DR-18 to Prevent or Treat Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapse After Hemato… (NCT06492707) | Clinical Trial Compass
RecruitingPhase 1
DR-18 to Prevent or Treat Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapse After Hematopoietic Cell Transplantation, the DR. DREAM Trial
United States40 participantsStarted 2024-09-23
Plain-language summary
This phase I trial tests the safety, side effects and best dose of decoy-resistant interleukin-18 (DR-18) and how well it works in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back after a period of improvement (relapsed) or that remains despite treatment (persistent) after hematopoietic cell transplantation (HCT). HCT is the only curative therapy for most forms of AML and MDS. However, relapse occurs in a third of patients and is the most common cause of death after HCT. DR-18, a variant of the human cytokine interleukin-18, binds to IL-18 binding probein (IL-18BP) and overcomes the inhibitory effect of the IL-18BP on IL-18, which may boost the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving DR-18 may be safe, tolerable and/or effective in treating patient with relapsed or persistent AML or MDS after HCT.
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:
* ≥ 18 years of age (no upper age limit)
* The most recent HCT was from a 10/10 human leukocyte antigen (HLA)-matched related or unrelated donor (assessed at HLA-A, B, C, DR, DQ)
* Evidence of blood count recovery at any time post-HCT defined as absolute neutrophil count (ANC) ≥ 0.5 x 10\^9/L for ≥ 3 consecutive days and platelets ≥ 30 x 10\^9/L (independent of granulocyte colony-stimulating factor \[G-CSF\] or platelet transfusions for 5 days). (Blood count recovery may not be sustained.)
* Absent, stable or reducing immune suppression in the preceding 4 weeks without GvHD flares
* Karnofsky performance status (KPS) ≥ 80%
* Agrees to use a suitable method of contraception during study treatment and for 4 months after the last dose of DR-18
* Capable of providing informed consent
* GROUP 1: Documented persistent or recurrent measurable residual AML or MDS after HCT, defined as bone marrow blasts \< 5% by morphology (unless suspected to be regenerative) and malignant bone marrow blasts \< 5% by flow cytometry.
* Note: MRD (\< 5% malignant blasts) must be detected with flow cytometry testing at University of Washington Medical Center (UWMC)/Fred Hutchinson Cancer Center (Fred Hutch) clinical laboratory
* GROUP 1: Absence of circulating malignant blasts detected by the complete blood count (CBC)
* GROUP 1: Absence of extramedullary disease
* GROUP 1: Post-HCT restaging never detected overt relapse or disease persistence, defined as ≥ 5% (non-regenerative)…
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
Number of subjects who complete a minimum of 2 doses within 4 consecutive weeks of DR-18
Timeframe: At the end of week 4
2
Occurrence of dose-limiting toxicities (DLTs)
Timeframe: Up to 6 weeks after first dose of DR-18, or 2 weeks after the last induction dose of DR-18, whichever is later