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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00905398

Acronym

ALLPhi

Enrollment

Registered

2009-05-20

Start date

2009-05-31

Completion date

2015-07-31

Last updated

2015-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Keywords

Leukemia, Lymphoblastic, Acute, Philadelphia, BCR-ABL, Nilotinib, Treatment

Brief summary

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.

Interventions

DRUGNilotinib

400mg, Oral, Bid, Daily for three years

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Complete remission	Day + 21 and Day + 41

Secondary

Measure	Time frame
Overall Survival	Three years
Molecular remission	Every three months until three years
Toxicity	Three times a week for the first 40 days than once weekly for the next 9 months than monthly for the next 2.1 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026