Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
18 Years and older, Male and Female
DZ2019J0005 (primary)
NCI-2021-03769
Summary
This is a multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the
safety, tolerability and anti-tumor efficacy of AZD4205 as monotherapy in patients with
peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to
standard systemic treatment.
Phase 1 part:
Around 20~40 patients will be subsequently enrolled into 2 different dose ascending cohorts.
Additional 10~20 patients may be enrolled to further explore a selected dose defined by dose
escalation cohorts.
Phase 2 part:
After the recommended phase 2 dose (RP2D) is defined, a phase 2 single-arm open-label pivotal
study will be conducted to assess anti-tumor efficacy and safety of AZD4205 at RP2D in
patients with refractory or relapsed PTCL.
Eligibility
- Obtained written informed consent
- Patients must have histologically confirmed peripheral T-cell lymphoma according to the 2016 revision of the World Health Organization classi?cation of lymphoid neoplasms. Tumor samples are required for central pathology review to confirm the diagnosis.
- Patients must have measurable disease according to the Lugano criteria.
- Patients should be transplant-ineligible upon their entry into this study, and must have relapsed after or been refractory/intolerant to = 1 (but not > 3) prior systemic therapy(ies) for PTCL.
- Adequate bone marrow reserve and organ system functions.
Treatment Sites in Georgia
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