Clinical trial · Interventional
Phase II of High-dose Therapy in Elderly Patients With Relapsed Aggressive NHL or Resistant to First Line Therapy
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
NCT02371161CI-TRIAL-00032658unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-DHAP/R-ICE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-DHAP/R-ICE
- description
- 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
- interventionNames
- Drug: R-DHAP/R-ICE
Primary outcomes (2)
- measure
- Event free survival EFS
- timeFrame
- 36 months
- description
- 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.
- measure
- Treatment related mortality TRM
- timeFrame
- 100 days from the high doses
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTucci A, Re A, Pagani C, Marcheselli L, Marcheselli R, Malaspina F, Cavallo F, Zilioli VR, Zanni M, Mannina D, Michieli M, Arcari A, Castagna L, Musuraca G, Clerico M, Merli F, Tani M, Re F, Gini G, Rotondo F, Turrini M, Rossi G, Cox MC. A phase 2 study of autologous stem cell transplantation as salvage therapy for older patients with aggressive B-cell lymphoma prospectively evaluated by comprehensive geriatric assessment: the FIL_RECANZ study. Leuk Lymphoma. 2025 Jul;66(7):1284-1292. doi: 10.1080/10428194.2025.2471499. Epub 2025 Mar 8. PMID 40055982