Actively Recruiting
Multicenter Prospective Study of Safety and Efficacy MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
Led by National Research Center for Hematology, Russia · Updated on 2024-02-01
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial studies adult patients aged 18 to 55 with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph-negative ALL). It evaluates a non-intensive but continuous treatment approach based on previous research (RALL-2016), focusing on minimizing high-dose chemotherapy while targeting minimal residual disease (MRD) status to guide therapy. Specialized therapies are given to patients with persistent MRD after initial treatment phases to improve disease-free survival. The treatment includes a 7-day prednisolone prephase followed by 8 weeks of induction chemotherapy with reduced intensity. For patients reaching complete remission but still MRD-positive, T-cell ALL patients receive consolidation therapy with venetoclax for 56 days, and B-cell ALL patients receive one consolidation with blinatumomab. Therapy continues with five consolidation phases and two years of maintenance, including 21 intrathecal injections throughout. MRD is closely monitored at specified intervals, and allogeneic stem cell transplant is reserved for very high-risk patients. Participants undergo regular assessments including MRD testing using flow cytometry at multiple time points, bone marrow sample collection after consolidation, and safety monitoring. Researchers measure disease-free survival over three years as the primary outcome, with MRD-negativity and overall survival as secondary outcomes. The study duration includes treatment and follow-up, emphasizing continuous therapy without interruption based on MRD results.
CONDITIONS
Brief Title
MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 55 years old
- Clinical diagnosis of untreated Philadelphia chromosome-negative acute lymphoblastic leukemia
You will not qualify if you...
- Age over 55 years old
- Clinical diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia
- Clinical diagnosis of relapsed or refractory acute lymphoblastic leukemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive a 7-day prednisolone prephase before starting induction therapy.
1 visit (in-person)
Duration - Approximately 2 years and 8 weeks
Participants undergo induction therapy for 8 weeks with de-escalated chemotherapy followed by up to 5 consolidation phases and 2 years of maintenance treatment. MRD-positive patients receive targeted therapies with blinatumomab for B-ALL or venetoclax for T-ALL as part of consolidation.
Multiple visits throughout induction, consolidation, and maintenance phases
Duration - Up to 3 years
Participants are monitored with centralized MRD assessments at specific time points and observed for disease-free and overall survival outcomes.
Assessments at +70 days, +133 days, +190 days, and before and after allo-HSCT if applicable
Trial Site Locations
Total: 1 location
1
Olga Aleshina
Moscow, Russia
Actively Recruiting
Research Team
O
Olga Aleshina, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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