Phase 2 Lymphoma Trial, Recruiting NCT07123454 Sponsor: AstraZeneca Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT07123454
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who have been diagnosed with a type of blood cancer called B-cell non-Hodgkin lymphoma (B-NHL), confirmed by a tissue biopsy and classified according to the World Health Organization's 2022 guidelines
  • In the early phase of the trial, most B-NHL subtypes may be considered (with some exceptions); in a later phase, eligible subtypes are limited to specific large B-cell lymphomas (including Diffuse Large B-Cell Lymphoma, certain high-grade lymphomas, primary mediastinal large B-cell lymphoma, and transformed indolent lymphoma) and mantle cell lymphoma
  • People whose lymphoma has come back or stopped responding to treatment after at least two previous rounds of treatment, and for whom standard treatment options with proven benefit are no longer available
  • For large B-cell lymphoma patients specifically: prior treatment must have included an anti-CD20 therapy and at least one chemotherapy regimen, and CAR-T cell therapy, T-cell engager therapy, and stem cell transplant must have been considered or ruled out as options
  • For mantle cell lymphoma patients specifically: prior treatment must have included both an anti-CD20 therapy and a BTK inhibitor
  • People whose cancer can be measured on scans using standard criteria (Lugano 2014 guidelines)
  • People who are well enough to carry out basic daily activities, as assessed using a standard medical scale (ECOG score of 0, 1, or 2)
  • People whose heart, kidneys, liver, bone marrow, and blood counts meet the health thresholds required by the trial (confirm specific values with trial site)

Who may not be able to join:

  • People diagnosed with certain related blood or lymph node conditions, including post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, Waldenström's macroglobulinemia, or lymphoplasmacytic lymphoma
  • People whose lymphoma has spread to the brain or spinal cord and is currently active
  • People who have received CAR-T cell therapy or T-cell engager therapy within the 90 days before the trial start date
  • People who have received another experimental drug or cancer treatment (other than low-dose steroids) within 21 days or 5 half-lives of the trial start date, whichever is shorter
  • People who have received high-dose radiation intended to cure their cancer within 14 days before the trial start date (localised radiation for symptom relief may be acceptable — confirm with trial site)
  • People who have had a donor stem cell transplant within 180 days, unless their condition has been stable with no active graft-versus-host disease for at least 2 months
  • People who have had their own stem cell transplant within 90 days, unless side effects have fully resolved
  • People who have had major surgery within 28 days before the trial start date
  • People who have taken certain medications that strongly affect how the body processes drugs (strong CYP3A inhibitors) within 14 days or 5 half-lives before dosing
  • People taking medications known to affect the heart's electrical rhythm (QTc-prolonging agents) within 5 half-lives before dosing
  • People who have had another cancer within the past two years
  • People with ongoing significant side effects (Grade 2 or higher) from previous cancer treatment that have not resolved, except for certain conditions considered manageable (confirm with trial site)
  • People with serious uncontrolled medical conditions
  • People with an active infection within the 14 days before the trial start date
  • People with a history or suspected diagnosis of significant lung inflammation (interstitial lung disease or pneumonitis)
  • People who are pregnant or currently breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-877-240-9479

Australian sites

Research Site, Melbourne,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
24 September 2025
Est. completion
1 March 2028

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇮🇹 Italy 🇯🇵 Japan 🇰🇷 South Korea 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of participants with dose-limiting toxicities (DLTs); Frequency, duration, severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs); Frequency of SAEs/AEs leading to discontinuation of AZD4512; Number of participants with clinically significant alterations in vitals signs and abnormal laboratory parameters

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov