Bendamustine, Carboplatin and Dexamethasone (BCD) for Refractory or Relapsed Peripheral T-cell Lymphoma

NCT02424045 | Completed Phase 2

• 1 other identifier: 2014-12-012
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  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

  3 years

Secondary Outcomes (4)

• Toxicity profiles (Adverse Events and Laboratory Results)

  3 years

• Progression free survival

  3 years

• Overall survival

  3 years

• Incidence of febrile neutropenia

  3 years

Study Arms (1)

BCD chemotherapy

OTHER

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

Drug: BCD chemotherapy (Bendamustine, Carboplatin, Dexamethasone)

Interventions

BCD chemotherapy (Bendamustine, Carboplatin, Dexamethasone) DRUG

All patients are scheduled to receive 2 cycles of three-weekly BCD. After 2 cycles of BCD, if the patients with complete remission (CR) or partial remission (PR) would be eligible for autologous stem cell transplantation (ASCT), stem cell collection after 3rd cycle of BCD and high dose chemotherapy and ASCT will be conducted. While ineligible patients to ASCT with non-progressive disease after 2 cycles of BCD, will be given 4 additional courses of the BCD regimen.

Also known as: BCD chemotherapy

BCD chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven aggressive T-cell Non-Hodgkin's lymphoma (NHL)
• Age 18 -75 years
• Ann Arbor stage II, III and IV (Appendix A)
• Relapsed or refractory cases to previous treatments
• Performance status (ECOG) ≤ 2 (Appendix B)
• 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
• Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2DECHO without clinically significant abnormalities
• Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L)
• 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)
• 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
• 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.

You may not qualify if:

• ALK-positive anaplastic large cell lymphoma and Sezary syndrome.
• CNS or testis involvement.
• Previously treated with the regimen containing bendamustine or platinum agents.
• Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• Other serious illness or medical conditions
• Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
• History of significant neurologic or psychiatric disorders including dementia or seizures
• Active uncontrolled infection (viral, bacterial or fungal infection)
• Other serious medical illnesses
• Known hypersensitivity to any of the study drugs or its ingredients
• Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.

Sponsors & Collaborators

• Samsung Medical Center: lead

Related Publications (1)

• Park 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 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

Bendamustine Hydrochloride; Carboplatin; Dexamethasone

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coordination Complexes; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 22, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 6, 2018

Record last verified: 2018-09