Status:
COMPLETED
Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)
Lead Sponsor:
Dizal Pharmaceuticals
Conditions:
Relapsed or Refractory Peripheral T Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Obtained written informed consent
- Patients must have histologically confirmed peripheral T-cell lymphoma according to the 2016 revision of the World Health Organization classification 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.
Exclusion
- Any unsolved toxicity \> Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia).
- Active infections, active or latent tuberculosis.
- Patients with severely decreased lung function.
- History of heart failure or QT interval prolongation.
- Central nervous system (CNS) or leptomeningeal lymphoma.
- History of treatment with Janus kinase (JAK) or signal transducer and activator of transcription 3 (STAT3) inhibitor.
- Patient has undergone an allogeneic stem cell transplant. Patient had autologous stem cell transplant within 6 months.
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT04105010
Start Date
September 10 2019
End Date
February 22 2024
Last Update
April 4 2025
Active Locations (50)
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1
Yale Cancer Center
New Haven, Connecticut, United States, 06510
2
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030