Down Sendromu ve Akut Miyeloid Lösemi veya Miyelodisplastik Sendromu Olan Genç Hastaların Tedavisinde Kombinasyon Kemoterapisi

Sade dilde özet

Bu çalışma, Down sendromu (Down syndrome) ile birlikte akut miyeloid lösemi (acute myeloid leukemia) veya miyelodisplastik sendrom (myelodysplastic syndromes) bulunan çocuk hastalarda birden fazla kemoterapi ilacının birlikte kullanımını incelemektedir. Çalışmaya, yeni tanı almış ve Down sendromu bulunan genç hastalar katılabilmiştir. Children's Oncology Group tarafından yürütülen çalışma Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Children's Oncology Group

Müdahale

asparaginase, daunorubicin hydrochloride, cytarabine, thioguanine, etoposide, laboratory biomarker analysis

Başlangıç

01.03.2007

Tahmini bitiş

31.12.2021

Ülkeler

United States, Australia, Canada, Puerto Rico

İlgili genler

Merkezler

• Phoenix, United States
• Downey, United States
• Long Beach, United States
• Los Angeles, United States
• Madera, United States
• Oakland, United States
• Oakland, United States
• Orange, United States
• Palo Alto, United States
• San Diego, United States
• San Francisco, United States
• Aurora, United States
• Wilmington, United States
• Washington D.C., United States
• Washington D.C., United States
• Fort Lauderdale, United States
• Hollywood, United States
• Jacksonville, United States
• Orlando, United States
• St. Petersburg, United States
• Atlanta, United States
• Honolulu, United States
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• Chicago, United States
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• Peoria, United States
• Springfield, United States
• Indianapolis, United States
• Indianapolis, United States
• Indianapolis, United States
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• Bangor, United States
• Baltimore, United States
• Baltimore, United States
• Bethesda, United States
• Ann Arbor, United States
• Detroit, United States
• Detroit, United States

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Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Diagnosis DS or DS mosaicism by karyotype or chromosomal analysis
* Diagnosis of myelodysplastic syndromes (MDS) with \< 30% blasts or acute myeloid leukemia (AML)

  * Newly diagnosed disease
* Patients with a history of transient myeloproliferative disorder (TMD) are eligible provided the patient is diagnosed with AML or MDS at \> 90 days of age AND meets either of the following criteria:

  * At least 30% blasts in the bone marrow regardless of time since resolution of TMD
  * More than 8 weeks since resolution of TMD with ≥ 5% blasts in the bone marrow
* Immunophenotype required for study entry
* No promyelocytic leukemia
* Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT \< 2.5 times ULN
* Creatinine adjusted according to age as follows:

  * No greater than 0.4 mg/dL (≤ 5 months)
  * No greater than 0.5 mg/dL (6 months -11 months)
  * No greater than 0.6 mg/dL (1 year-23 months)
  * No greater than 0.8 mg/dL (2 years-5 years)
  * No greater than 1.0 mg/dL (6 years-9 years)
  * No greater than 1.2 mg/dL (10 years-12 years)
  * No greater than 1.4 mg/dL (13 years and over \[female\])
  * No greater than 1.5 mg/dL (13 years to 15 years \[male\])
  * No greater than 1.7 mg/dL (16 years and over \[male\])
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
* No evidence of dyspnea at rest
* No exercise intolerance
* Pulse oximetry \> 94%
* No prior chemotherapy, radiotherapy, or any antileukemic therapy

  * Intrathecal cytarabine therapy given at diagnosis allowed
* Prior therapy for TMD allowed