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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT00143559
Eligibility Criteria:
Inclusion Criteria:
Eligible participants were assigned to one of two different strata dependent on diagnosis, disease status and/or past transplant experience. Both strata received the same intervention but will be followed and analyzed separately.
* Group A must have one of the following diagnosis
* Acute lymphoid leukemia (ALL) in second or subsequent remission or high risk in first remission
* Acute myeloid leukemia (AML) in remission or with ≤ 25% blasts in bone marrow
* Chronic myeloid leukemia (CML)
* Juvenile myelomonocytic leukemia (JMML)
* Myelodysplastic syndrome (MDS)
* Paroxysmal nocturnal hemoglobinuria (PNH)
* Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) in second or subsequent remission after autologous HSCT, or unable to have hematopoietic stem cells collected for autologous HSCT
* Group B must have one of the following refractory diagnosis (chemoresistant relapse or primary induction failure)
* Acute lymphoid leukemia (ALL)
* Acute myeloid leukemia (AML) ≥ 25% blast in bone marrow
* Secondary AML / MDS
* Chronic myeloid leukemia (CML) in accelerated phase or blast crisis
* Juvenile myelomonocytic leukemia (JMML)
* Myelodysplastic syndrome (MDS)
* Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) with residual disease followed by autologous HSCT or who have chemo-resistant disease
* Or patients who have undergone prior allogeneic HSCT or who have a co-morbid condition that in the medical opinion of the Transplant Faculty makes standard myeloablation prohibited
* At least 2 and less than or equal to 21 years of age
* Lacks suitable HLA-identical sibling or matched available unrelated donor and has a mismatched family member donor that is available, HIV negative and at least 18 years old
* Cardiac shortening fraction ≥ 25%
* Creatinine clearance ≥ 40 cc/min/1.73m\^2
* FVC ≥ 40% of predicted or pulse oximetry ≥ 92% on room air
* Direct bilirubin ≤ 3 mg/dL or SGPT ≤ 500 U/L
* Karnofsky or Lansky (age dependent) performance score of ≥ 50
Exclusion Criteria:
* Known allergy to murine products
* Lactating (female patient)
* Pregnancy (female patient)
* Active central nervous system (CNS) leukemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
21 Years
Study:
NCT00143559
Study Brief:
Protocol Section:
NCT00143559