A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype

Phase 3

Not yet recruiting

• Conditions: Lymphoma
• Interventions: Drug: Duvelisib; Drug: Gemcitabine; Drug: Bendamustine

• Registration Number: NCT06522737
• Lead Sponsor: SecuraBio

Brief Summary

The study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed/refractory nodal T cell lymphoma with TFH phenotype.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Related News

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Study Start: 2025-03
• Primary Completion: 2028-02
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Pathologically confirmed nodal T cell lymphoma with TFH phenotype according to the criteria of the World Health Organization classification (Swerdlow 2017, Alaggio 2022) including any one of Angioimmunoblastic T cell lymphoma (AITL), follicular T cell lymphoma, and other nodal peripheral T cell lymphoma (PTCL) with a TFH phenotype.
• Relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for T cell lymphoma.
• Measurable disease as defined by Lugano 2014 criteria (Cheson 2014) for T cell lymphoma.

Key

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Exclusion Criteria

• Cutaneous-only disease.
• Received prior allogeneic transplant any time in the past or received autologous transplant within 60 days prior to the first dose of study drug.
• Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor.
• Prior exposure to planned study treatment investigator's choice therapy (gemcitabine or bendamustine) within 60 days prior to the first dose of study drug.

Other protocol-defined criteria apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duvelisib	Duvelisib	Duvelisib will be administered orally twice daily (BID) in 28-day cycles.
Gemcitabine or Bendamustine	Gemcitabine	Participants will receive the investigator's choice of gemcitabine or bendamustine. The regimen to be used after randomization must be selected by the investigator prior to randomization. Gemcitabine will be administered intravenously (IV) on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. Bendamustine will be administered IV on days 1 and 2 of each 21-day cycle for up to 6 cycles.
Gemcitabine or Bendamustine	Bendamustine	Participants will receive the investigator's choice of gemcitabine or bendamustine. The regimen to be used after randomization must be selected by the investigator prior to randomization. Gemcitabine will be administered intravenously (IV) on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. Bendamustine will be administered IV on days 1 and 2 of each 21-day cycle for up to 6 cycles.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events (AEs)	Up to 3 years
Complete Response Rate (CRR) as assessed by the IRC	Up to 3 years
Duration of Response (DOR) as assessed by the IRC	Up to 3 years
Proportion of participants who proceed to Stem Cell Transplantation (SCT)	Up to 3 years
Investigator-assessed PFS in participants who proceed to SCT	Up to 3 years
Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score	Up to 3 years
QoL: EQ5D Score	Up to 3 years
QoL: QLQ-NHL-HG29 Score	Up to 3 years
Overall Survival (OS)	Up to 3 years
PFS as assessed by the investigator	Up to 3 years
Objective Response Rate (ORR) as assessed by the IRC	Up to 3 years