Please assess the completion status of the following clinical trial:

Trial Title: Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Written informed consent signed by the patient, or parents or legal representative and assent of the minor child.~2. Age: 6 months to \< 21 years of age at time of study entry~3. Histologically confirmed low-grade glioma in non-NF1 patients (no further biopsy is needed at study entry). For patients with NF1, no biopsy is required to confirm the radiological diagnosis of the low grade glioma.~4. Relapse or refractory tumor after at least one first-line therapy, not taking into account surgery only.~5. Evaluable Disease on morphologic MRI~6. Karnofsky performance status score \>=70% for patients \>12 years of age, or Lansky score \>=70% for patients \<=12 years of age, including patients with motor paresis due to disease.~7. Life expectancy \>= 3 months.~8. Adequate organ function:~   * Adequate hematopoietic function: neutrophils ³1.0 x 109/L, platelets ³100 x 109/L; hemoglobin ³8 g/dL~  * Adequate renal function: serum creatinine \< 1.5 x ULN for age 0 - 1 year: \<= 40 µmol/L~     1 - 15 years: \<= 65 µmol/L 15 - 20 years: \<= 110 µmol/L In case serum creatinine \>1.5 ULN according to age, creatinine clearance has to be \>70 mL/min/1.73 m2 or glomerular filtration rate measurement \>70% of the expected value~  * Adequate electrolytes levels: potassium, magnesium, phosphor, total calcium Lower Limit of Normal (LLN)~  * Adequate hepatic function: total bilirubin \<=1.5 x ULN; AST and ALT \<=2.5 x ULN.~  * Absence of peripheral neuropathy \>= grade 2 (Common Toxicity Criteria Adverse Event, NCI CTCAE v4.0)~  * Adequate cardiac function:~   Shortening Fraction (SF) \>= 28% (35% for children \<3 years) and Left Ventricular Ejection Fraction (LVEF) \>= 50% at baseline, as determined by echocardiography~   Absence of QTc prolongation (QTc \> 450 msec on baseline ECG, using the QTcF formula) or other clinically significant ventricular or atrial arrhythmia~9. Wash-out period of at least~   * 3 weeks in case of preliminary chemotherapy,~  * 6 weeks in case of nitrosourea-containing chemotherapy,~  * 2 weeks in the case of treatment with vincristine only~  * 6 weeks in case of radiation therapy~10. Possibility of receiving the therapeutic schedule as indicated in the protocol~11. Patients with reproductive potential must use effective contraception during their treatment and for up to 90 days after the last dose. Females with reproductive potential must have a negative pregnancy test \<= 7 days before starting Nilotinib and/or Vinblastine.~12. Patients already treated with one of the two drugs can be enrolled in the trial provided that rechallenging them with the same drug could be considered acceptable~Exclusion Criteria:~1. Concomitant anti-tumor treatment~2. Not recovered to \<Grade 2 from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy~3. Known intolerance or hypersensitivity to Vinblastine~4. Existence of another severe systemic disease~5. Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines,~6. Any concurrent illness which in the opinion of the investigator may interfere with the treatment and evaluation of the patient~7. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of nilotinib.~8. Simultaneous treatment with strong cytochromes P450 CYP3A4 inhibitors (e.g. antiepileptic drugs, see complete list in the Appendix 5).~9. Simultaneous treatment with antiarrythmic drugs and other drugs known to prolong QT interval (cloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin, bepridil, cisapride and pimozide). A list of QT prolonging compounds can be found at http://www.azcert.org/medical-pros/druglists/drug-lists.cfm (Appendix 6)~10. Impaired cardiac function including any one of the following:~    * Clinically significant resting brachycardia (\<50 beats per minute).~   * QTc \> 450 msec on baseline ECG. If QTc \>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc.~   * Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension).~   * History of or presence of clinically significant ventricular or atrial tachyarrhythmias (including congenital long QT syndrome or a known family history of congenital long QT syndrome)

- Gender: ALL
- Minimum Age: 6 Months
- Maximum Age: 20 Years
- Healthy Volunteers: f

Study Arms:
- VINILO (Type: EXPERIMENTAL): VINILO-arm: Vinblastine and nilotinib given in combination at the RD defined in the Phase I part:~* Vinblastine: administered in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle.~* Nilotinib (Tasigna®): orally BID given continuously on Days 1- 28 Recommended doses of the drug combination will be reconsidered at an interim stage of the phase II trial after the analysis of the delayed toxicity encountered in the first 20 patients treated at the initial RD (adaptive design).
- Control Vinblastine only (Type: ACTIVE_COMPARATOR): Control Vinblastine only arm:~· Vinblastine 6 mg/m2 given in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle.~Each 28-day cycle is repeated on Day 29/Day 1.~In both treatment groups, dose reductions and/or administration delays will be performed in case of severe hematological and/or non hematological toxicities while on treatment.~Vinblastine will be temporarily stopped in case of neutropenia \<1 x109/L or thrombopenia \<75 x 109/L. It could be re-started at a reduced dose after complete recovery.~Patients benefiting from study treatment may continue up to 12 cycles as long as the toxicity-benefit ratio is adequate.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: lack of efficacy