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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT00005804
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven hematologic malignancy of 1 of the following types:
* Chronic myelogenous leukemia (CML) in chronic, accelerated, or blast\* phase
* Acute leukemia with high-risk features at diagnosis such as:
* Philadelphia chromosome-positive acute lymphocytic leukemia\*\*
* Acute myeloid leukemia with high-risk cytogenetics such as inv (3), t(3;3) del(5q), -5, del(7q), -7, +8, +11, abnormal 12p, del(20q), -20, or complex abnormalities\*\*
* Acute leukemia with failure after one course of induction chemotherapy
* Acute leukemia in first relapse\* or second remission
* High-risk lymphoblastic lymphoma in first remission
* Non-Hodgkin's lymphoma, Hodgkin's disease, or other malignant lymphoproliferative disease after first remission, if an autologous transplantation is not indicated
* Myelodysplastic or myeloproliferative syndromes ineligible for Protocol FHCRC-179 NOTE: \* For patients with acute leukemia in relapse or CML in blast crisis, the search for an unrelated donor begins only if: High probability that the patient's medical condition will remain stable for the 3 to 6-month period needed to find a donorAn attempt at remission induction has been undertaken Referring physician and patient accept possibility that search for donor will be canceled if patient's condition worsens
NOTE: \*\* For newly diagnosed patients with high-risk acute leukemia, early referral is encouraged so that an unrelated donor search may begin immediately
* Availability of an unrelated donor with:
* 1 HLA-A or B non-cross-reactive group (non-CREG) mismatch (except in CML in chronic phase or myelodysplastic syndrome) OR
* 1 HLA-A or B CREG mismatch OR
* An HLA-A, B, and C match with an HLA-DRB1 or DQB1 mismatch (no double mismatch) if 1 of the above 2 donor types unavailable
* No more than 1 HLA-A, B, and C mismatch
* No availability of an HLA-identical sibling or haploidentical relative incompatible for 0 or 1 HLA-A or B locus of the nonshared haplotypes
* For patients with diagnosis other than CML in chronic phase, 1 HLA-DR locus-incompatible related donor has priority over an HLA compatible or class IA or B CREG locus antigen-incompatible unrelated donor
* No severe aplastic anemia
* No leukoencephalopathy
PATIENT CHARACTERISTICS:
Age:
* Under 51
* Eligible for transplantation until age 52 if the donor is identified prior to patient's 51st birthday
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* No severe hepatic disease, including acute hepatitis
Renal:
* Creatinine less than 2 times normal
Cardiovascular:
* No cardiac insufficiency requiring treatment
* No symptomatic coronary artery disease
Pulmonary:
* No severe hypoxemia (i.e., PO2 less than 70 mm Hg) with decreased DLCO (i.e., DLCO less than 70% predicted) OR
* No mild hypoxemia (i.e., PO2 less than 80 mm Hg) with severely decreased DLCO (i.e., DLCO less than 60% predicted)
* No pulmonary fibrosis
Other:
* No other nonmalignant disease that would severely limit life expectancy
* HIV negative
* No contraindication to total body irradiation (TBI)
* Patients excluded from this study because of contraindication to TBI may be treated on protocol FHCRC-739
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy greater than 3,000 cGy to whole brain
* At least 6 months since prior involved-field radiotherapy greater than 1,500 cGy to chest or abdomen
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
50 Years
Study:
NCT00005804
Study Brief:
Protocol Section:
NCT00005804