Non-intensive treatment for adults with Ph-negative acute lymphoblastic leukemia
Official title: Multicenter Prospective Study of Safety and Efficacy MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
Run by National Research Center for Hematology, Russia · NCT06237192 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | National Research Center for Hematology, Russia Research network |
| Drugs / interventions | blinatumomab, methotrexate, chemotherapy |
| Locations | 1 site (Moscow) |
| Status | Recruiting |
| Started | April 1, 2023 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2027 |
| Registry record updated | February 1, 2024 |
| Trial ID | NCT06237192 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-55 years with a clinical diagnosis of untreated Ph-negative acute lymphoblastic leukemia.
✕Probably not a fit
Patients over 55 years old or those with Ph-positive or relapsed/refractory ALL may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is based on previous studies, the specific non-intensive treatment strategy being tested is novel and has not been widely implemented.
Who can join: the full rules
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 it's running
-
Olga Aleshina
Moscow, Russia Recruiting
Study contacts
- Study coordinator: Olga Aleshina, MD, PhD
- Email: dr.gavrilina@mail.ru
- Phone: +79629745058
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.