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Everolimus and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission After Previous Imatinib Mesylate
Bu çalışma, daha önce imatinib mesylate kullanmasına rağmen tam sitogenetik yanıt elde edememiş kronik faz kronik miyeloid lösemi (chronic myelogenous leukemia, CML) hastalarında everolimus ile imatinib mesylate ilaçlarının birlikte kullanımını incelemektedir. Çalışmaya, Philadelphia kromozomu pozitif olan ve en az 9 aydır imatinib tedavisi gören 18 yaş ve üzeri hastalar alınmıştır. Araştırma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
DISEASE CHARACTERISTICS:
* Histologically confirmed chronic myelogenous leukemia (CML)
* In chronic phase
* Philadelphia chromosome (Ph)-positive
* No accelerated or blastic phase
* Accelerated phase CML is defined as ≥ 15% but \< 30% blasts in peripheral blood or bone marrow OR ≥ 30% blasts and promyelocytes in peripheral blood or bone marrow provided that \< 30% blasts were present OR ≥ 20% peripheral basophils OR platelet count \< 100,000/mm\^3, unrelated to therapy
* No less than 20 metaphases in the bone marrow sample
* No evidence of complete cytogenetic response to imatinib mesylate (complete cytogenetic response defined as 0% Ph-positive cells in bone marrow)
* Receiving continuous imatinib mesylate therapy for ≥ the past 9 months
* Dosage ≥ 600 mg/day for ≥ the past 3 months
* Stable dose of 600 mg/day for ≥ the past 4 weeks
* Achieved and maintained hematological response to imatinib mesylate as defined by all of the following:
* WBC \< 20,000/mm\^3
* Basophils \< 20%
* Less than 5% myelocytes and metamyelocytes in peripheral blood
* No blasts or promyelocytes in peripheral blood
* No evidence of disease-related symptoms or extramedullary disease, including enlarged spleen or liver
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
Hepatic
* AST and ALT \< 1.5 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN (except for patients with Gilbert's disease)
* PTT \< 1.5 times ULN (except for patients on oral anticoagulation therapy)
* INR \< 1.5 times ULN (except for patients on oral anticoagulation therapy)
Renal
* Creatinine \< 1.5 times ULN
Cardiovascular
* No angina
* No New York Heart Association class III or IV cardiac disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 months after study participation
* HIV negative
* No history of non-compliance with medical regimens
* No hypercholesterolemia or hypertriglyceridemia (fasting state) ≥ grade 2 (despite lipid-lowering therapy)
* No diabetes mellitus
* No thyroid dysfunction
* No neuropsychiatric disorders
* No infection
* No other severe and/or uncontrolled medical condition that would preclude study participation
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior allogeneic, syngeneic, or autologous bone marrow transplantation or stem cell transplantation for CML
* No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa)
Chemotherapy
* No prior chemotherapy regimens used in transplantation
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Recovered from prior major surgery
Other
* No prior sirolimus in combination with imatinib mesylate
* At least 4 weeks since prior investigational agents used in combination with imatinib mesylate and recovered
* No other concurrent investigational therapies
* No other concurrent anticancer agents