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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT02441803
Eligibility Criteria:
Inclusion Criteria:
1. Patients age 18-60 years.
2. Patients with diagnosis of AML, judged primary refractory after up to 2 courses of AML induction therapy (\> 5% blasts on day 21 (+/-7 days) bone marrow aspirate and/or biopsy from the beginning of induction chemotherapy, up to 42 days).
3. Eastern Cooperative Oncology Group (ECOG) Performance Status \</= 2.
4. Adequate major organ function:, defined as: a) Serum creatinine \</= 3 mg/dL; b) Total bilirubin \</= 2.5 mg/dL; c) ALT (SGPT) \</= 3 x ULN or \</= 5 x ULN if related to disease; d) Cardiac ejection fraction \>/= 40% (by either ECHO or MUGA).
5. Willingness to have an allogeneic transplant.
6. Patient or patient's legal representative able to provide written informed consent.
7. Patients are required to meet the following criteria to proceed to AHSCT:
8. Donor criteria: Availability of a donor either an HLA matched sibling donor (MSD) or a haploidentical (5-9/10 HLA matched); alternatively a 8/8 HLA matched unrelated donor (MUD) by high resolution typing is immediately available;
9. Disease criteria: Day 21 (+/-7 days) bone marrow aspiration or biopsy from the beginning of salvage DCIA: a. In complete morphologic remission with \<5% bone marrow blasts, or b. Aplastic (\<10% bone marrow cellularity), and cytopenic with an absolute neutrophil count (ANC) less than 1,000/µL, or c. Low disease burden with \< 30% BM blasts, with recovery of peripheral blood (PB) WBC (ANC\>1,000/µL) and \<5% circulating blasts.
10. Adequate organ function criteria: a. Serum creatinine clearance \>/= 50 ml/min (calculated by Cockcroft-Gault formula); b. Total bilirubin \</= 2 times upper limit of normal (x ULN) (3 x ULN if considered to be due to leukemic involvement or Gilbert's syndrome); c. Alanine aminotransferase (ALT) \</= 3 x ULN (5.0 x ULN if considered to be due to leukemic involvement); d. LVEF \>/= 40% on ECHO or MUGA; e. DLCO \>/= 50% predicted after correction for hemoglobin (must be performed in patients with history of smoking or lung disease;); DLCO may be omitted in patients without history of pulmonary disease if approved by the Study Chair.
11. No active infection: Patients should be afebrile. If present, pulmonary infiltrates or other sites of infection must be improving on antibiotics. Patients should not require oxygen. Study Chair will be the arbiter of this criterion.
Exclusion Criteria:
1. HIV positive; active hepatitis B or C.
2. Uncontrolled active infections (viral, bacterial, and fungal); the Study Chair will be the final arbiter of this criterion.
3. Patients with active secondary malignancy unless approved by the Study Chair.
4. Liver cirrhosis.
5. Active CNS involvement within the previous 2 months.
6. Prior induction therapy with DAC + CIA.
7. Positive pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
8. Breast feeding women.
9. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
10. Inability to comply with medical therapy or follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02441803
Study Brief:
Protocol Section:
NCT02441803