Clinical trial · Interventional
Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Tasigna® (Nilotinib) Plus Multi-Agent Chemotherapy for Newly-Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nilotinib+mVPD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nilotinib+mVPD
- description
- Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan
- interventionNames
- Drug: Nilotinib+mVPD
Primary outcomes (1)
- measure
- Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy
- timeFrame
- 1 month
- description
- approximate time: at the recovery of cytopenia
Secondary outcomes (2)
- measure
- Disease(Relapse)-Free Survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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 derivativesReferences
Publications (1)
- DERIVEDKim 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. PMID 26065651