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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT01684150
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients aged ≥ 18 years.
2. Patients with relapsed /refractory AML, ALL, or MLL with rearrangement of the MLL gene, including 11q23 or PTD, are eligible for the expanded cohort:
* At least one prior therapy;
* Refractory disease on most recent therapy, or disease recurrence following remission on most recent therapy;
* Received and failed all known effective therapies for their disease;
* Not a candidate for allogeneic stem cell transplantation
* \> 10% blasts or biopsy-documented leukemia cutis or myeloid sarcoma.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. Patients must have the following clinical laboratory values:
* Serum creatinine ≤2 mg/dL or creatinine clearance \> 60 mL/minute;
* Total bilirubin ≤2.0 times the ULN for the institution, unless considered due to Gilbert's syndrome;
* ALT or AST ≤ twice the upper limit of normal (ULN), unless considered due to organ leukemic involvement;
* Absolute neutrophil count ≥1,000/µL (unless due to documented leukemic involvement of the bone marrow at the time of study entry)
* Platelets ≥100,000/µL (unless due to documented leukemic involvement of the bone marrow at the time of study entry).
* PT or aPTT \< 1.5 times the ULN
5. Able and willing to give written informed consent.
6. Life expectancy of at least 3 months
Exclusion Criteria:
1. Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
2. Active heart disease
3. Receiving any other standard treatment for their hematologic malignancy.
4. Receiving strong CYP3A4 inhibitors/ inducers.
5. Known history of cerebrovascular accident in the past 6 months.
6. Known bleeding diathesis.
7. Known, active (symptomatic) involvement of the central nervous system by leukemia.
8. On immunosuppressive therapy.
9. Known active infection.
10. Pregnant or nursing females.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01684150
Study Brief:
Protocol Section:
NCT01684150