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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT00582933
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis: Acute myelogenous leukemia (AML) Acute undifferentiated leukemia (AUL); Acute lymphoblastic leukemia (ALL); Acute biphenotypic leukemia (AbiL); Chronic myelogenous leukemia (CML); Non Hodgkin's lymphoma (NHL); Myelodysplastic syndrome (MDS) Aplastic anemia (AA)
* Status: CR1 first remission; CR2 second remission; CP chronic phase
* HLA-matched Related donors: Research participants who have an HLA-matched related donor are eligible for entry on this protocol. This will include a healthy related donor who is genotypically or phenotypically matched at all A, B and DRB1 loci, as tested by DNA analysis.
* HLA-compatible Unrelated donors: Research participants who do not have a related HLA-matched donor but have an unrelated donor who is either matched at all A, B and DRB1 loci or who is mismatched at 1/6 loci (A, B, or DRB1) as tested by DNA analysis, will be eligible for entry on this protocol.
* HLA-mismatched Related donors: Research participants who do not have a related or unrelated HLA-compatible donor must have a healthy family member who is at least HLA-haplotype identical to the recipient.
* Research participants must have a healthy HLA compatible related or unrelated donor who is willing to receive G-CSF injections and undergo apheresis for PBSC collection, or undergo a marrow harvesting procedure.
* Research participants should be \< 55 years. There is no lower age limit. Research participants \> 55 years will be accrued on a case by case basis after discussion and approval by the BMT Service.
* Research participants may be of either gender or any ethnic background.
* Research participants must have a Karnofsky (adult) or Lansky (pediatric) Performance Status \> 70%
* Research participants must have adequate physical function
Exclusion Criteria:
* Active CNS or skin leukemic/lymphomatous involvement
* Female research participants who are pregnant or breast-feeding
* Active viral, bacterial or fungal infection
* Research participant seropositive for HIV-I/II; HTLV -I/II
* Research participants who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
54 Years
Study:
NCT00582933
Study Brief:
Protocol Section:
NCT00582933