MedTrace Logo

Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients

NCT02374424 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2022-06-06

No results posted yet for this study

Summary

Aim of this trial is to assess the efficacy of new anti-CD20 antibody (GA101) in association with DHAP as induction therapy before high dose chemotherapy BEAM with ASCT in patients with relapsed/refractory DLBCL.

Conditions

  • Diffuse, Large B-Cell, Lymphoma

Interventions

DRUG

GA101_DHAP

Aim of the study is to assess whether the addition of GA101 to DHAP is more promising than standard R-DHAP, as induction therapy before high dose chemotherapy BEAM with ASCT with respect to response. Scheme of treatment: * GA101 1000 mg iv day 1, 8, 15 on first cycle (starting from cycle 2, GA101 1000 mg day 1) * Cisplatin 100 mg/sqm iv day 1 of every cycles in 24-hours infusion * Cytarabine 2000 mg/sqm in 3-hours infusion every 12 hours iv day 2 of every cycles * Dexamethasone 40 mg day 1-4 of every cycles * Pegfilgrastim 6 mg sc single dose 24 hours after the end of chemotherapy or G-CSF from day 4 till stem cell harvest during mobilization's course (II o III cycle GA101-DHAP) * GA101 1000 mg iv 24 hours before apheresis as purging in vivo during second courses of therapy

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Maurizio Martelli, MD · Dipartimento di Biotecnologie Cellulari ed Ematologia, "La Sapienza" Roma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-05
Primary Completion
2018-02-28
Completion
2020-06-23

Countries

  • Italy

Study Locations

More Related Trials

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 NCT02374424 on ClinicalTrials.gov