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:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT00301769
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of 1 of the following hematologic malignancies:
* Acute myeloid leukemia
* Acute lymphoblastic leukemia
* Myelodysplastic syndromes
* Chronic myelogenous leukemia in blastic phase
* Chronic lymphocytic leukemia
* Relapsed or refractory disease
* No immediately available, potentially curable options (e.g., stem cell transplantation) available
* Bilirubin normal (unless elevated due to Gilbert's syndrome)
* HIV positivity allowed provided CD4 counts are normal with no AIDS-defining disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situations that would limit study compliance
* Recovered from prior therapy
* ECOG performance status =\< 2
* SGOT and SGPT =\< 2.5 times upper limit of normal (ULN)
* Creatinine normal OR creatinine clearance \>= 60 mL/min
* Primary resistance (i.e., failed to achieve a complete remission \[CR\] to a standard induction regimen) or relapsed after achievement of a CR.
* Must have documented failure to last cytotoxic regimen prior to study entry.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* No known CNS disease
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to SJG-136
* More than 7 days since radiotherapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other anti-leukemia agents except hydroxyurea =\< 5 grams/day =\< 14 days prior to and during first course of treatment to control blood counts
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00301769
Study Brief:
Protocol Section:
NCT00301769