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
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)
- AgeOutrightinclusion
age <= 70
Show in the text - CardiacOutrightinclusion
LVEF > 40%
Show in the text - HepaticOutrightinclusion
Total bilirubin < 2.0
Show in the text - HIVOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG > 1
Show in the text - RenalConditionalinclusion
CrCl <= 35 ml/min
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County