← Back to Search

Other

AZD3470 for Blood Cancer (PRIMAVERA Trial)

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have documented r/r active disease, must have previously received at least 3 prior lines of therapy for the treatment of cHL, and must have exhausted all available therapies with demonstrated clinical benefit.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Must not have

Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord compression.

Severe valvular heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of azd3470 to end of cycle 1 (each cycle is 21 days).

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates the safety & effectiveness of a new drug for blood cancer treatments.

Who is the study for?

This trial is for adults with relapsed/refractory Hodgkin's or Non-Hodgkin's Lymphoma who've tried at least three treatments without success. They must have a measurable lymphoma lesion, good organ and bone marrow function, and be willing to use contraception. Excluded are those with severe medical conditions, active CNS lymphoma involvement, certain heart issues, uncontrolled infections like HIV/HBV/HCV, or prior treatment with MAT2A/PRMT5 inhibitors.

What is being tested?

The study tests AZD3470 alone and combined with other cancer drugs in patients with blood cancers. It aims to assess the safety and initial effectiveness of oral AZD3470 doses. The trial has two parts: dose escalation (Part A) to find a safe dosage level and dose optimization/expansion (Part B) to further evaluate that dosage.

What are the potential side effects?

While specific side effects of AZD3470 aren't listed here, common ones for anticancer agents may include nausea, fatigue, risk of infection due to low blood cell counts, liver problems, diarrhea or constipation. Side effects can vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have relapsed or refractory Hodgkin lymphoma and have tried at least 3 treatments.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

I have a lymphoma lesion larger than 1.5 cm that can be seen on scans.

Select...

My Hodgkin's lymphoma diagnosis is confirmed and resistant to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My lymphoma has spread to my brain or spinal cord.

Select...

I have severe heart valve disease.

Select...

I have had or currently have a heart muscle problem.

Select...

My high blood pressure is not under control.

Select...

I have had a stroke or mini-stroke.

Select...

I have had another type of cancer in the past.

Select...

I have been treated with a MAT2A or PRMT5 inhibitor before.

Select...

I do not have stomach or bowel problems affecting my medication intake.

Select...

My heart condition is between moderate to severe.

Select...

I don't have lasting side effects from cancer treatment, except for hair loss.

Select...

I am currently on medication to suppress my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of azd3470 to end of cycle 1 (each cycle is 21 days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of azd3470 to end of cycle 1 (each cycle is 21 days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of azd3470 to end of cycle 1 (each cycle is 21 days). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Incidence of DLTs (Dose Escalation only)

Secondary study objectives

Part A and Part B: Area under the plasma concentration-curve over the dosing interval (AUCtau)

Part A and Part B: Maximum observed plasma drug concentration (Cmax)

Part A and Part B: Minimum observed plasma drug concentration (Cmin)

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Module 1: Part A (Dose Escalation) and Part B (Dose Expansion/Optimization)Experimental Treatment1 Intervention

In Part A, participants with Relapsed/Refractory classical Hodgkin Lymphoma (cHL) will take AZD3470 tablets orally until PD, unacceptable toxicity, or withdrawal of consent. In Part B, adult and adolescent participants with r/r cHL will take AZD3470 tablets orally until PD, unacceptable toxicity, or withdrawal of consent.

0 / 15Eligibility criteria met