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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07358195
Eligibility Criteria:
Recipient Inclusion Criteria:
* Patient ages 18-70
* Underlying hematological malignancy which is deemed as being potentially curable with allogeneic bone marrow or PBSC transplantation by the BMT voting team.
* Hematological malignancies include, but are not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS. Patient should be in a partial (PR) or complete remission (CR) at the time of the transplant.
* Existence of an HLA-matched or haploidentical relative who passes standard donor evaluations for bone marrow and kidney donation
* LVEF \> 40% as measured by echocardiography or MUGA
* FEV1, FVC, and DLCO \> 50% of predicted as measured by standard PFTs
* Total bilirubin \< 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all \< 5x institutions upper limit of normal
* ABO compatibility in the host vs. graft direction
* Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 1 year following the transplant.
* Participants should be on dialysis or have a CrCl ≤ 35 ml/min
* Life expectancy greater than 6 months
* Recipient ability to understand and provide informed consent
Donor Inclusion Criteria:
* HLA matched or haploidentical relative as defined by 3/6, 4/6, or 5/6 HLA-matched at HLA -A, -B, or -DRB1 who is 18-70 years of age
* ECOG performance status 0 or 1
* Excellent health per conventional pre-donor history (medical and psychosocial evaluation)
• Acceptable laboratory parameters (hematology in normal or near-normal range; liver function \< 3 times the upper limit of normal and normal creatinine)
* Compatible ABO blood group
* Negative donor lymphocyte cross match
* No positive testing for active viral infection (Hepatitis B, Hepatitis C, HIV)
* Donor ability to understand and provide informed consent
* Meets standard institutional criteria for both bone marrow or peripheral blood stem cell (PBSC) and kidney donation
Exclusion Criteria:
* Active serious infection
* Participation in other investigational drug use at the time of enrollment
* Positivity for active infection with HIV, HCV, or HBV
* ABO blood group incompatibility in the host-vs-graft direction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07358195
Study Brief:
Protocol Section:
NCT07358195