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

NCT00905398 | Terminated Phase 1 DMC

• 3 other identifiers: BrALL 01-08ANVISA25351732040200851
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Complete remission

  Day + 21 and Day + 41

Secondary Outcomes (3)

• 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

Study Arms (1)

nilotinib

EXPERIMENTAL

single arm study

Drug: Nilotinib

Interventions

Nilotinib DRUG

400mg, Oral, Bid, Daily for three years

Also known as: Tasigna, AMN107

nilotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Heart disease
• Interval QTc Fridericia \> 480 msec
• Coumadin use
• Pregnancy
• PS = 4
• Previous medical history of etilism or/and pancreatic disease

Sponsors & Collaborators

• Rony Schaffel: lead

MeSH Terms

Conditions

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rony Schaffel, MD, PHD

  Rio de Janeiro Federal University

  PRINCIPAL INVESTIGATOR

• Nelson Spector, MD, PHD

  Rio de Janeiro Federal University

  STUDY CHAIR

• Belinda Simões, MD, PHD

  São Paulo University (Ribeirão Preto)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 20, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2015
• Last Updated: July 9, 2015

Record last verified: 2015-07