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New treatment option for Acute Lymphoblastic Leukaemia
Official title Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression
ClinicalTrials.gov ID: NCT07155226
What this study is testing
What is AZD3632?
AZD3632 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute lymphoblastic leukaemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Key Core criteria:
- Adequate organ function.
- Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for...
- Advanced haematologic malignancy - a) for dose escalation - diagnosis of acute leukemia or myelodysplastic neoplasia (MDS) and harbouring one of the...
- Participants must have measurable disease that is relapsed/refractory to conventional therapies known to be effective for their disease and not have...
You likely can't join if
- Core criteria:
- Participants with Burkitt lymphoma/leukaemia or Acute Promyelocytic Leukaemia.
- Active testicular or active central nervous system (CNS) (\> CNS1 or radiographic) involvement by leukaemia.
- Unresolved treatment-related toxicities Grade ≥ 2 from prior therapy.
- Abnormal levels of potassium or magnesium prior to first dose of AZD3632. Module 1:
- Receipt of non-CNS radiation therapy within 2 weeks and of CNS radiation within 8 weeks of the first scheduled dose.
See the full eligibility criteria
- Key Core criteria:
- Adequate organ function.
- Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Module 1:
- Advanced haematologic malignancy - a) for dose escalation - diagnosis of acute leukemia or myelodysplastic neoplasia (MDS) and harbouring one of the genetic alterations per local testing associated with upregulation of...
- Participants must have measurable disease that is relapsed/refractory to conventional therapies known to be effective for their disease and not have any available approved therapies.: a) Relapsed and primary refractory...
- Participants must have measurable disease that is relapsed/refractory to conventional therapies known to be effective for their disease and not have any available approved therapies.: a) Relapsed and primary refractory...
- Core criteria:
- Participants with Burkitt lymphoma/leukaemia or Acute Promyelocytic Leukaemia.
- Active testicular or active central nervous system (CNS) (\> CNS1 or radiographic) involvement by leukaemia.
- Unresolved treatment-related toxicities Grade ≥ 2 from prior therapy.
- Abnormal levels of potassium or magnesium prior to first dose of AZD3632. Module 1:
- Receipt of non-CNS radiation therapy within 2 weeks and of CNS radiation within 8 weeks of the first scheduled dose.
- Receipt of any investigational or non-investigational anticancer agents, including non-biologic agents, biologic agents and/or prior treatment other menin inhibitors (backfill participants only).
- For nested food effect participants - diagnosis of diabetes mellitus (Type I or Type II). Module 2:
- Receipt of any non-investigational anticancer agents, including non-biologic agents and/or biologic agents or receipt of non-CNS or CNS radiation therapy.
- Participants for whom treatment with posaconazole is contraindicated per the local prescribing information.
The study team makes the final eligibility decision.
Where it's taking place
- Decatur, Illinois, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Fitzroy, Australia
- Perth, Australia
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Copenhagen, Denmark
- Dresden, Germany
- Frankfurt A. Main, Germany
- Halle, Germany
- Heidelberg, Germany
- München, Germany
- Ulm, Germany
- Bologna, Italy
- Ravenna, Italy
- Bunkyō City, Japan
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Decatur, Illinois, United States; New York, New York, United States; Chapel Hill, North Carolina, United States; Durham, North Carolina, United States; Portland, Oregon, United States; Houston, Texas, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.