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Trial NCT07358195

Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

Phase
Early phase 1
Sponsor
Massachusetts General Hospital
Conditions
Kidney Failure Chronic; Stem Cell Transplant; Stem Cell Transplant Complications; Tolerance; Hematologic Cancer
Ages
18–70 years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Recipient Inclusion Criteria: * Patient ages 18-70Age * 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 MUGACardiac * 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)Hepatic 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/minRenal * 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 1Performance status * 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 HBVHIV * ABO blood group incompatibility in the host-vs-graft direction

Restrictions found (6)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Boston, Suffolk County