Clinical trial · Interventional
Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma
Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study "BENTLY"
NCT00959686CI-TRIAL-00009432BENTLYcompletedPhase 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 clinical study to determine the efficacy of single agent Bendamustine for T cell lymphoma "BENTLY".
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 |
|---|---|---|---|
| T-cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bendamustine
- description
- Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles
- interventionNames
- Drug: Bendamustine
Primary outcomes (1)
- measure
- Determine the overall response rate (ORR) (CR+CRu+PR)
- timeFrame
- 36 months follow-up
Secondary outcomes (2)
- measure
- Evaluation of the tolerance and Safety of bendamustine in this subset of patients
- timeFrame
- 36 months follow-up
- measure
- Determination of the progression free survival (PFS), time to treatment failure (TTF), time to progression (TTP), overall survival (OS) and the duration of response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged more than 18 years. * Refractory or relapsed peripheral T-cell NHL (PTCL) * Cutaneous T cell lymphoma (CTCL) in relapse or refractory to topical therapy * ECOG score less than 2 * No major organ dysfunction unrelated to lymphoma. Exclusion Criteria: * Pregnant or breast feeding women * ECOG score \> 2 * Estimate survival time \< 3 months * Active infection or severe organ dysfunction or psychiatric condition that unable patients to receive chemotherapy * Creatinine clearance \< 10 ml/min or severe hepatic dysfunction not related to lymphoma. * Previous chemotherapy/immunotherapy within 3 weeks before study entry * Known seropositive for or active viral infection HIV, EBV, HCV * CNS lymphoma * T-cell Leukemia lymphoma associated with HTLV1 * Sezary syndrome
References
Publications (1)
- DERIVEDDamaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Bene MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. doi: 10.1200/JCO.2012.43.7285. Epub 2012 Oct 29. PMID 23109692