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

Fondazione Italiana Linfomi - ETS135 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

135

Conditions

Non Hodgkin Lymphoma

Interventions

R-DHAP/R-ICEDRUG

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

Eligibility

Sex: ALLMin age: 65 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (27)

Outcomes

Primary Outcomes

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.

Time frame: 36 months

Treatment related mortality TRM

Time frame: 100 days from the high doses

Secondary Outcomes

Complete Remission (CR) rate

Time frame: 48 months (at the end of therapy)

Overall Survival (OS)

Time frame: 48 months (at the end of therapy)

Adverse events incidence evaluation (grade III or IV)

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

Time frame: 48 months (at the end of therapy)

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)

Time frame: 54 months

Immunologic evaluation

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

Time frame: 54 months

Data from ClinicalTrials.gov

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