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Phase II Randomized Study With R-DHAP +/- Bortezomib as Induction Therapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Patients Eligible to Transplantation. BR-DHAP Versus R-DHAP.

NCT01805557 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-06-08

No results posted yet for this study

Summary

The probability to achieve CR with R-chemotherapy in patients failing a rituximab containing first line regimen is quite low, in particular in cases with non GCB profile. The bioCORAL trial suggest that ABC subset have a dismal outcome whichever the induction treatment. Thus it can be argued the addition of new molecule to the RDHAP regimen could be of value. Bortezomib appears the best candidate in this setting as ABC subtypes constitutively express NFkb, which is the target of bortezomib itself. Data from the literature suggest an encouraging activity of R-chemo+ bortezomib in non GCB-derived DLBCL, although in small series. Thus, the addition of bortezomib is here justified by the need to circumvent constitutional resistance to chemotherapy. Published experience of the association between bortezomib and cytarabine are also encouraging with acceptable cumulative toxicity.

Conditions

  • Diffuse Large B-cell Lymphoma Refractory
  • Diffuse Large B-cell Lymphoma Recurrent

Interventions

DRUG

R-DHAP

* Rituximab 375 mg/sqm iv day 0 or 1 * Cisplatin 100 mg/sqm iv day 1 in 6-hours infusion * Cytarabine 2000 mg/sqm in 3-hours infusion iv day 2 and day 3 * Dexamethasone 40 mg day 1-4 * Pegfilgrastim 6 mg sc monodose 24 hours after the end of chemotherapy or G-CSF from day 5 till stem cell harvest during mobilization's course (II o III cycle R-DHAP) * Rituximab 375 mg/sqm iv 24 hours before apheresis as purging in vivo during second courses of therapy

DRUG

BR-DHAP

* Rituximab 375 mg/sqm iv day 0 or 1 * Bortezomib SC 1.5 mg/sqm day 1, day 4 * Cisplatin 100 mg/sqm iv day 1 in 6-hours infusion * Cytarabine 2000 mg/sqm in 3-hours infusion iv day 2 and day 3 * Dexamethasone 40 mg day 1-4 * Pegfilgrastim 6 mg sc monodose 24 hours after the end of chemotherapy or G-CSF from day 5 till stem cell harvest during mobilization's course (II o III cycle R-DHAP) * Rituximab 375 mg/sqm iv 24 hours before apheresis as purging in vivo during second courses of therapy Chemotherapy R-DHAP and BR-DHAP will be repeated every 28 days.

Sponsors & Collaborators

  • Janssen Pharmaceutica

    collaborator INDUSTRY

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

    collaborator OTHER

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Umberto Vitolo, MD · SC Ematologia 2-AO Città della Salute e della Sienza-Molinette

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
2013-02-04
Primary Completion
2019-03-12
Completion
2020-11-20

Countries

  • Italy

Study Locations

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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 NCT01805557 on ClinicalTrials.gov