Real-world Evidence of First-line Treatment With Pediatric-like Protocol for Adolescents and Young Adults Patients Diagnosed With Philadelphia-negative Acute Lymphoblastic Leukemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Evaluate overall survival of AYA Ph-negative ALL patients treating in first line depending on risk category.
Study Overview
Brief Summary
This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of adolescent and young patients with ph-negative acute lymphoblastic leukemia with first-line pediatric-like protocol in Argentina.
Detailed Description
The purpose of this trial is to gather real world evidence of treatment outcomes and toxicities of AYA Ph-negative ALL patients in Argentina who receive pediatric-like treatment in first line.
The study primary endpoints are to evaluate survival (event free survival and overall survival) and toxicities of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Secondary endpoints are to evaluate survival in patients who underwent allogeneic transplantation in first remission, asparaginase toxicities, and assess central cerebrospinal fluid by flow cytometry.
Every ALL patient diagnosed in our institutions will follow our guidelines with respect to diagnosis procedures.
High-risk (HR) group was defined as presenting high risk cytogenetics/molecular findings and depending on the response achieved at different time points: bad response to prednisone at day 8, ≥ 10% blast in bone marrow on day 15, minimal residual disease (MRD) by flow cytometry ≥0.1% at day 33 and ≥0.01% at day 78 in bone marrow. No-high risk group was defined as those without any high-risk factor.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signature of the form consent for participation in the study
- •Ph-negative ALL diagnosis without previous treatment.
Exclusion Criteria
- •ALL with mature B phenotype (sIg +) or with the cytogenetic alterations characteristic of ALL mature B (t (8,14), t (2, 8), t (8, 22)).
- •Ph-positive ALL
- •Acute leukemias of ambiguous lineage (undifferentiated or mixed phenotype).
- •Patients with a history of coronary, valvular or hypertensive heart disease, that contraindicate the use of anthracyclines.
- •Patients with chronic liver disease in the activity phase and / or Bilirubin> 2 mg / dl and / or transaminases 5 times the normal limit, not related to ALL.
- •Patients with severe chronic respiratory failure.
- •Renal failure and / or creatininemia> 2 mg / dl not related to ALL.
- •Serious neurological disorders, not related to leukemic disease.
- •General condition affected (grades 3 and 4), not attributable to ALL.
- •Uncontrolled infection by HIV, HTLV-1, HBV, HCV.
- •Patient not a candidate for treatment based on the criteria of the treating physician.
- •Pregnant women will have to be evaluated by a multidisciplinary team and an ethics committee.
Outcomes
Primary Outcomes
Evaluate overall survival of AYA Ph-negative ALL patients treating in first line depending on risk category.
Time Frame: 36 months
Evaluate overall survival of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Evaluate event free survival of AYA Ph-negative ALL patients treating in first line depending on risk category.
Time Frame: 36 months
Evaluate event free survival of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Evaluate toxicities of AYA Ph-negative ALL patients treating in first line depending on risk category.
Time Frame: 36 months
Evaluate toxicities of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Secondary Outcomes
- Evaluate asparaginase toxicities.(36 months)
- Assess central cerebrospinal fluid involvement by flow cytometry.(36 months)
- Evaluate survival in patients who underwent allogeneic transplantation in first remission(36 months)