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Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

ConditionsKidney Failure ChronicStem Cell TransplantStem Cell Transplant ComplicationsToleranceHematologic Cancer
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Venetoclax

    Drug

    Venetoclax 400mg orally once daily on days -8 through -1 with daily monitoring for tumor lysis syndrome. Venetoclax tablets will be swallowed (not crushed). Venetoclax dosing will not be repeated in the event of vomiting.

  • Hematopoietic Cell Transplantation Conditioning Regimen

    Procedure/Surgery

    Cytoxan Day -6 \& -5 Fludarabine Day -4, -3, -2 TBI Day -1

  • Kidney Transplant

    Procedure/Surgery

    Living donor kidney transplant

  • Hematopoietic Cell Transplantation

    Procedure/Surgery

    Donor bone marrow (target of 4 x 108 nucleated cells/kg of recipient ideal body weight) PBSC A goal dose of 5 x 106 CD34+ cells / kg of recipient actual body weight will be infused (minimum acceptable is 2 x 106 CD34+ cells / kg).

Treatment groups

3 Participants
are divided into 1 treatment group
Group A: RecipientExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Incidence of full donor chimerism

Time frame
24 months
2

Incidence of Grade IV Toxicity due to Venetoclax

NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
Days -8 to Days -1
3

Incidence of Grade V Toxicity due to Venetoclax

NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
Days -8 to Days -1

Secondary outcomes

1

Incidence of acute renal allograft rejection

Time frame
24 months
2

Incidence of delayed renal allograft rejection

Time frame
24 months
3

Incidence of acute GVHD

Time frame
24 months
4

Incidence of Chronic GVHD

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: