Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This is a non-randomised trial with two phases. Phase 1 involves around 20-40 participants being subsequently enrolled into 2 different dose ascending cohorts. An additional 10-20 participants may be enrolled to further explore a selected dose defined by dose escalation cohorts. After the recommended phase 2 dose (RP2D) is defined, a phase 2 dingle-arm, open-label pivotal study will be conducted to assess anti-tumour efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL.
Conditions
This trial is treating people with relapsed or refractory peripheral T-Cell lymphoma
Eligibility
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.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Dizal Pharmaceuticals
Scientific Title
A Phase I/II, Open-Label, Multicentre Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4205 in Patients With Peripheral T Cell Lymphoma (PTCL)
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