Please assess the completion status of the following clinical trial:

Trial Title: Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Cytogenetically proven Down Syndrome (constitutional trisomy 21) with transient myeloproliferative disorder (TMD), myelodysplastic syndromes (MDS), or acute myelogenous leukemia (AML)~  * Must be confirmed by bone marrow aspirate, cerebrospinal fluid exam, or blood test~ * Trisomy 21 mosaicism allowed~* Group I:~  * Diagnosis of TMD in patients no older than 90 days at initial presentation~ * Must have nonerythroid blasts (any amount) in the peripheral blood and one of the following:~    * Verification with a second sample~   * More than 5% bone marrow blasts~   * Hepatomegaly and/or splenomegaly~   * Lymphadenopathy~   * Cardiac or pleural effusions OR~ * Histologically or cytologically proven TMD with blasts in an affected organ or in fluid (pericardial, pleural, or peritoneal)~ * Bone marrow aspirate is required~* Group II (closed to accrual as of 6/24/04):~  * Diagnosis of MDS or AML (except M3 subtype) in patients older than 90 days with more than 29% blasts in bone marrow (with or without history of TMD), or any of the following histologies:~    * Refractory anemia (RA)~   * RA with excess blasts (RAEB)~   * RAEB in transformation~   * RA with ringed sideroblasts (RARS)~   * Primary cytopenia (later confirmed by bone marrow aspirate as due to marrow hypoplasia) defined by one or more of the following:~      * Absolute neutrophil count less than 500/mm\^3~     * Untransfused platelet count less than 30,000/mm\^3~     * Untransfused hemoglobin less than 8 g/dL~* The following diagnoses will be observed only:~  * RA with mild cytopenias\*~ * RARS with mild cytopenias\*~ * Mild primary cytopenias (one or more) without dysplasia (confirmed by hypoplastic bone marrow exam) NOTE: \* Platelet count 30-150,000/mm3, absolute neutrophil count 500-1,499/mm3, and hemoglobin greater than 8 g/dL~* Granulocytic sarcoma (chloroma), with or without bone marrow involvement, allowed~PATIENT CHARACTERISTICS:~Age:~* See Disease Characteristics~* 21 and under~Performance status:~* Not specified~Life expectancy:~* Not specified~Hematopoietic:~* See Disease Characteristics~Hepatic:~* See Disease Characteristics~Renal:~* Not specified~Cardiovascular:~* Shortening fraction greater than 27% by echocardiogram\* OR~* Ejection fraction greater than 47% by radionuclide angiogram\* NOTE: \*For patients with MDS and AML (as of 2/24/04, previously diagnosed MDS or AML closed to accrual; MDS or AML that develops (secondary to TMD) after study enrollment or MDS that requires initial observation \[with or without subsequent treatment\] allowed)~PRIOR CONCURRENT THERAPY:~Biologic therapy:~* Not specified~Chemotherapy:~* Prior chemotherapy for TMD allowed~* No prior chemotherapy for malignancy~Endocrine therapy:~* Concurrent topical or inhaled steroids for other conditions allowed~Radiotherapy:~* No prior radiotherapy for malignancy~Surgery:~* Not specified~Other:~* No prior antileukemic therapy~* Prior enrollment on this study for TMD allowed

- Gender: ALL
- Minimum Age: None
- Maximum Age: 21 Years
- Healthy Volunteers: f

Study Arms:
- Arm A: TMD patients only (Type: EXPERIMENTAL): Patients are observed if their transient myeloproliferative disorder (TMD) does not require intervention. Patients who require therapy for TMD undergo leukapheresis or exchange transfusion for up to 3 consecutive days. If the TMD does not resolve or there is significant organ involvement, patients receive low-dose cytarabine IV continuously on days 0-4. Treatment repeats at least every 2 weeks for up to 4 courses. Patients who experience a recurrence of TMD at least 8 weeks after resolution or have refractory disease may proceed to group II for further treatment. patients will continue to be followed for remission induction, EFS, DFS and OS regardless of the type of leukemia that develops.
- Arm B: AML/MDS patients only (Type: EXPERIMENTAL): (closed to accrual as of 6/24/04 except for patients first enrolled in group I): Patients receive induction therapy comprising cytarabine IV continuously, daunorubicin hydrochloride IV continuously, and oral thioguanine twice daily on days 0-3. Treatment repeats every 28 days for 4 courses. Patients with no CNS disease at diagnosis receive cytarabine intrathecally (IT) on day 0. Patients with CNS disease at diagnosis receive cytarabine IT on days 0, 5, and 7. If CNS disease persists on day 7, patients receive up to 6 courses of cytarabine IT, therapeutic hydrocortisone IT, and methotrexate IT, twice weekly beginning on day 10. Asparaginase during Intensification 1 day 1 hour 18.

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