Akut Miyeloid Lösemili Yaşlı Hastaların Tedavisinde Sorafenib Tosilat ve Kemoterapi

Sade dilde özet

Bu çalışma, Akut Miyeloid Lösemi (Acute Myeloid Leukemia, AML) olan yaşlı hastalarda Sorafenib Tosilat ilacını kemoterapiyle birlikte inceliyor. WHO kriterlerine göre AML tanısı doğrulanmış (belirli alt tipler hariç) hastalar dahil edilmiştir. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

National Cancer Institute (NCI)

Müdahale

Biopsy, Bone Marrow Aspiration, Cytarabine, Daunorubicin Hydrochloride, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration, Sorafenib Tosylate

Başlangıç

01.04.2011

Tahmini bitiş

15.04.2021

Ülkeler

United States

İlgili genler

Merkezler

• Lewes, United States
• Newark, United States
• Orlando, United States
• Chicago, United States
• Evanston, United States
• Fort Wayne, United States
• Iowa City, United States
• Augusta, United States
• Bangor, United States
• Baltimore, United States
• Elkton, United States
• Boston, United States
• Boston, United States
• Boston, United States
• Battle Creek, United States
• Big Rapids, United States
• Grand Rapids, United States
• Grand Rapids, United States
• Grand Rapids, United States
• Muskegon, United States
• Reed City, United States
• Traverse City, United States
• Columbia, United States
• St Louis, United States
• Lebanon, United States
• Camden, United States
• Lake Success, United States
• Lake Success, United States
• Manhasset, United States
• New Hyde Park, United States
• New York, United States
• Syracuse, United States
• Goldsboro, United States
• Kinston, United States
• Winston-Salem, United States
• Columbus, United States
• Norman, United States
• Oklahoma City, United States
• Pittsburgh, United States
• Charleston, United States

+3

Uygunluk kriterleri

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

Inclusion Criteria:

* Unequivocal histologic diagnosis of AML according to World Health Organization (WHO) criteria, EXCLUDING:

  * Acute promyelocytic leukemia t(15;17)(q22;q12); promyelocytic leukemia (PML)-retinoic acid receptor, alpha (RARA)
  * Acute myeloid leukemia with t(8;21)(q22;q22); runt-related transcription factor 1 (RUNX1-RUNXT1) as determined by the Ohio State University (OSU) Molecular Reference Laboratory, per CALGB 20202
  * Acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16(p13.1;q22); core-binding factor, beta subunit (CBFB)-myosin, heavy chain 11, smooth muscle (MYH11) as determined by the OSU Molecular Reference Laboratory, per CALGB 20202
* AML patients with an antecedent hematologic disorder are eligible for treatment on this trial provided that they have not received chemotherapy, including lenalidomide, azacitidine or decitabine for their hematologic disorder; patients with therapy-related AML are eligible if there had been no further exposure to chemotherapy or radiation therapy for \> 3 years and their primary malignancy is in remission
* FLT3 mutation (ITD or point mutation) determined by the OSU Molecular Reference Laboratory, per CALGB 20202
* No prior chemotherapy for AML with the following exceptions:

  * Emergency leukapheresis
  * Emergency treatment for hyperleukocytosis with hydroxyurea
  * Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
  * Growth factor/cytokine support
  * All-trans retinoic acid (ATRA)