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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT01390402
Eligibility Criteria:
Inclusion Criteria:
1. Patients who meet the following eligibility criteria are eligible for inclusion in this study. Pediatric team to assess eligibility appropriate for patient age.
2. Age \</= 70 years of age.
3. Patients with diagnosis of CML in first chronic phase or accelerated phase with less than 15% blast in the blood and bone marrow at study entry which has failed to respond adequately to imatinib by the consensus criteria of Baccarani et al: a) no hematologic remission at 3 months, b) no cytogenetic response at 6 months, c) no major cytogenetic response at 12 months, d) no complete cytogenetic response or major molecular response at \>18 months, or e) loss of a response with increasing cytogenetic or molecular evidence of disease. Or are intolerant to tyrosine kinase inhibitor therapy. Or with second or greater chronic phase (with prior transformation who respond to treatment and have \<15% blasts at study entry).
4. Histocompatible stem cell donor: Patients must have an HLA matched related or unrelated donor (HLA A, B, C and DR) willing to donate for allogeneic hematopoietic transplantation.
5. Haploidentical NK cell donor: Patients must have a haploidentical relative with the absence of a KIR-ligand (HLA molecule).
6. Performance status: Zubrod \</= 2 or Lansky PS greater or equal to 70%.
7. Cardiac function: left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
8. Pulmonary function: no symptomatic pulmonary disease. forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) \>/= 50% of expected, corrected for hemoglobin. For pediatric patients, if unable to perform pulmonary function tests (most children \< 7 years of age), pulse oximetry \>/= 92% on room air by pulse oximetry.
9. Renal function: Serum creatinine \</= 1.8mg/dl or creatinine clearance greater or equal than 40 cc/min. Creatinine for pediatric patients \</= 1.5 mg/dl or \</= 2 times upper limit of normal for age (whichever is less).
10. Liver function: Bilirubin \</= 1.5 mg/dl (unless Gilbert's syndrome), ALT or AST \</= 200 IU/ml for adults unless related to underline disease. For pediatric patients conjugated (direct) bilirubin \<2x upper limit of normal, ALT or AST \<5 times upper limit of normal.No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
11. Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent. Assent as is age appropriate.
Exclusion Criteria:
1. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
2. Pleural/pericardial effusion or ascites estimated to be \>1L
3. HIV-positive.
4. Breast feeding or pregnancy. Pregnancy means a positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
5. Known allergy to mouse proteins
6. Active hepatitis B or C infection.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
70 Years
Study:
NCT01390402
Study Brief:
Protocol Section:
NCT01390402