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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT00686556
Eligibility Criteria:
Inclusion Criteria:
* Acute lymphoblastic leukemia
* ≥ Complete remission 2 (CR2) (adults ≥ 18 years and ≤ 55 years)
* CR2 in pediatrics (defined as \<18 years) and \<12 months duration of first remission
* ≥ CR3 or not in remission (pediatric patients \<18 years)
* T cell leukemia ≥ CR2
* Evidence of pre-transplant minimal residual disease (MRD) by flow cytometry, FISH or cytogenetics
* Myelodysplastic syndrome
* ≤ 55 years of age and ≥ 10% blasts, not responsive to hypomethylating agents and/or conventional therapy
* Acute myeloid leukemia
* Not in remission (pediatric patients \<18 years)
* Not in remission (10-30% blasts in the bone marrow for adult patients ≥18 years and ≤ 55 years)
* Evidence of pre-transplant minimal residual disease (MRD) by flow cytometry, FISH or cytogenetics
* Multiple myeloma
* No prior autologous transplant and fitting into one of the following disease categories:
* Early disease stage (CR1/PR1) with high-risk molecular features
* Early disease stage (CR1/PR1) with high-risk clinical features
* Late disease stage (CR2/PR2+) with high-risk clinical features
* Other high risk hematologic malignancies - to be approved by 2 or more hematology/oncology and BMT physicians
* Patients with prior CNS involvement are eligible provided that it has been treated and is in remission. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the protocol.
* Have acceptable organ function within 14 days of study registration defined as:
* Renal: glomerular filtration rate \> 60ml/min/1.73m2
* Hepatic: bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline phosphatase (ALP) \< 5 x upper limit of normal (ULN)
* Pulmonary function: Carbon Monoxide Diffusing Capacity corrected (DLCOcorr) \> 50% of normal, (oxygen saturation \[\>92%\] can be used in child where pulmonary function tests (PFT's) cannot be obtained)
* Cardiac: left ventricular ejection fraction ≥ 45% by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)
* Karnofsky performance status (PS) \>80% for ages 16 years and older or Lansky Play Score \>50 for \< 16 years
* An acceptable source of stem cells according to current University of Minnesota BMT program guidelines:
* UCB graft will be composed of two partially HLA matched units. Each unit must be matched at 4-6 HLA loci to the recipient and to each other. If two matched units are not available, then a single HLA 4-6 matched unit may be used if of adequate cell dose - total graft dose must be \>3 x 107 MNC/kg
* HLA-matched related donor (6/6 or 5/6 antigen match)
* HLA-matched unrelated adult donor (if previously identified)
* Women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment.
* Voluntary written consent
Exclusion Criteria:
* Active uncontrolled infection at time of enrollment or documented fungal infection within 3 months.
* Evidence of Human immunodeficiency virus (HIV) infection
* Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
* Prior myeloablative transplant within the last 6 months
* Prior total body irradiation (TBI) making total marrow irradiation (TMI) not feasible
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
55 Years
Study:
NCT00686556
Study Brief:
Protocol Section:
NCT00686556