Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT00357305
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of 1 of the following:
* Relapsed or refractory acute myeloid leukemia (AML)
* Patients with acute promyelocytic leukemia t(15;17) must have failed prior tretinoin and arsenic trioxide-containing regimen
* Must be refractory to both agents with absence of durable hematologic response OR relapsed after a complete response duration of \< 6 months
* Relapsed or refractory acute lymphoblastic leukemia
* Chronic myelogenous leukemia in accelerated or blastic phase
* Must be refractory to treatment with imatinib mesylate or dasatinib
* Disease progression despite continued treatment with imatinib mesylate or dasatinib
* Patients in accelerated or blastic phase are eligible if unable to tolerate imatinib mesylate provided their disease has progressed on dasatinib or if unable to tolerate dasatinib
* AML arising in the setting of underlying myelodysplastic syndromes (MDS) and/or myeloproliferative disorders (MPD)
* Secondary or therapy-related AML
* No active CNS leukemia
* Leukostasis OR leukemic blast count \> 50,000/mm³ allowed provided patient is treated with emergency leukapheresis or hydroxyurea to reduce leukemic blast count to \< 30,000/mm³
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* Creatinine ≤ 2.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of cytarabine-related neurotoxicity
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat (SAHA) or other agents used in the study
* No other uncontrolled illness, including, but not limited to, any of the following:
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situation that would preclude compliance with study requirements
* Infection allowed provided patient is receiving active treatment
* No HIV positivity
* See Disease Characteristics
* Recovered from prior therapy
* Persistent alopecia, fingernail discoloration, or hematologic abnormalities (primarily related to underlying disease) \> 4 weeks after last course of chemotherapy or radiotherapy does not exclude patient
* At least 2 weeks since prior valproic acid or any other histone deacetylase inhibitor
* No more than 3 prior courses of induction/reinduction chemotherapy, including induction and consolidation therapy or induction therapy after any bone marrow transplantation or similar procedure
* Prior low-dose azacitidine, growth factors, cytokines, thalidomide, interferon, or imatinib mesylate for treatment of preceding MDS/MPD do not count as prior induction/reinduction therapy
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas \[e.g., carmustine\] or mitomycin C) or radiotherapy
* At least 24 hours since prior hydroxyurea
* At least 2 weeks since prior imatinib mesylate, hematopoietic growth factors, and biological agents
* At least 4 weeks since prior autologous stem cell transplantation
* Prior allogeneic stem cell transplantation allowed if all of the following criteria are met:
* At least 90 days since prior transplant
* No evidence of graft-vs-host disease
* At least 2 weeks since prior immunosuppressive therapy
* No other concurrent anticancer agents or therapies
* No other concurrent investigational agents
* Concurrent hydroxyurea or leukapheresis allowed on days 1-10 of study treatment to control rising leukemic blasts (blasts \> 30,000/mm³) or leukostasis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00357305
Study Brief:
Protocol Section:
NCT00357305