Clin2
NCT05445154Possibly a fitRecruiting

New treatment for newly diagnosed FLT3 AML with oral drugs

Newly Diagnosed Acute Myeloid Leukemia (AML)

Part of Blood & lymphatic, Cancer clinical trials.

This Phase 1/2 study tests SKLB1028 (with daunorubicin and cytarabine) in people with newly diagnosed acute myeloid leukemia (AML) who have an FLT3 mutation. It aims to see how well and how safely this treatment works for this specific type of AML.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1/Phase 2
Enrollment
58 people
Ages
18 years to 59 years
Study type
Interventional

Who can take part

  • You have newly diagnosed de novo AML (not from prior cancer treatment), with more than 20% leukemia cells in the bone marrow
  • You are age 18 to under 60
  • Your leukemia test shows an FLT3 mutation on a central lab test
  • You are well enough to function day-to-day (ECOG score 0 to 2)
  • Your blood and organ lab tests are acceptable (bilirubin and kidney function limits must be met)
  • Your doctor says you can safely take the study drug by mouth

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

Similar studies

Other trials that look related to this one.

NCT05886049Recruiting· Phase 1
Testing a menin drug with standard chemo for newly diagnosed AML

This early-phase study tests a menin inhibitor drug (SNDX-5613) combined with standard induction chemotherapy (daunorubicin plus cytarabine) in newly diagnosed AML with specific gene changes (NPM1 or FLT3 status, or MLL/KMT2A or NUP98). It may help patients whose AML has these genetic features respond better to intensive treatment.

Orange, California
NCT04140487Recruiting· Phase 1/Phase 2
Study drugs for certain FLT3-mutated blood cancers that have returned

This trial tests a combination of three medicines—azacitidine, venetoclax, and gilteritinib—in people with specific gene changes (FLT3 mutations) in leukemia and related bone marrow diseases that have come back or are hard to treat. The goal is to see if this drug combination can control the disease and improve outcomes.

Houston, Texas
NCT07255872Not yet recruiting· Phase 2/Phase 3
BL-M11D1 plus chemo for newly diagnosed AML

This study tests a new drug called BL-M11D1 combined with standard chemotherapy (cytarabine + daunorubicin) or a targeted therapy (venetoclax + azacitidine) for people with newly diagnosed acute myeloid leukemia (AML). It aims to see if this combination is safe and effective.

Tianjin, Tianjin Municipality
NCT05554406Recruiting· Phase 2
New drug therapy for high-risk AML

This trial is testing new drug combinations for people with newly diagnosed, high-risk AML who have not yet started treatment. It aims to find more effective therapies for this aggressive form of leukemia.

Birmingham, Alabama
NCT07549464Not yet recruiting· Phase 1
Testing PLM-102 for Hard-to-Treat Blood Cancer

This trial tests a new drug called PLM-102 in adults whose acute myeloid leukemia (a serious blood cancer) has come back or stopped responding to standard treatment. The goal is to see if PLM-102 can help patients whose cancer has proven difficult to control.

Houston, Texas
NCT07751991Recruiting· Phase 1
Study of a new drug for relapsed AML with specific genetic changes

This trial tests a new drug for people with acute myeloid leukemia (AML) that has come back or hasn't responded to standard therapies, and whose leukemia has certain genetic markers. The drug may target these specific changes to help stop the cancer.

Grand Rapids, Michigan

Hear when a new Newly Diagnosed Acute Myeloid Leukemia (AML) trial opens

We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.