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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00006056
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Patients diagnosed with any of the following active but stable, or nonactive/quiescent, hemophagocytic disorders:
* Hemophagocytic lymphohistiocytosis (HLH)
* Fever greater than 38.5 degrees Celsius
* Splenomegaly (greater than 3 cm below costal margin)
* Hemophagocytosis in bone marrow or spleen or lymph nodes
* Disease may be confirmed by positive family history
* No evidence of malignancy
* Hypertriglyceridemia and/or hypofibrinogenemia
* Fasting triglycerides at least 2.0 mmol/L or at least 3 standard deviations above normal for age
* Fibrinogen no greater than 1.5 g/L or no greater than 3 standard deviations above normal
* Cytopenia (affecting at least 2 of 3 lineages in the peripheral blood)
* Hemoglobin less than 9.0 g/L
* Platelet count less than 100,000/mm3
X-linked lymphoproliferative disorder (XLP)
Two or more maternally related males manifesting at least one of the following XLP phenotypes:
* Fulminant infectious mononucleosis
* Dysgammaglobulinemia
* Malignant lymphoma/lymphoproliferative disorder
* Aplastic anemia
* Lymphoid granulomatosis/vasculitis OR
* A maternally related male in an established XLP kindred who has strong genetic (RFLP) linkage to the XLP locus
Chediak-Higashi syndrome
Partial oculocutaneous albinism (hair, skin, eyes)
Frequent bacterial infections
Large peroxidase positive granules in leukocytes of peripheral blood or bone marrow
Positive family history or parental consanguinity is supportive of the diagnosis
May not have entered accelerated phase as defined by any of the following:
* Lymphadenopathy
* Pancytopenia
* Histiocytes with hemophagocytosis in bone marrow, lymph nodes, liver, or spleen
Viral associated hemophagocytic syndrome (VAHS)
Relapsed after prior therapy or supportive care
Diagnostic criteria as for HLH
No hemophagocytic disorders secondary to underlying malignancy
Patients 35 years of age and under must have a hematopoietic stem cell donor that is one of the following:
* HLA A and B identical OR
* Single HLA A or B serologic mismatch with DRB1 identity OR
* HLA A or B serologic identity with a single DRB1 mismatch
Patients 36 to 55 years of age must have a hematopoietic stem cell donor that is one of the following:
* HLA A and B and HLA DRB1 identical OR
* Single HLA A or B serologic mismatch with DRB1 identity
Patients receiving umbilical cord blood must have an unrelated donor with no more than two antigen HLA A, B, or DRB1 mismatches
--Patient Characteristics--
Performance status: Karnofsky 70-100% OR Age less than 16 years: Lansky 50-100%
Life expectancy: Not severly limited by another disease
Hepatic: SGOT less than 3 times normal Bilirubin less than 2.5 mg/dL
Renal: Creatinine normal OR Creatinine clearance or glomerular filtration rate greater than 50% normal
Cardiovascular: If symptomatic, ventricular ejection fraction must be greater than 40% and must improve with exercise OR Shortening fraction normal on echocardiogram
Pulmonary:
* If symptomatic, DLCO greater than 45% predicted (corrected for hemoglobin)
* In children unable to perform pulmonary function testing, oxygen saturation must be greater than 95%
Other: HIV negative No significant active infections
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
55 Years
Study:
NCT00006056
Study Brief:
Protocol Section:
NCT00006056