Health TrialsbyHealthPanel

Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma

ConditionsNon-hodgkin LymphomaPeripheral T-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEvopoint Biosciences Inc.

About this trial

In this study, the XNW5004 tablets combined with CHOP/CHOEP will be used for the treatment of newly diagnosed PTCL patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years (inclusive); both genders are eligible.

Pathologically confirmed peripheral T-cell lymphoma (PTCL).

No prior systemic anti-PTCL therapy.

At least one measurable lesion as the basis for evaluation: nodal lesions with a long diameter > 1.5 cm; extranodal lesions with a long diameter > 1.0 cm.

Disqualifiers

Prior treatment with any anti-tumor therapy, including but not limited to: chemotherapy, immunotherapy, radiotherapy, targeted therapy, anti-tumor traditional Chinese medicine, or anti-tumor investigational drugs.

Subjects with known hypersensitivity to the investigational drug or its active ingredients or excipients.

Subjects who have undergone major surgery within 4 weeks prior to the first dose of the investigational drug, or who plan to undergo major surgery during the study period (except for procedures such as puncture or lymph node biopsy).

Prior or planned allogeneic hematopoietic stem cell transplantation or solid organ transplantation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • XNW5004 combined with CHOP (incremental)

    Drug

    The XNW5004 protocol has preset four dosage groups: 400mg, 800mg, 1200mg and 1600mg, administered twice daily (BID). The CHOP regimen is administered at a fixed dose, for a total of 6 cycles. After completing the combined treatment and without disease progression, the subjects will continue to receive XNW5004 at 1200mg BID for maintenance therapy.

  • XNW5004 combined with CHOEP (incremental)

    Drug

    It is expected to conduct dose escalation studies for XNW5004 in combination with CHOEP using 1-3 dose groups. The CHOEP regimen will be administered at a fixed dose for a total of 6 cycles. After completing the combined treatment and without disease progression, the subjects will continue to receive XNW5004 at 1200mg BID for maintenance therapy.

  • XNW5004 combined with CHOP (extended)

    Drug

    Those who received the combination treatment of XNW5004 and CHOP, and who did not experience disease progression after the combined treatment, will continue to receive maintenance treatment with XNW5004 at a dose of 1200mg twice daily.

  • XNW5004 combined with CHOEP (extended)

    Drug

    Those who received the combination treatment of XNW5004 and CHOEP, and who did not experience disease progression after the combined treatment, will continue to receive maintenance treatment with XNW5004 at a dose of 1200mg twice daily.

Treatment groups

176 Participants
are divided into 4 treatment groups
Group A: Ib stage,Cohort1Experimental treatment 1 intervention
Group B: Ib stage,Cohort2Experimental treatment 1 intervention
Group C: Phase II, dose expansion stage,CHOPExperimental treatment 1 intervention
Group D: Phase II, dose expansion stage,CHOEPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ib/II:Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability].

Incidence and severity of adverse events that are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Time frame
through study completion, an average of 1 year
2

II：Objective response rate (ORR)

ORR is defined as the proportion of subjects who have a confirmed CR or a PR per lugano2014 assessed by Investigator.

Time frame
36 months
3

Ib:Maximum tolerated dose (MTD) and/or the recommended Part 2 dose

To determine the maximum tolerated dose (MTD) and the recommended Part 2 dose with XNW5004.

Time frame
The first 21-day cycle of therapy

Secondary outcomes

1

Ib/II:The maximum (peak) blood drug concentration (Cmax) is XNW5004

Collect blood samples at the specified intervals to determine the Cmax.

Time frame
through study completion, an average of 1 year
2

Ib/II：XNW5004 Peak Time (Tmax)

Collect blood samples at the specified intervals to determine the Tmax.

Time frame
through study completion, an average of 1 year
3

Ib/II：The area under the blood drug concentration-time curve of XNW5004 (AUC)

Collect blood samples at specified intervals to determine AUC

Time frame
through study completion, an average of 1 year
4

Ib/II:The maximum (peak) blood drug concentration in the steady state (Css,max)

Collect blood samples at specified intervals to determine Css,max

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Evopoint Biosciences Inc.

Lead sponsor

Source ClinicalTrials.gov
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