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

Non Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02371161
• Other study ID #: FIL_RecAnz
• Status: Recruiting
• Phase: Phase 2
• First received: February 11, 2015
• Last updated: April 24, 2018
• Start date: February 2014
• Est. completion date: February 2023

Study information

• Verified date: April 2018
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: February 2023
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Intervention

Drug:
• R-DHAP/R-ICE
R-DHAP/R-ICE 3 cycles every 21 days: 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) 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

Locations

Country	Name	City	State
Italy	A.O. SS.Antonio e Biagio e C. Arrigo	Alessandria	AL
Italy	Ospedali Riuniti	Ancona	AN
Italy	Centro di Riferimento Oncologico	Aviano	PN
Italy	Spedali Civili	Brescia	BS
Italy	Ospedale Perrino	Brindisi	BR
Italy	Policlinico Vittorio Emanuele	Catania	CT
Italy	ASUR Marche, Area Vasta 3	Civitanova Marche	MC
Italy	IRCCS San Martino - IST	Genova	GE
Italy	IRST Meldola	Meldola	Forlì-Cesena
Italy	AO Riuniti Papardo Piemonte	Messina	ME
Italy	AO Niguarda Ca' Granda	Milano	MI
Italy	Ospedale Nocera- Pagani	Nocera Inferiore	SA
Italy	Azienda Ospaliero Universitaria di Parma	Parma	PR
Italy	Ospedale Civile "Guglielmo da Saliceto"	Piacenza	PC
Italy	Ospedale San Carlo	Potenza	PZ
Italy	AUSL di Ravenna	Ravenna	RA
Italy	A.O. Bianchi - Melacrino - Morelli	Reggio Calabria	RC
Italy	Asmn-Irccs	Reggio Emilia	RE
Italy	Ospedale degli Infermi	Rimini
Italy	Policlinico Sant'Andrea	Roma	RM
Italy	IRCCS Humanitas	Rozzano	Milano
Italy	AOU San Giovanni e Ruggi	Salerno	SA
Italy	Casa Sollievo della Sofferenza	San Giovanni Rotondo	FG
Italy	AO Santa Maria	Terni	TR
Italy	AOU Città della Salute e della Scienza	Torino	TO
Italy	Ospedale Mauriziano	Torino	TO
Italy	Ospedale S.Andrea	Vercelli	VC

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival EFS	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
Primary	Treatment related mortality TRM	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	Complete Remission (CR) rate		48 months (at the end of therapy)
Secondary	Overall Survival (OS)		48 months (at the end of therapy)
Secondary	Adverse events incidence evaluation (grade III or IV)	Number of participants with adverse events (grade III or IV)	48 months (at the end of therapy)
Secondary	Quality of Life (QoL)	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
Secondary	Immunologic evaluation	Rating basic immunology and 6 months after therapy high doses (lymphocyte subpopulations and Ig subclasses)	54 months