Akut Miyeloid Lösemi veya Yüksek Riskli Miyelodisplastik Sendromu Olan Hastaların Tedavisinde Gemtuzumab Ozogamicin veya Tipifarnib İçeren veya İçermeyen Kombinasyon Kemoterapisi

Sade dilde özet

Bu çalışma, akut miyeloid lösemi (acute myeloid leukemia) veya yüksek riskli miyelodisplastik sendrom (myelodysplastic syndromes) olan hastalarda kombinasyon kemoterapisinin, Gemtuzumab Ozogamicin veya Tipifarnib eklenerek ya da eklenmeden uygulanmasını incelemektedir. Çalışmaya, daha önce lösemi için kemoterapi almamış, akut miyeloid lösemi veya yüksek riskli miyelodisplastik sendrom tanısı olan hastalar katılabilmiştir. The University of New South Wales tarafından yürütülen çalışma Faz 2/Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

PHASE2/PHASE3

Durum

Tamamlandı

Sponsor

The University of New South Wales

Müdahale

alemtuzumab, arsenic trioxide, azacitidine, busulfan, clofarabine, cytarabine, daunorubicin hydrochloride, fludarabine phosphate, gemtuzumab ozogamicin, melphalan, tipifarnib, DNA methylation analysis, cytogenetic analysis, gene expression analysis, mutation analysis, diagnostic laboratory biomarker analysis, immunologic technique, allogeneic hematopoietic stem cell transplantation, nonmyeloablative allogeneic hematopoietic stem cell transplantation

Başlangıç

01.08.2006

Ülkeler

United Kingdom

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Uygunluk kriterleri

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

DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Acute myeloid leukemia (AML) meeting the following criteria:

    * De novo or secondary AML
    * No acute promyelocytic leukemia
  * High-risk myelodysplastic syndromes (\> 10% marrow blasts; refractory anemia with excess blasts-2)
  * No blast transformation of chronic myeloid leukemia
* Patients ≤ 60 years of age may be eligible provided they are considered unfit for clinical trial MRC-AMLI5

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* AST and ALT ≤ 2 times upper limit of normal (ULN) (for patients receiving gemtuzumab ozogamicin)
* Bilirubin ≤ 2 times ULN (for patients receiving gemtuzumab ozogamicin)
* Creatinine normal (for patients receiving clofarabine)
* No other concurrent active malignancy except basal cell carcinoma

PRIOR CONCURRENT THERAPY:

* No prior cytotoxic chemotherapy for AML

  * Hydroxyurea or similar low-dose therapy to control WBC count prior to initiation of intensive therapy allowed
* No concurrent enzyme anticonvulsants, including phenytoin, phenobarbital, primidone, carbamazepine, or oxcarbazepine (for patients receiving tipifarnib)