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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT00003335
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed high risk malignancy including:
* Acute nonlymphocytic leukemia (ANLL) after induction failure, or in first complete remission with high risk features including stem cell or biphenotypic classification (acute myeloid leukemia (AML) M0), erythroleukemia (AML M6), acute megakaryocytic leukemia (AML M7), cytogenic markers indicative of poor prognosis, or failure to achieve complete remission after standard induction therapy
* Acute lymphocytic leukemia (ALL) or ANLL in second or subsequent remission
* Chronic myeloid leukemia (CML) in chronic phase
* CML with accelerated phase or blast crisis are eligible after reinduction chemotherapy converts disease to chronic phase
* High risk ALL in first complete remission
* Myelodysplastic syndrome with evidence of evolution to acute myeloid leukemia
* Refractory anemia with excess blasts
* Refractory anemia with excess blasts in transformation
* Non-Hodgkin's lymphoma (NHL), ANLL, or ALL with recurrent disease after autologous stem cell transplantation
* Must also meet all the following conditions:
* No HLA-ABC/DR identical related bone marrow or UCB donor
* No 5/6 antigen matched related bone marrow or UCB donor
* Condition precludes waiting to search and find a donor in the National Marrow Donor Registry
* Must have an available serologic matched umbilical cord blood unit in the New York Blood Center's Placental Blood Project
* No active CNS disease
PATIENT CHARACTERISTICS:
Age:
* Under 55 at time of umbilical cord blood transplantation
Performance status:
* Zubrod 0-1
* Karnofsky 80-100%
Life expectancy:
* At least 3 months
Hematopoietic:
* For patients with ALL or ANLL in remission, CML in chronic phase, or NHL without marrow involvement who elect to undergo autologous peripheral blood stem cell collection and storage:
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* ALT/AST no greater than 4 times normal
Renal:
* Creatinine no greater than 2.0 mg/dL
* Creatinine clearance at least 50 mL/min
Cardiovascular:
* Normal cardiac function by echocardiogram or radionuclide scan (shortening fraction or ejection fraction at least 80% of normal value for age)
Pulmonary:
* FVC and FEV\_1 at least 60% of predicted for age
* For adults:
* DLCO at least 60% of predicted
Other:
* HIV negative
* No active infections at time of autologous stem cell harvest or pretransplant cytoreduction
* Not pregnant or nursing
* Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior autologous stem cell transplantation allowed
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
54 Years
Study:
NCT00003335
Study Brief:
Protocol Section:
NCT00003335