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

Phase 2
Conditions
Non Hodgkin Lymphoma
Interventions
Drug: R-DHAP/R-ICE
Registration Number
NCT02371161
Lead Sponsor
Fondazione Italiana Linfomi - ETS
Brief Summary

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.

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)

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
135
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
R-DHAP/R-ICER-DHAP/R-ICEHigh-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
Primary Outcome Measures
NameTimeMethod
Event free survival EFS36 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.

Treatment related mortality TRM100 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.

Secondary Outcome Measures
NameTimeMethod
Complete Remission (CR) rate48 months (at the end of therapy)
Overall Survival (OS)48 months (at the end of therapy)
Immunologic evaluation54 months

Rating basic immunology and 6 months after therapy high doses (lymphocyte subpopulations and Ig subclasses)

Adverse events incidence evaluation (grade III or IV)48 months (at the end of therapy)

Number of participants with adverse events (grade III or IV)

Quality of Life (QoL)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)

Trial Locations

Locations (27)

IRST Meldola

🇮🇹

Meldola, Forlì-Cesena, Italy

Centro di Riferimento Oncologico

🇮🇹

Aviano, PN, Italy

Azienda Ospaliero Universitaria di Parma

🇮🇹

Parma, PR, Italy

Ospedale San Carlo

🇮🇹

Potenza, PZ, Italy

Ospedale Nocera- Pagani

🇮🇹

Nocera Inferiore, SA, Italy

Ospedale S.Andrea

🇮🇹

Vercelli, VC, Italy

Ospedale Perrino

🇮🇹

Brindisi, BR, Italy

AOU Città della Salute e della Scienza

🇮🇹

Torino, TO, Italy

AO Santa Maria

🇮🇹

Terni, TR, Italy

Policlinico Vittorio Emanuele

🇮🇹

Catania, CT, Italy

ASUR Marche, Area Vasta 3

🇮🇹

Civitanova Marche, MC, Italy

A.O. SS.Antonio e Biagio e C. Arrigo

🇮🇹

Alessandria, AL, Italy

Spedali Civili

🇮🇹

Brescia, BS, Italy

Casa Sollievo della Sofferenza

🇮🇹

San Giovanni Rotondo, FG, Italy

AUSL di Ravenna

🇮🇹

Ravenna, RA, Italy

Asmn-Irccs

🇮🇹

Reggio Emilia, RE, Italy

Policlinico Sant'Andrea

🇮🇹

Roma, RM, Italy

AOU San Giovanni e Ruggi

🇮🇹

Salerno, SA, Italy

Ospedali Riuniti

🇮🇹

Ancona, AN, Italy

IRCCS San Martino - IST

🇮🇹

Genova, GE, Italy

AO Riuniti Papardo Piemonte

🇮🇹

Messina, ME, Italy

AO Niguarda Ca' Granda

🇮🇹

Milano, MI, Italy

Ospedale Mauriziano

🇮🇹

Torino, TO, Italy

IRCCS Humanitas

🇮🇹

Rozzano, Milano, Italy

Ospedale Civile "Guglielmo da Saliceto"

🇮🇹

Piacenza, PC, Italy

A.O. Bianchi - Melacrino - Morelli

🇮🇹

Reggio Calabria, RC, Italy

Ospedale degli Infermi

🇮🇹

Rimini, Italy

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