Phase II of High-dose Therapy in Elderly Patients With Relapsed Aggressive NHL or Resistant to First Line Therapy

April 24, 2018 updated by: Fondazione Italiana Linfomi ONLUS

A Phase II Prospective Study of High-dose Myeloablative Therapy, With Stem Cell Devices Support in Elderly Patients (≥65 and ≤ 75 Years) With Relapsed Aggressive Non-Hodgkin Lymphoma or Resistant to First Line Therapy

A phase II prospective, non-randomized study. The study aim is to evaluate the feasibility and activity of high-dose therapy with stem cell in elderly patients with aggressive lymphoma relapsed FIT or resistant to first line therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study aim is to evaluate the toxicity and activity of a therapeutic approach to high doses with support of peripheral blood stem cells (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to therapy first line in terms of event free survival (EFS) and treatment related mortality (TRM)

Study Type

Interventional

Enrollment (Anticipated)

135

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rimini, Italy, 47923
        • Recruiting
        • Ospedale Degli Infermi
        • Principal Investigator:
          • Anna Lia Molinari, MD
        • Contact:
    • AL
      • Alessandria, AL, Italy, 15121
        • Recruiting
        • A.O. SS.Antonio e Biagio e C. Arrigo
        • Contact:
    • AN
      • Ancona, AN, Italy, 60126
        • Recruiting
        • Ospedali Riuniti
        • Contact:
    • BR
      • Brindisi, BR, Italy, 72100
        • Active, not recruiting
        • Ospedale Perrino
    • BS
    • CT
      • Catania, CT, Italy, 95123
        • Active, not recruiting
        • Policlinico Vittorio Emanuele
    • FG
      • San Giovanni Rotondo, FG, Italy, 71013
        • Active, not recruiting
        • Casa Sollievo della Sofferenza
    • Forlì-Cesena
      • Meldola, Forlì-Cesena, Italy, 47014
    • GE
      • Genova, GE, Italy, 16132
        • Active, not recruiting
        • IRCCS San Martino - IST
    • MC
      • Civitanova Marche, MC, Italy, 62012
        • Active, not recruiting
        • ASUR Marche, Area Vasta 3
    • ME
      • Messina, ME, Italy, 98158
        • Recruiting
        • AO Riuniti Papardo Piemonte
        • Principal Investigator:
          • Donato Mannina, MD
        • Contact:
    • MI
    • Milano
      • Rozzano, Milano, Italy, 20089
    • PC
      • Piacenza, PC, Italy, 29100
        • Recruiting
        • Ospedale Civile "Guglielmo da Saliceto"
        • Contact:
        • Principal Investigator:
          • Danilele Vallisa, MD
    • PN
      • Aviano, PN, Italy, 33081
        • Recruiting
        • Centro di Riferimento Oncologico
        • Contact:
        • Principal Investigator:
          • Mariagrazia Michieli, MD
    • PR
      • Parma, PR, Italy, 43126
        • Recruiting
        • Azienda Ospaliero Universitaria di Parma
        • Contact:
          • Francesca Re, MD
          • Phone Number: 0521-033306
          • Email: fre@ao.pr.it
        • Principal Investigator:
          • Francesca Re, Prof.
    • PZ
      • Potenza, PZ, Italy, 85100
        • Active, not recruiting
        • Ospedale San Carlo
    • RA
      • Ravenna, RA, Italy, 48100
        • Recruiting
        • AUSL di Ravenna
        • Principal Investigator:
          • Monica Tani, MD
        • Contact:
    • RC
      • Reggio Calabria, RC, Italy, 89125
        • Active, not recruiting
        • A.O. Bianchi - Melacrino - Morelli
    • RE
      • Reggio Emilia, RE, Italy, 43123
    • RM
      • Roma, RM, Italy, 00189
        • Recruiting
        • Policlinico Sant'Andrea
        • Principal Investigator:
          • Maria Christina Cox, MD
        • Contact:
    • SA
      • Nocera Inferiore, SA, Italy, 84014
        • Active, not recruiting
        • Ospedale Nocera- Pagani
      • Salerno, SA, Italy, 84131
        • Active, not recruiting
        • AOU San Giovanni e Ruggi
    • TO
      • Torino, TO, Italy, 10126
        • Recruiting
        • AOU Città della Salute e della Scienza
        • Principal Investigator:
          • Federica Cavallo, MD
        • Contact:
      • Torino, TO, Italy, 10128
        • Active, not recruiting
        • Ospedale Mauriziano
    • TR
      • Terni, TR, Italy, 05100
        • Active, not recruiting
        • AO Santa Maria
    • VC
      • Vercelli, VC, Italy, 13100
        • Active, not recruiting
        • Ospedale S.Andrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of NHL
  • relapse and refractory pts
  • age ≥ 65 and ≤75
  • ECOG performance status <2
  • FIT patients (Instrumental Activity of Daily Living (IADL)=8, Activity of Daily Living (ADL)=6, Cumulative Illness Rating Scale (CIRS) =0 SCORE=3-4, <5 SCORE=2 )
  • evaluable disease
  • no RT since 3 week
  • absolute neutrophil count >= 1500/mm3 and platelets >= 100.000/106L
  • Creatinin <= 1.5 mg/dL and clearance >40 ml/min/24 h
  • bilirubins < =2 mg/dL
  • forced expiratory volume >50% - arterial pressure O2 >70 mmHg
  • no other neoplastic disease
  • Life expectancy> 3 months
  • signed informed consent

Exclusion Criteria:

  • HBV+ - HCV+ - HIV+
  • NSC involvement - medullar infiltration > 20%
  • other chemotherapy or radiotherapy
  • cardiac disease
  • alteration of liver and kidney function
  • infections
  • demented patient
  • no compliance and depressed pts
  • Frail and Unfit pts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R-DHAP/R-ICE
High-dose myeloablative therapy (R-DHAP or R-ICE) and conditioning therapy (BEAM or FEAM) in elderly patients with relapsed NHL or resistant to firs line therapy
Drug: R-DHAP/R-ICE

R-DHAP/R-ICE 3 cycles every 21 days:

  1. R-DHAP

    • Rituximab 375 mg/m2, e.v. day 1
    • Desamethasone 40 mg days 1-4
    • cis-Platino100 mg/m2, day 2 (if ≥70 years 75 mg/m2)
    • Aracytin 2000 mg/m2, e.v. day 3 (if ≥70 years 1500 mg/m2)

  2. R-ICE

    • Rituximab 375 mg/m2, e.v. day 1
    • Etoposide 100 mg/mq, e.v. days 1,2,3 (if ≥70 years 75 mg/mq)
    • Ifosfamide with Mesna equidone 5000 mg/mq, day 2 (if ≥70 years 3750 mg/mq)
    • Carboplatino AUC=5, e.v. (max 800 mg/mq), day 2 (if ≥70 years AUC=4)

Conditioning BEAM or FEAM

Other Names:
  • R-DHAP or R-ICE and BEAM or FEAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event free survival EFS
Time Frame: 36 months
Evaluate the toxicity and activity of a therapeutic approach to high doses with stem cell support device (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to 1st line therapy in terms of EFS.
36 months
Treatment related mortality TRM
Time Frame: 100 days from the high doses
Evaluate the toxicity and activity of a therapeutic approach to high doses with stem cell support device (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to 1st line therapy in terms of TRM.
100 days from the high doses

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Remission (CR) rate
Time Frame: 48 months (at the end of therapy)
48 months (at the end of therapy)
Overall Survival (OS)
Time Frame: 48 months (at the end of therapy)
48 months (at the end of therapy)
Adverse events incidence evaluation (grade III or IV)
Time Frame: 48 months (at the end of therapy)
Number of participants with adverse events (grade III or IV)
48 months (at the end of therapy)
Quality of Life (QoL)
Time Frame: 54 months
Evaluate the quality of life (QoL) before, after therapy rescue and after six months of high-dose therapy through the quality of life questionnaire of European Organization for Research and Treatment of Cancer (EORTC QLQ-C30)
54 months
Immunologic evaluation
Time Frame: 54 months
Rating basic immunology and 6 months after therapy high doses (lymphocyte subpopulations and Ig subclasses)
54 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Investigators

  • Principal Investigator: Luca Castagna, MD, IRCCS Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_RecAnz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Hodgkin Lymphoma

Clinical Trials on R-DHAP/R-ICE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe