DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NCT05824585) | Clinical Trial Compass
CompletedPhase 1
DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
United States, Australia17 participantsStarted 2023-05-15
Plain-language summary
This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female participants who have provided ICF with age ≥ 18 yrs
. ECOG performance 0-2, no deterioration in the past 2 weeks
. Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma
. Adequate bone marrow reserve and organ system functions
. Participants willing to comply with contraceptive restrictions
Exclusion criteria
. Any unresolved \> Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A: Incidence of adverse events
Timeframe: 30 days after the last dose, assessed up to 2 years
2
Part B: Objective Response Rate assessed by investigators
. Prior history of allogeneic hematopoietic stem cell transplantation
. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks
. Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months
. Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.
. CNSL participants with systemic presence of lymphoma, unable to complete lumbar puncture, under systemic corticosteroids at a dose \> 8 mg/day (dexamethasone equivalent dose) within 14 days or requiring immunosuppressive or biologic therapy."
. Participants with infectious disease:
. Clinically significant cardiac disorders or abnormalities