Clinical trial · Interventional
Bendamustine, Carboplatin and Dexamethasone (BCD) for Refractory or Relapsed Peripheral T-cell Lymphoma
A Phase II Trial of Bendamustine, Carboplatin and Dexamethasone (BCD) for Refractory or Relapsed Peripheral T-cell Lymphoma: BENCART Trial
- 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)
BCD (Bendamustine, carboplatin and dexamethasone)chemotherapy regimen is proposed as the salvage treatment for relapsed or refractory PTCLs in this study protocol, which would be expected to show more promising clinical outcomes than that of bendamustine single therapy. Platinum combination with bendamustine is a theoretically ideal salvage regimen for the patients of PTCLs because these both agents are highly effective drugs in lymphoma treatment and have rare cross-resistance. Carboplatin was selected as a platinum agent for combination with bendamustine, which is a second generation platinum agent and has a less neurotoxicity than that of cisplatin, considering use for previously treated patients with vinc alkaloid agents. In a prior phase I study of carboplatin in combination with bendamustine for previously untreated small cell lung cancer patients, the recommended dose for phase II studies was bendamustine 100 mg/m2 on day 1 and 2, carboplatin AUC 5 on day 1, respectively \[16\]. In consideration of previously treated subjects, however, the dose of bendamustine was decided on 80mg/m2 in this study protocol with concerning about the toxicities, especially to severe cytopenia. Dexamethasone is one of the corticosteroids using a key drug for lymphoid malignancy and has a strong antiemetic effect. Therefore, dexamethasone could enhance the therapeutic efficacy and antiemetic effect, using with bendamustine and carboplatin.
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 |
|---|---|---|---|
| BCD chemotherapy (Bendamustine, Carboplatin, Dexamethasone) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- BCD chemotherapy
- description
- All patients are scheduled to receive 2 cycles of three-weekly Bendamustine, carboplatin and dexamethasone combination chemotherapy(BCD Chemotherapy). D1,D2 Bendamustine 80mg/m2 IV over 30-60min D1 Carboplatin AUC 5.0 IV D1-4 Dexamethasone 40mg #2 PO or IV
- interventionNames
- Drug: BCD chemotherapy (Bendamustine, Carboplatin, Dexamethasone)
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 3 years
- description
- They should be classified as complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to the Revised Response Criteria for Malignant Lymphoma
Secondary outcomes (4)
- measure
- Toxicity profiles (Adverse Events and Laboratory Results)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven aggressive T-cell Non-Hodgkin's lymphoma (NHL) 2. Age 18 -75 years 3. Ann Arbor stage II, III and IV (Appendix A) 4. Relapsed or refractory cases to previous treatments 5. Performance status (ECOG) ≤ 2 (Appendix B) 6. At least one or more bidimensionally measurable lesion(s) * ≥ 2 cm by conventional CT * ≥ 1 cm by spiral CT * skin lesion (photographs should be taken) ≥ 2 cm * measurable lesion by physical examination ≥ 2 cm 7. Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2DECHO without clinically significant abnormalities 8. Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L) 9. Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value (or \< 5 x ULN in the presence of DLBCL involvement of the liver), Bilirubin \< 2 X upper normal value (or \< 5 x ULN in the presence of PTCL involvement of the liver) 10. Adequate BM functions: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma 11. A negative serum or urine pregnancy test prior to treatment must be available both for pre-menopausal women and for women who are \< 1years after the onset of menopause. 12. Informed consent Exclusion Criteria: 1. ALK-positive anaplastic large cell lymphoma and Sezary syndrome. 2. CNS or testis involvement. 3. Previously treated with the regimen containing bendamustine or platinum agents. 4. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 5. Pregnant or lactating women, women of childbearing potential not employing adequate contraception 6. Other serious illness or medical conditions 7. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry 8. History of significant neurologic or psychiatric disorders including dementia or seizures 9. Active uncontrolled infection (viral, bacterial or fungal infection) 10. Other serious medical illnesses 11. Known hypersensitivity to any of the study drugs or its ingredients 12. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
References
Publications (1)
- DERIVEDPark BB, Kim WS, Suh C, Hong JY, Yang DH, Lee WS, Do YR, Koh YI, Won JH, Kim MK, Jo JC, Hyun SY, Kim JA, Oh YH, Lee SS. A phase II trial of bendamustine, carboplatin, and dexamethasone for refractory or relapsed peripheral T-cell lymphoma (BENCART trial). Leuk Lymphoma. 2019 Dec;60(13):3251-3257. doi: 10.1080/10428194.2019.1622100. Epub 2019 Jun 6. PMID 31170847