Clinical trial · Interventional
Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy
NCT07358195CI-TRIAL-00101361not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective is to assess the safety of the addition of venetoclax to reduced intensity conditioning for HLA-matched and haploidentical combined HSC and kidney transplantation as measured by stable full donor hematopoiesis and absence of CTCAE grade IV or V toxicity attributable to venetoclax.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Cancer | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Kidney Failure Chronic | — | UNRESOLVED | — |
| Stem Cell Transplant | — | UNRESOLVED | — |
| Stem Cell Transplant Complications | — | UNRESOLVED | — |
| Tolerance | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hematopoietic Cell Transplantation | Procedure | — | UNRESOLVED |
| Hematopoietic Cell Transplantation Conditioning Regimen | Procedure | — | UNRESOLVED |
| Kidney Transplant | Procedure | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Recipient
- description
- Stem Cell and Kidney Transplant
- interventionNames
- Drug: Venetoclax
- Procedure: Hematopoietic Cell Transplantation Conditioning Regimen
- Procedure: Kidney Transplant
- Procedure: Hematopoietic Cell Transplantation
Primary outcomes (3)
- measure
- Incidence of full donor chimerism
- timeFrame
- 24 months
- measure
- Incidence of Grade IV Toxicity due to Venetoclax
- timeFrame
- Days -8 to Days -1
- description
- NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.