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 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT01983761
Eligibility Criteria:
Inclusion Criteria:
1. Males and females: 1 to 80 years of age
2. Patients with AML, ALL, CML, CLL, MDS, NHL or HD:
Patients with AML: first complete remission (CR1) with high-risk for relapse (e.g., high-risk cytogenetics, molecular mutation \[FLT3, MEK, MLL, other\] and/or persistent minimal residual disease by evidence of flow cytometry \< 20% blasts in marrow), secondary leukemia from prior chemotherapy and/or arising from MDS, Langerhan's cell histiocytosis, second or third complete remission (CR2 or CR3) Patients with ALL: CR1 with Philadelphia chromosome or translocation 4;11, hypodiploidy, and/or persistent minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy, CR2 or CR3 Patients with CML: second chronic phase after failure or intolerant of tyrosine kinase inhibitors, or accelerated phase Patients with MDS: IPPS INT-1 or higher and failed prior therapy Patients with NHL: CR2 or CR3 following response to prior therapy, or relapse, including relapse following autologous HSCT Patients with HD: CR2 or CR3 following response to prior therapy, or relapse, including relapse following autologous HSCT
3. KPS of 80 or ECOG \< 3 (age 12 years) or Lansky Play Performance Score of \> 60% (age \< 12 years). Eligibility for pediatric patients will be determined in conjunction with an Institutional pediatrician.
4. Laboratory data:
ALT/AST \< 2.0 times the upper limit of normal (ULN) Total bilirubin \< 2.0 times ULN Creatinine \< 1.6 mg/dL
5. Left ventricular ejection fraction (LVEF) ≥ 40%
6. Pulmonary function test (PFT) demonstrating diffusion capacity of lung for carbon monoxide (DLCO) ≥ 50% of predicted. For children \< 7 years of age who are unable to perform PFT, oxygen saturation \> 92% on room air by pulse oximetry allowed.
7. Patients must have 2 UCB unit available, each matched with the patient at 4, 5, or 6/6 collect all 10 HLA class I (serological) and II (molecular) antigens. Each UCB unit must contain a minimum dose of 1.5 x107 (red blood cell depleted) TNC per kg per cord pre-thaw. Information on HLA-C and DQ loci will be collected for future analysis.
8. Have a back-up cell source identified in case of engraftment failure. The source can be autologous, allogeneic (related or unrelated).
9. Negative beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on study
10. Patient, or guardian, ability to provide written informed consent
Exclusion Criteria:
1. Prior allogeneic transplant
2. Patients with 6/6 HLA-matched sibling donors, 10/10 HLA-matched unrelated donors (MUD), or untimely availability of 10/10 HLA-MUD relative to need to take patient to transplant
3. Active, uncontrolled infection, decompensated congestive heart failure or pulmonary insufficiency requiring oxygen supplementation
4. Active central nervous system (CNS) disease in patients with a history of CNS malignancy
5. Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements
6. Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV) or rapid plasma regain (RPR) test for syphilis
7. Pregnant or breast-feeding
8. Treatment with any investigational product within 28 days prior to Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
80 Years
Study:
NCT01983761
Study Brief:
Protocol Section:
NCT01983761