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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00087204
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of 1 of the following:
* Acute myeloid leukemia
* Myelodysplastic syndromes, including 1 of the following:
* Refractory anemia with excess blasts (RAEB)
* RAEB in transformation
* Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood or bone marrow blasts
* Acute lymphoblastic leukemia
* Chronic myelogenous leukemia in blastic phase
* Relapsed or refractory disease, defined as 1 of the following:
* Failed to achieve a complete response (CR) to a standard induction regimen
* Relapsed after achieving a CR
* Failed last cytotoxic regimen before study entry
* No alternate, potentially curative option available
* No known CNS disease
* Performance status - ECOG 0-2
* SGOT and SGPT normal
* Bilirubin normal
* Creatinine normal
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV-positive patients with normal CD4 count and without AIDS-defining disease allowed
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue (XL119)
* No concurrent uncontrolled illness
* No active or ongoing infection
* No psychiatric illness or social situation that would preclude study compliance
* No prior allogeneic stem cell transplantation
* No concurrent prophylactic hematopoietic colony-stimulating factors (CSF)
* No epoetin alfa or hematopoietic CSF during course 1 of study therapy
* More than 7 days since prior cytotoxic chemotherapy except for hydroxyurea
* More than 7 days since prior radiotherapy
* Recovered from all prior therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer agents or therapies
* No other concurrent antileukemic agents or therapies
* No other concurrent investigational agents or therapies
* No other concurrent cytotoxic agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00087204
Study Brief:
Protocol Section:
NCT00087204