Non Hodgkin Lymphoma
Conditions
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)
Interventions
DRUGR-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
Sponsors
Fondazione Italiana Linfomi - ETS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event free survival EFS | 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. |
| Treatment related mortality TRM | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Complete Remission (CR) rate | 48 months (at the end of therapy) | — |
| Immunologic evaluation | 54 months | Rating basic immunology and 6 months after therapy high doses (lymphocyte subpopulations and Ig subclasses) |
| 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) |
| Overall Survival (OS) | 48 months (at the end of therapy) | — |
Countries
Italy
Outcome results
None listed