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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.

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

PRIMAVERA Trial 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.Check my eligibility

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.See study design

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.

PRIMAVERA Trial Eligibility Criteria

Inclusion Criteria

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

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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.

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

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

PRIMAVERA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Incidence of DLTs (Dose Escalation only)

Secondary outcome measures

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

PRIMAVERA 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 / 4Eligibility criteria met

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Who is running the clinical trial?

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,612,565 Total Patients Enrolled

51 Trials studying Lymphoma

5,992 Patients Enrolled for Lymphoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what demographic is enrollment for this trial being offered?

"This medical trial is recruiting 110 participants with lymphoma aged 15 years or older and no more than 130 years old."

Answered by AI

How widely distributed is the trial taking place?

"At this time, the clinical study is accepting participants at 10 sites across the continent. These locations include Atlanta, Houston and Nedlands among other places. To reduce travel-related stressors, it would be beneficial to select a trial site as close to you as possible."

Answered by AI

Does this medical experiment accept participants who are 45 or older?

"This research initiative is open to individuals who are aged 15 or over and not older than 130."

Answered by AI

Is there still availability for patients to join this research program?

"As per the information posted on clinicaltrials.gov, this particular medical study is not actively looking for participants at present. This investigation was originally made available to public scrutiny November 24th 2023 and recently modified 11/13/2023. While recruitment of patients has temporarily ceased, 4211 other trials remain open to enrollment."

Answered by AI

What goals are researchers hoping to accomplish with this trial?

"This clinical trial will be assessed over a 28-day period, with the primary outcome of evaluation being Dose Limiting Toxicities (DLTs) for dose escalation. Secondary endpoints include Response Durations; Progression-Free Survival; and Overall Survival - all calculated from the date of first dosage or randomization."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.

2024. "AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06137144.