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B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T-cell Lymphoma

NCT03246750 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-04-17

No results posted yet for this study

Summary

Study Title: Phase I/II study of brentuximab vedotin and methotrexate/ L-asparaginase/ dexamethasone (B-MAD) chemotherapy in patients with newly-diagnosed Extranodal NK/T-cell Lymphoma

Phase: I/II

Number of Patients: 36

Study Objectives

Primary

* To determine the safety and optimal dose of brentuximab vedotin when use in combination with methotrexate, L-asparaginase and dexamethasone in the treatment of newly-diagnosed ENKTL patients

Secondary

* To evaluate the clinical efficacy of this regimen
* To access the overall responses including overall response rate (ORR), disease-free survival (DSF), progression-free survival (PFS).

Overview of Study Design:

Open-label, multicenter, non-randomized, 3+3 dose escalation study of brentuximab vedotin in combination with fixed-dose MAD chemotherapy. The first cycle will be evaluated for the determination of the recommended phase II dose.

Patients will be received the treatment according to the stage of disease as follows:

* Patients with localized ENKTL (stage IE or stage IIE) will receive involved-field radiation (IRFT) with concomitant weekly intravenous Cisplatin. Three to five weeks after the completion of IFRT and cisplatin, B-MAD (Brentuximab vedotin, Methotrexate, L-asparaginase and Dexamethasone) regimen will be given every 21 days for 3 cycles.
* Patients with advanced ENKTL (stage III or stag IV) will receive B-MAD every 21 days for 6 cycles.

Study Population:

Patients with newly-diagnosed ENKTL will be screened for enrollment.

Duration of Study: 3 years

Conditions

  • Extranodal NK/T-cell Lymphoma

Interventions

DRUG

B-MAD chemotherapy

B-MAD chemotherapy

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • The Thai Lymphoma Study Group

    lead OTHER

Principal Investigators

  • Udomsak Bunworasate, MD · Chulalongkorn University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2024-04-10
Completion
2024-04-10

Countries

  • Thailand

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246750 on ClinicalTrials.gov