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

Primary Purpose

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

Status

Terminated

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Nilotinib

About this trial

This is an interventional treatment trial for Precursor B-Cell Lymphoblastic Leukemia-Lymphoma focused on measuring Leukemia, Lymphoblastic, Acute, Philadelphia, BCR-ABL, Nilotinib, Treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nilotinib

Arm Description

single arm study

Outcomes

Primary Outcome Measures

Complete remission

Secondary Outcome Measures

Overall Survival

Molecular remission

Toxicity

Full Information

NCT ID

NCT00905398

First Posted

May 15, 2009

Last Updated

July 7, 2015

Sponsor

Rony Schaffel

1. Study Identification

Unique Protocol Identification Number

NCT00905398

Brief Title

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

Acronym

ALLPhi

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated due to excessive toxicity and low compliance to the protocol scheme.

Study Start Date

May 2009 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rony Schaffel

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

nilotinib

Arm Type

Experimental

Arm Description

single arm study

Intervention Type

Drug

Intervention Name(s)

Nilotinib

Other Intervention Name(s)

Tasigna, AMN107

Intervention Description

400mg, Oral, Bid, Daily for three years

Primary Outcome Measure Information:

Title

Complete remission

Time Frame

Day + 21 and Day + 41

Secondary Outcome Measure Information:

Title

Overall Survival

Time Frame

Three years

Title

Molecular remission

Time Frame

Every three months until three years

Title

Toxicity

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rony Schaffel, MD, PHD

Organizational Affiliation

Rio de Janeiro Federal University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nelson Spector, MD, PHD

Organizational Affiliation

Rio de Janeiro Federal University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Belinda Simões, MD, PHD

Organizational Affiliation

São Paulo University (Ribeirão Preto)

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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