NCT05127148Recruiting
RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL
Real-world Evidence of First-line Treatment With Pediatric-like Protocol for Adolescents and Young Adults Patients Diagnosed With Philadelphia-negative Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 9 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 9 Nov 2021
- Start date
- 1 Mar 2021
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Grupo Argentino de Tratamiento de la Leucemia Aguda
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT05127148
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Mar 2021 to the primary completion date, 1 Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with a history of coronary, valvular or hypertensive heart disease, that contraindicate the use of anthracyclines.
- 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.
Lab values
- 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.
Other
- 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).
- 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.
Who the study is looking for
- Signature of the form consent for participation in the study
- Ph-negative ALL diagnosis without previous treatment.
Age in the registry: 18 years to 40 years · Sex: All
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| FUNDALEU Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| Instituto Privado de Hematologia y Hemoterapia Coordinator of this site? Confirm its status | Paraná | Argentina | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.