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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT00462605
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of 1 of the following diseases by bone marrow aspiration and/or biopsy:
* Myelodysplastic syndromes (MDS) meeting the following criteria:
* Must have 1 of the following subtypes:
* Refractory anemia (RA) (no RA with 5q-syndrome),
* RA with ringed sideroblasts or
* Refractory cytopenia with multilineage dysplasia
* Myelodysplastic syndromes (MDS) meeting the following criteria:
Must have 1 of the following subtypes:
* Refractory cytopenia with multilineage dysplasia and ringed sideroblasts,
* RA with excess blasts (RAEB)-1, RAEB-2,
* Myelodysplastic syndromes, unclassified or
* Chronic myelomonocytic leukemia
* International Prognostic Scoring System score of intermediate-2 or high-risk
* Acute myeloid leukemia (AML) meeting 1 of the following criteria:
* Relapsed or refractory AML, including any of the following subtypes:
* \* AML with recurrent cytogenetic abnormalities (i.e., AML with 11q23 \[MLL\] abnormalities)
* AML with multilineage dysplasia
* AML that is therapy-related
* AML, not otherwise categorized (M0 \[minimally differentiated\], M1 \[without maturation\], M2 \[with maturation\], M4 \[myelomonocytic leukemia\], M5 \[monoblastic/monocytic leukemia\], M6 \[erythroid leukemia\], and M7 \[megakaryoblastic leukemia\])
* Untreated AML
* Newly diagnosed patients are eligible provided they do not qualify for potentially curative intensive chemotherapeutic regimens
* Acute lymphocytic leukemia (ALL) meeting 1 of the following criteria:
* Relapsed or refractory ALL
* Patients with any measurable residual disease are eligible, including cytogenetic abnormalities
* Untreated ALL
* Newly diagnosed patients are eligible provided they do not qualify for potentially curative intensive chemotherapeutic regimens, including any of the following:
* Patients who have refused chemotherapy for untreated ALL
* Patients who are deemed to be poor candidates medically for ALL induction chemotherapy
* Relatively stable bone marrow function for \> 7 days prior to study entry
* WBC count that has not doubled within the past 7 days
* WBC =\<10,000/mm³
* No uncontrolled peripheral leukemia (i.e., blast count \> 30,000/mm³)
* No active CNS disease
* Lumbar puncture with negative cytology required for patients with clinical symptoms of active CNS disease
* Not a candidate for a potentially curative allogeneic stem cell transplantation OR considered a poor candidate for such a procedure due to age, medical comorbidities, or lack of a suitable donor
* Hemoglobin \>= 8 g/dL (transfusions allowed)
* Creatinine =\< 2.0 mg/dL
* Bilirubin =\< 1.6 mg/dL (unless secondary to hemolysis)
* AST or ALT =\< 3 times upper limit of normal (unless disease-related)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No untreated or progressive infections
* No history of intolerance to sargramostim (GM-CSF)
* Recovered from all treatment-related toxicities
* More than 2 weeks since prior therapy for AML, ALL, or MDS, including chemotherapy, hematopoietic growth factors, or biologic therapy such as monoclonal antibodies
* Concurrent hydroxyurea allowed during course 1 for control of leukocytosis if WBC \> 30,000/mm³
* ECOG performance status 0-2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00462605
Study Brief:
Protocol Section:
NCT00462605