180 Participants Needed

AZD0486 for Lymphoma

(Soundtrack-E Trial)

Recruiting at 44 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the safety and efficacy of AZD0486 administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies.

Will I have to stop taking my current medications?

The trial requires that you stop any anticancer therapy at least 21 days before starting the study drug. If you are taking a CYP3A inhibitor or inducer, you may need to stop, especially for certain cohorts. The protocol does not specify other medications, so it's best to discuss with the trial team.

Are You a Good Fit for This Trial?

This trial is for adults with certain types of blood cancers, like lymphoma and leukemia. They should be able to perform daily activities (ECOG 0-2) and use contraception. Specific groups need different prior treatments: one must have had at least two therapies including BTKi and BCL2i; another can join if sensitive to BTKi after one therapy.

Inclusion Criteria

I can care for myself and am up and about more than 50% of my waking hours.
I will use birth control during and for 6 months after treatment.
My lymphocyte count is below 10,000.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive AZD0486 as monotherapy or in combination with other anticancer agents

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 years 4 months

What Are the Treatments Tested in This Trial?

Interventions

  • AZD0486
Trial Overview The study tests AZD0486 alone or with other cancer drugs (Vincristine, Doxorubicin, Prednisone, Cyclophosphamide, Acalabrutinib, Rituximab) in patients with mature B-cell malignancies. It aims to find out how safe and effective these combinations are against the disease.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Substudy 3 (LBCL): AZD0486 + R-CHOPExperimental Treatment6 Interventions
Group II: Substudy 2 (RR MCL): Cohort 2B (AZD0486 + Acalabrutinib)Experimental Treatment2 Interventions
Group III: Substudy 2 (RR MCL): Cohort 2A (AZD0486 Monotherapy)Experimental Treatment1 Intervention
Group IV: Substudy 1 (RR CLL/SLL): Cohort 1B (AZD0486 + Acalabrutinib)Experimental Treatment2 Interventions
Group V: Substudy 1 (RR CLL/SLL): Cohort 1A (AZD0486 Monotherapy)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

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