Yükleniyor... / Loading...
Veliparib and Topotecan With or Without Carboplatin in Treating Patients With Relapsed or Refractory Acute Leukemia, High-Risk Myelodysplasia, or Aggressive Myeloproliferative Disorders
Bu çalışma, nüks etmiş veya tedaviye dirençli akut lösemi, yüksek riskli miyelodisplazi veya agresif miyeloproliferatif bozuklukları olan hastalarda Veliparib ve Topotekan ilaçlarını, Karboplatin eklenerek veya eklenmeden inceliyor. Doğrulanmış hastalığı olan, önceki tedavisi başarısız olmuş hastalar dahil edilmiştir. Faz 1 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.
Inclusion Criteria: * Pathologically confirmed diagnosis of 1 of aggressive MPD or AML out of MPD * Aggressive phase high-risk myeloproliferative disorders (i.e., polycythemia vera, essential thrombocythemia, or Ph-negative chronic myelogenous leukemia) meeting ≥ 1 of the following criteria: * Marrow blasts \> 5% * Peripheral blood blasts plus progranulocytes \> 10% * New onset or increasing myelofibrosis OR; * New onset or \> 25% increase in hepatomegaly or splenomegaly * New onset constitutional symptoms (i.e., fever, weight loss, splenic pain, or bone pain) * Patients who failed primary induction therapy or relapsed after achieving complete remission are eligible * No active CNS leukemia; patients with a history of CNS disease must be stable for \> 3 months after treatment and off steroid treatment prior to study enrollment * Chronic myelomonocytic leukemia meeting either of the following criteria: * 5-19% bone marrow blasts (aggressive) * At least 20% marrow blasts (transformation) * ECOG performance status 0-2 * No hyperleukocytosis with \>= 50,000 blasts/uL * AST, ALT, and alkaline phosphatase =\< 5 times upper limit of normal * Bilirubin =\< 2.0 mg/dL * Creatinine normal OR creatinine clearance \>= 60 mL/min * LVEF \>= 45% by MUGA or ECHO * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after completion of study therapy * No active disseminated intravascular coagulation * No active uncontrolled infection * Patients with infection that is under active treatment and controlled with antibiotics are eligible * No other life-threatening illness * No mental deficits and/or psychiatric history that would preclude giving informed consent or following protocol * No prior or current seizure disorder or a history of seizure * No more than 3 prior cytotoxic regimens * At least 3 weeks since prior cytotoxic chemotherapy * At least 2 weeks since prior radiotherapy * At least 4 weeks since prior autologous or allogeneic stem cell transplantation * No active graft-versus-host disease * At least 1 week since prior biologic therapies, including hematopoietic growth factors * At least 24 hours since prior hydroxyurea, steroids, imatinib mesylate, arsenic trioxide, interferon, or other noncytotoxic agents for blast count control * No prior ABT-888 * No other concurrent chemotherapy, radiotherapy, or immunotherapy * No concurrent antiretroviral therapy for HIV-positive patients * No other concurrent investigational or commercial agents or therapies for this cancer