Non-intensive treatment for adults with Ph-negative acute lymphoblastic leukemia
Multicenter Prospective Study of Safety and Efficacy MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
This study is testing a gentler treatment for adults with Ph-negative acute lymphoblastic leukemia who are in remission but still have some cancer cells, to see if it can help them avoid more intense treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | National Research Center for Hematology, Russia Research network |
| Drugs / interventions | blinatumomab, methotrexate, chemotherapy |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06237192 on ClinicalTrials.gov |
What this trial studies
This study evaluates a non-intensive treatment approach for adult patients with Ph-negative acute lymphoblastic leukemia (ALL) who are in complete remission but have minimal residual disease (MRD). The treatment involves a combination of venetoclax for T-cell ALL and blinatumomab for B-cell ALL, along with a structured regimen of intrathecal injections and maintenance therapy. The study aims to monitor MRD status closely and adjust treatment based on patient response, potentially avoiding more aggressive interventions like hematopoietic stem cell transplantation for certain patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-55 years with a clinical diagnosis of untreated Ph-negative acute lymphoblastic leukemia.
Not a fit: Patients over 55 years old or those with Ph-positive or relapsed/refractory ALL may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less intensive yet effective option for managing Ph-negative ALL, improving patient quality of life and outcomes.
How similar studies have performed: While this approach is based on previous studies, the specific non-intensive treatment strategy being tested is novel and has not been widely implemented.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • age 18-55 years old of patient, \- Clinical diagnosis of non-treated Ph-negative ALL Exclusion Criteria: • age more than 55 years old, * Clinical diagnosis of Ph-positive ALL * Clinical diagnosis of relapsed/refractory ALL,
Where this trial is running
Moscow
- Olga Aleshina — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Olga Aleshina, MD, PhD
- Email: dr.gavrilina@mail.ru
- Phone: +79629745058
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.