Precursor B-Cell Lymphoblastic Leukemia-LymphomaPhase 1/2ALLPhiNCT00905398
Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
A Phase 1/2 study testing Nilotinib in people with Precursor B-Cell Lymphoblastic Leukemia-Lymphoma and Acute Lymphoblastic Leukemia, run by Rony Schaffel.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Acute Lymphoblastic Leukemia
- What is being tested?
- Nilotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jul 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Heart disease
- Interval QTc Fridericia > 480 msec
- Coumadin use
- Pregnancy
- PS = 4
- Previous medical history of etilism or/and pancreatic disease
About this study
Official title: Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada
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.
- Being tested
- Nilotinib
- Keywords
- Leukemia, Lymphoblastic, Acute, Philadelphia, BCR-ABL, Nilotinib, Treatment
- Medical subject headings
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NilotinibDrug
Also called Tasigna, AMN107
400mg, Oral, Bid, Daily for three years
| Study group | Role | What they receive |
|---|---|---|
| nilotinib | Experimental | single arm study Receives: Drug: Nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission
Measured: Day + 21 and Day + 41
Secondary outcomes (3)
Overall Survival
Measured: Three years
Molecular remission
Measured: Every three months until three years
Toxicity
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2012
- Study completionJul 2015 (estimated)
Why it stopped: The study was terminated due to excessive toxicity and low compliance to the protocol scheme.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precursor B-Cell Lymphoblastic Leukemia-LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rony Schaffel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rony Schaffel, Universidade Federal do Rio de Janeiro
- Investigators
- Rony Schaffel, MD, PHD, Principal investigator, Rio de Janeiro Federal UniversityNelson Spector, MD, PHD, Study chair, Rio de Janeiro Federal UniversityBelinda Simões, MD, PHD, Principal investigator, São Paulo University (Ribeirão Preto)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905398
- Sponsor's protocol ID
- BrALL 01-08
- Other IDs
- ANVISA, 25351732040200851
- Acronym
- ALLPhi
- Status last verified
- Jul 2015
- First submitted
- 15 May 2009
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada
- ClinicalTrials.gov ID
- NCT00905398
- Acronym / sponsor ID
- ALLPhi / BrALL 01-08
- Keywords
- Leukemia, Lymphoblastic, Acute, Philadelphia, BCR-ABL, Nilotinib, Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to excessive toxicity and low compliance to the protocol scheme.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Rony SchaffelUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2015 (estimated)
- First posted
- 20 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nilotinib | Experimental | Drug: Nilotinibsingle arm study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- Heart disease
- Interval QTc Fridericia > 480 msec
- Coumadin use
- Pregnancy
- PS = 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NilotinibAlso: Tasigna, AMN107400mg, Oral, Bid, Daily for three years | Drug | nilotinib |
Primary outcome
Complete remission
Time frame: Day + 21 and Day + 41
3 secondary outcomes
Overall Survival
Time frame: Three years
Molecular remission
Time frame: Every three months until three years
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
Results and safety
The study was stopped early (reason given: The study was terminated due to excessive toxicity and low compliance to the protocol scheme.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rony Schaffel, MD, PHD principal investigator
Rio de Janeiro Federal University
Nelson Spector, MD, PHD study chair
Rio de Janeiro Federal University
Belinda Simões, MD, PHD principal investigator
São Paulo University (Ribeirão Preto)
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nilotinib in people with Precursor B-Cell Lymphoblastic Leukemia-Lymphoma and Acute Lymphoblastic Leukemia, run by Rony Schaffel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to excessive toxicity and low compliance to the protocol scheme.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (time frame: Day + 21 and Day + 41). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.