Genotype-guided Treatment in Newly Diagnosed PTCL
Recruiting
Phase 1
Phase 2
Interventional Study
Peripheral T Cell Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 264 (estimated)
- Sponsor
- Ruijin Hospital · Other
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About This Trial
This study includes Phase I and Phase II stages. Phase I is an open-label trial to confirm RP2D of oral targeted agents in three genetic subtypes. Phase II is a multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP-X2) versus cyclophosphamide, do…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologically-confirmed Peripheral T-cell lymphoma
* Availability of archival or freshly collected tumor tissue before study enrollment enough for NGS
* Evaluable lesion by PET-CT or CT scan
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Life e…
Contacts