Recruiting at 135 sites Phase 3 Chronic Myeloid Leukemia

Chronic Myeloid Leukemia study: Olverembatinib vs Bosutinib

Official title Study of Olverembatinib (HQP1351) in Patients With CML-CP

ClinicalTrials.gov ID: NCT06423911

What this study is testing

What is olverembatinib?

This is an investigational medicine being studied as a potential treatment for chronic myeloid leukemia. is designed to block specific proteins that help leukemia cells grow and divide.

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
This study aims to see if olverembatinib works as well as or better than the current drug bosutinib. It also checks if olverembatinib is safe for people with a specific genetic change.
Who it's for
People who have chronic myeloid leukemia in its early, stable stage.
What's involved
Participants will take either the new drug or the standard drug. They will have regular check-ups and blood tests to monitor how the treatment is working.
Time commitment
The study involves ongoing visits and tests for the duration of the treatment period.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age ≥ 18 years old
  • Diagnosis of CML-CP
  • Part A: Previously treated with at least two approved TKIs; Part B: T315I mutation at screening and previously treated with at least one approved...
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  • Patient has adequate organ function

You likely can't join if

  • For Part A only: T315I or V299L mutation at any time prior to starting study treatment
  • Active infection that requires systemic drug therapy
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
  • Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients
  • Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients
  • Pregnant or nursing (lactating) women

The study team makes the final eligibility decision.

Where it is enrolling

  • Birmingham, Alabama, United States
  • Anchorage, Alaska, United States
  • Goodyear, Arizona, United States
  • Duarte, California, United States
  • Irvine, California, United States
  • La Jolla, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • Upland, California, United States
  • Augusta, Georgia, United States
  • Newnan, Georgia, United States
  • Chicago, Illinois, United States
  • Decatur, Illinois, United States
  • Indianapolis, Indiana, United States
  • Wichita, Kansas, United States
  • Lexington, Kentucky, United States
  • Louisville, Kentucky, United States
  • Baltimore, Maryland, United States
  • Detroit, Michigan, United States

+ 96 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, but 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, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Birmingham, Alabama, United States; Anchorage, Alaska, United States; Goodyear, Arizona, United States; Duarte, California, United States; Irvine, California, United States; La Jolla, California, United States and 110 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.