AZD4573 in r/r peripheral T-cell lymphoma or classical Hodgkin lymphoma

• Research type

  Research Study

• Full title

  A Modular Phase II, Open-label, Multicentre Study to Assess AZD4573 Efficacy and Safety as Monotherapy or in Combination with Anti-cancer Agents in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma or classical Hodgkin Lymphoma

• IRAS ID

  1004213

• Contact name

  Ginette Hampshire

• Contact email

  ginette.hampshire@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2021-002570-54

• Clinicaltrials.gov Identifier

  NCT05140382

• Research summary

  The aim of the study is to assess “AZD4573” in patients with relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL) or classical Hodgkin lymphoma (cHL), which are blood cancers. Module1 will assess the safety, efficacy, tolerability and pharmacokinetics (PK ) of AZD4573 as a monotherapy (used alone) in these populations.

  Currently there are 3 drugs approved by the FDA for use in all subtypes of PTCL . Historically, cHL treatment included chemo and radiotherapies in 1st line, with autologous haematopoietic stem cell transplantation (HSCT) as 2nd line treatment.
  None of these drugs provide a cure and the overall response rate is only 25% to 30%. Newer treatments for cHL approved in the US, EU and Japan demonstrate high response rates, but the majority of patients do not achieve durable remission and go on to develop progressive disease.

  AZD4573 is able to block a protein called cyclin-dependent kinase 9 (CDK9) which is involved in controlling the amounts of specific proteins such as myeloid cell leukaemia 1 (MCL1) and B-cell leukaemia line (BFL-1) which are both increased in various cancers. As a result, cancer cells that need MCL1, BFL1 or both start to die resulting in slower tumour growth or shrinkage.

  In Module 1, participants will be enrolled into one of 3 cohorts.
  All participants will receive the same study treatment (AZD4573) which will be administered via a 2-hour intravenous (IV) infusion once weekly at ascending doses in Cycle 1; then 12mg weekly thereafter. Each separate cohort will enrol 21 participants and may include up to a maximum of 30 participants. This study is expected to enrol participants globally in approximately 30 sites in about 12 to 15 countries.

  AstraZeneca AB is the Sponsor of this study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  21/LO/0886

• Date of REC Opinion

  26 Jan 2022

• REC opinion

  Further Information Favourable Opinion