Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral 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
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
Treatments tested in this trial
- XNW5004 combined with CHOP (incremental)
- XNW5004 combined with CHOEP (incremental)
- XNW5004 combined with CHOP (extended)
- XNW5004 combined with CHOEP (extended)
Treatment groups
176 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov