Treatment for newly-diagnosed Ph+ Acute Lymphoblastic Leukemia using a chemotherapy-free regimen
An Open, Prospective, Single-arm Study of Olverembatinib Plus Venetoclax and Dexamethasone in Patients of Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia
PHASE1; PHASE2 · Xijing Hospital · NCT06082934
This study is testing a new treatment without chemotherapy for people who have just been diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia to see if it helps them achieve remission and live better.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xijing Hospital (other) |
| Drugs / interventions | Olverembatinib, chemotherapy |
| Locations | 1 site (Xi'an, Shannxi) |
| Trial ID | NCT06082934 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of a chemotherapy-free regimen consisting of Olverembatinib, venetoclax, and dexamethasone in patients with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). The primary objectives include assessing complete remission rates, measurable residual disease rates, and progression-free survival. Secondary objectives focus on evaluating the regimen's toxicities, quality of life, and overall survival. The study aims to provide a new treatment option for patients who are treatment-naïve.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of newly-diagnosed Ph+ acute lymphoblastic leukemia.
Not a fit: Patients with pre-existing conditions affecting hepatic, renal, or cardiac function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more effective option for patients with newly-diagnosed Ph+ALL.
How similar studies have performed: Other studies have shown promising results with similar chemotherapy-free approaches in treating Ph+ALL, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of newly-diagnosed Ph+ acute lymphoblastic leukemia * Age \>= 18 * Adequate hepatic function * Adequate renal function * Adequate heart function * Life expectancy of more than 3 months * Women of child-bearing potential and men with partners of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity from the time of signing the informed consent for through 120 days after the last dose of study medication. * Women of childbearing potential have negative pregnancy test within 72 hours of initiating study drug dosing. * Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study therapy through 120 days after the last dose of study therapy. * All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. * Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS program. Exclusion Criteria: * Current or anticipated use of other investigational agents. * Female patients who are lactating or have a positive serum pregnancy test during the screening period. * Major surgery within 3 weeks prior to first dose * Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose * Known or suspected HIV infection, known HIV seropositivity * Active hepatitis infection * Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal * Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance, including difficulty swallowing
Where this trial is running
Xi'an, Shannxi
- Department of Hematology, Xijing Hospital, Fourth Military Medical University — Xi'an, Shannxi, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia