AZD4205 in Relapsed or Refractory Peripheral T Cell Lymphoma (JACKPOT27) (NCT06511895) | Clinical Trial Compass
CompletedPhase 2
AZD4205 in Relapsed or Refractory Peripheral T Cell Lymphoma (JACKPOT27)
China57 participantsStarted 2022-05-31
Plain-language summary
This is a phase II, open label, multicenter study of AZD4205 administered orally in participants with r/r PTCL to determine its safety, tolerability, PK, and anti-tumor activity. Eligible participants are those who had pathologically confirmed PTCL and have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen. The primary objective of this study is to evaluate anti-tumor efficacy of AZD4205 at 150 mg once daily (RP2D) in participants with r/r PTCL. The safety, tolerability, and PK of AZD4205 in r/r PTCL at RP2D will also be investigated.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
β. β₯ 18 years old (for Korean β₯ 19 years old)
β. ECOG performance status 0-2 with no deterioration over the previous 2 weeks
β. Predicted life expectancy β₯ 12 weeks.
β. Histologically confirmed PTCL by local pathology review according to the 2016 revision of the WHO classiο¬cation of lymphoid neoplasms. Eligible histological subtypes are restricted to the following:
β. Have measurable disease according to the 2014 Lugano classification
β. Must have progressed on or are refractory to standard systemic therapy, or patients were intolerant to standard systemic therapy. Participants should be transplant-ineligible upon their entries to this study.
β. Adequate bone marrow reserve and organ system functions
β. LVEF β₯ 55% assessed by ECHO or MUGA.
Exclusion criteria
β. Intervention with any of the following:
What they're measuring
1
Objective response rate (ORR) assessed by investigators per Lugano criteria
. Any unresolved toxicities from prior therapy, greater than CTCAE v 5.0 Grade 1 at the time of starting study treatment with the exception of alopecia.
β. Central nervous system or leptomeningeal lymphoma.
β. With severely decreased lung function (i.e. any parameter of FEV1, and DLCO \< 60% of predicted value). Past medical history of pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
β. With disease condition which requires the treatment of immunosuppressants, biologics, or NSAIDs (non-steroid anti-inflammatory drugs).
β. Active infections including:
β. Any of the following cardiac criteria:
β. Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.