Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

— ALLPhi  

Official title:

Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00905398
• Other study ID #: BrALL 01-08
• Secondary ID: ANVISA2535173204
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: May 15, 2009
• Last updated: July 7, 2015
• Start date: May 2009
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 2015
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Philadelphia Chromosome
• Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Nilotinib
400mg, Oral, Bid, Daily for three years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rony Schaffel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission		Day + 21 and Day + 41	Yes
Secondary	Overall Survival		Three years	Yes
Secondary	Molecular remission		Every three months until three years	No
Secondary	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	Yes