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LeukemiaPhase 2NCT00844298

Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

A Phase 2 study testing Nilotinib+mVPD in people with Leukemia, run by Asan Medical Center at 16 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Leukemia
What is being tested?
Nilotinib+mVPD
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
16 sitesSouth Korea
Study dates
Jan 2009to Jul 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute lymphoblastic leukemia or acute mixed lineage leukemia
  • Positive for Bcr-Abl fusion transcript (Philadelphia chromosome-positive disease) by RT-PCR

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Total bilirubin < 2 mg/dL
  • SGOT < 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN (unless considered tumor-related)
  • Creatinine < 2.0 mg/dL ULN
  • Serum amylase and lipase ≤ 1.5 times ULN
  • Potassium, magnesium, and phosphorus normal (supplementation allowed)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No rare hereditary problems with galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption
  • No known sensitivity to any of the study drugs
  • No severe medical condition that, in the opinion of the investigator, would preclude study participation
  • No impaired cardiac function, including any of the following:
  • LVEF < 45% or below the lower limit of normal by ECHO
  • Long QT syndrome or known family history of long QT syndrome
  • Clinically significant resting bradycardia (< 50 beats per minute)
  • QTc > 450 msec on baseline ECG (using the QTcF formula)
  • Myocardial infarction within the past 12 months
  • Other clinically significant heart disease, including any of the following:
  • Unstable angina
  • Congestive heart failure
  • Uncontrolled hypertension
  • Uncontrolled arrhythmias
  • No other primary malignant disease requiring systemic treatment
  • No acute or chronic liver, pancreatic, or severe renal disease
  • No other severe and/or life-threatening medical disease
  • No history of significant congenital or acquired bleeding disorder unrelated to cancer
  • No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug
  • No history of non-compliance

PRIOR CONCURRENT THERAPY:

  • More than 30 days since prior investigational agents
  • No concurrent medications that have the potential to prolong the QTc interval
  • No concurrent strong CYP3A4 inhibitors
  • No concurrent therapeutic coumarin derivatives

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

South Korea16 sites

  • Daegu Fatima Hospital

    Daegu, 701-600

  • Kyungpook National University Hospital

    Daegu, 702-701

  • Yeungnam University Medical Center

    Daegu, 712-749

  • Daegu Catholic University Hospital

    Daegu

  • National Cancer Center - Korea

    Goyang, 410-769

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 519-809

  • Gyeongsang National University Hospital

    Jinju, 660-701

  • Pusan National University Hospital

    Pusan, 602-739

  • Inje University Seoul Paik Hospital

    Seoul, 100-032

  • Seoul National University Hospital

    Seoul, 110-744

  • Kyung Hee University Hospital

    Seoul, 130-702

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center - University of Ulsan College of Medicine

    Seoul, 138-736

  • Konkuk University Medical Center

    Seoul, 143-729

  • Ajou University Hospital

    Suwon, 441-749

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

About this study

Official title: Tasigna® (Nilotinib) Plus Multi-Agent Chemotherapy for Newly-Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving nilotinib together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving nilotinib together with combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the clinical efficacy of nilotinib and combination chemotherapy, in terms of hematologic and molecular complete remission (CR) rates, in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia or acute mixed lineage leukemia.

Secondary

  • To establish the prognostic factors for patients treated with this regimen.
  • To determine the duration of CR in patients treated with this regimen.
  • To determine the duration of progression-free and overall survival of these patients.
  • To determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to age (15 to 64 years vs ≥ 65 years).

  • Induction therapy: Patients receive daunorubicin hydrochloride IV continuously over 24 hours on days 1-3, vincristine sulfate IV on days 1 and 8, and oral prednisolone on days 1-14. Patients undergo bone marrow examination on day 14. Patients in hematologic remission proceed to consolidation therapy. Patients with residual leukemic cells > 5% receive an additional dose of daunorubicin hydrochloride IV continuously over 24 hours on day 15 before proceeding to consolidation therapy.
  • Consolidation therapy: For course 1, patients receive daunorubicin hydrochloride IV continuously over 24 hours on days 1 and 2, vincristine sulfate IV on days 1 and 8, and oral prednisolone on days 1-14. For courses 2 and 4, patients receive cytarabine IV over 2 hours and etoposide IV over 3 hours on days 1-4. For courses 3 and 5, patients receive methotrexate IV continuously over 36 hours on days 1, 2, 15, and 16 and leucovorin calcium IV every 6 hours for 3 doses and then orally until blood methotrexate levels are in a safe range.

Patients also receive oral nilotinib twice daily beginning on day 8 of induction therapy and continuing until the completion of consolidation therapy.

After completion of consolidation therapy, patients with a hematopoietic stem cell donor proceed to allogeneic hematopoietic stem cell transplantation (HSCT). Patients who do not undergo HSCT continue to receive oral nilotinib twice daily for up to 2 years after completion of consolidation therapy.

After completion of study therapy, patients are followed periodically for up to 1 year.

Conditions
Leukemia
Being tested
Nilotinib+mVPD
Keywords
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia
Medical subject headings
Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nilotinib+mVPDDrug

    Also called Mabthera, VCS, Daunobrastina, Solondo

    1. Induction:
    • Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)
    • Vincristine 2 mg iv push (d1, 8, 15, 22)
    • Prednisolone 60 mg/m2/day po (d1-28)
    • Nilotinib 400mg bid/d (d8-)
    1. Consolidation A (cycle1)
    • Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)
    • Vincristine 2 mg iv (d1, 8)
    • Prednisolone 60 mg/m2/day po (d1-14)
    • Nilotinib 400mg bid/d
    1. Consolidation B (cycles 2\&4)
    • Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)
    • Etoposide 150 mg/m2/day iv over 3 hours (d1-4)
    • Nilotinib 400mg bid/d
    1. Consolidation C (cycles 3\&5)
    • Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)
    • Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,
    • Nilotinib 400mg bid/d
    1. Maintenance ◦Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)
    2. Consider alloHCT
Study groups in NCT00844298
Study groupRoleWhat they receive
Nilotinib+mVPDExperimentalPatients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan
Receives: Drug: Nilotinib+mVPD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy

    approximate time: at the recovery of cytopenia

    Measured: 1 month

Secondary outcomes (2)

  1. Disease(Relapse)-Free Survival

    Measured: 2 years

  2. Overall Survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionJun 2012
  4. Study completionJul 2014

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00844298
Sponsor's protocol ID
CDR0000632225
Other IDs
AMC-UUCM-2008-0310, NOVARTIS-AMC-UUCM-2008-0310
Status last verified
Aug 2015
First submitted
13 Feb 2009
Last updated
7 Sep 2015
Data monitoring committee
No

Publications

  • Kim DY, Joo YD, Lim SN, Kim SD, Lee JH, Lee JH, Kim DH, Kim K, Jung CW, Kim I, Yoon SS, Park S, Ahn JS, Yang DH, Lee JJ, Lee HS, Kim YS, Mun YC, Kim H, Park JH, Moon JH, Sohn SK, Lee SM, Lee WS, Kim KH, Won JH, Hyun MS, Park J, Lee JH, Shin HJ, Chung JS, Lee H, Eom HS, Lee GW, Cho YU, Jang S, Park CJ, Chi HS, Lee KH; Adult Acute Lymphoblastic Leukemia Working Party of the Korean Society of Hematology. Nilotinib combined with multiagent chemotherapy for newly diagnosed Philadelphia-positive acute lymphoblastic leukemia. Blood. 2015 Aug 6;126(6):746-56. doi: 10.1182/blood-2015-03-636548. Epub 2015 Jun 11.

    PubMed 26065651

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nilotinib+mVPD in people with Leukemia, run by Asan Medical Center at 16 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

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?

Yes. Results are posted in the registry (first posted 7 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00844298, which also lists 1 linked publication.

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 7 Sep 2015.

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