine ,Vincristine , Prednisone) / 3x R-DHAP (Rituximab , Dexamethasone, Ara-C, Cisplatine, G-CSF)

DRUG

Ibrutinib (Induction)

Ibrutinib: only in cycle 1,3,5 on Day 1-19

DRUG

ASCT conditioning

ASCT conditioning THAM or BEAM, stratified per site before trial activation at site THAM (TBI (total body irradiation), Ara-C, Melphalan) or BEAM (BCNU, Etoposide, Cytarabine, Melphalan)

DRUG

Ibrutinib (Maintenance)

Ibrutinib (Maintenance), daily 560 mg for 2 years;

Sponsors & Collaborators

  • LMU Klinikum

    collaborator OTHER

  • Prof. Dr. M. Dreyling (co-chairman)

    lead OTHER

Principal Investigators

  • Martin Dreyling, Prof. · Klinikum der Universität München

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2021-05-31
Completion
2026-05-31

Countries

  • Denmark
  • Germany
  • Italy
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02858258 on ClinicalTrials.gov