Clinical trial · Interventional
Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to excessive toxicity and low compliance to the protocol scheme.
Summary
Brief summary (as posted)
Patients with acute lymphoblastic leukemia and positivity for the breakpoint cluster region-Abelson murine leukemia (BCR-ABL) protein or the Philadelphia chromosome have a poor prognosis with standard chemotherapy. The prognosis seemed to improve following the adition of imatinibe, a BCR-ABL inhibitor, to the treatment but still a substantial amount of patients relapse or progress during treatment. Nilotinib is a BCR-ABL inhibitor more potent than imatinib. It has been shown to be effective against most of the cells that bear mutations of the BCR-ABL protein leading to resistance to imatinibe. The investigators' hypothesis is that the addition of nilotinib to a standard chemotherapy for acute lymphoblastic leukemia (ALL) will translate into more rapid BCR-ABL reduction and effectiveness against imatinib-resistant clones leading to less relapses and better survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Precursor B-Cell Lymphoblastic Leukemia-Lymphoma | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nilotinib | Drug | Nilotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nilotinib
- description
- single arm study
- interventionNames
- Drug: Nilotinib
Primary outcomes (1)
- measure
- Complete remission
- timeFrame
- Day + 21 and Day + 41
Secondary outcomes (3)
- measure
- Overall Survival
- timeFrame
- Three years
- measure
- Molecular remission
- timeFrame
- Every three months until three years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Acute Lymphoblastic Leukemia (ALL) * BCR-ABL positive positive by PCR (central Lab) * No previous treatment for ALL except for corticoids and cyclophosphamide less than 600 mg/m2 * Must be able to swallow tablets * Lab results within normal limits (Potassium, Calcium, Magnesio, Phosphorus, Transaminases, Alkaline Phosphatase, Bilirrubine, Amylase, Lypase) Exclusion Criteria: * Heart disease * Interval QTc Fridericia \> 480 msec * Coumadin use * Pregnancy * PS = 4 * Previous medical history of etilism or/and pancreatic disease
References
Publications (0)
Data not yet available