Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant
NCT ID: NCT06337331
Last Updated: 2024-06-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE2
Study Classification
INTERVENTIONAL
Study Start Date
2024-08-31
Study Completion Date
2027-08-31
Brief Summary
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Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter.
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Detailed Description
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Conditions
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Acute Myeloid Leukemia
Myelodysplastic Syndromes
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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High-dose Chemotherapy + Mismatched Allogeneic Stem Cell Transplant
Group Type
EXPERIMENTAL
Venetoclax
Intervention Type
DRUG
400mg/day PO Days -8 to -2
Decitabine
Intervention Type
DRUG
20mg/m2/day IV Days -7 to -3
Fludarabine
Intervention Type
DRUG
30mg/m2/day IV Days -7 to -3
Busulfan
Intervention Type
DRUG
3.2mg/kg/day IV Days -5 to -4
Total Body Irradiation
Intervention Type
RADIATION
200cGy Day -2
Interventions
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Venetoclax
400mg/day PO Days -8 to -2
Intervention Type
DRUG
Decitabine
20mg/m2/day IV Days -7 to -3
Intervention Type
DRUG
Fludarabine
30mg/m2/day IV Days -7 to -3
Intervention Type
DRUG
Busulfan
3.2mg/kg/day IV Days -5 to -4
Intervention Type
DRUG
Total Body Irradiation
200cGy Day -2
Intervention Type
RADIATION
Eligibility Criteria
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Inclusion Criteria
* Availability of a 4/8 - 6/8 HLA-matched related donor or a 7/8 HLA-matched unrelated donor
* Receiving first allogeneic transplant
* KPS \>/= 70%
* MDS associated with TP53 mutation AND R-IPSS high or very high risk at diagnosis OR
* AML with adverse risk cytogenetics or molecular abnormalities according to the 2017 ELN risk stratification OR pre-transplant MRD by either flow cytometry, cytogenetics or FISH
* Less than 5% myeloblasts in the marrow pre-transplant
* Receiving first allogeneic transplant
* KPS \>/= 70%
* MDS associated with TP53 mutation AND R-IPSS high or very high risk at diagnosis OR
* AML with adverse risk cytogenetics or molecular abnormalities according to the 2017 ELN risk stratification OR pre-transplant MRD by either flow cytometry, cytogenetics or FISH
* Less than 5% myeloblasts in the marrow pre-transplant
Exclusion Criteria
* Poor cardiac function defined as LVEF \<45%
* Poor pulmonary function defined as FEV1, FVC, or DLCO \<50% predicted
* Poor liver function defined as bilirubin \>/=2.5mg/dL, AST/ALT \>3xULN
* Poor renal function defined as creatinine \>/=2.0mg/dL or CrCl \<40mL/min
* Ongoing or active systemic infection, active Hepatitis B or C virus infection, or known HIV positivity
* Patient requiring treatment with a moderate or strong inhibitor or inducer of CYP3A4 or a P-gp inhibitor within 7 days prior to starting preparative chemotherapy through Day +4 post-transplant
* Poor pulmonary function defined as FEV1, FVC, or DLCO \<50% predicted
* Poor liver function defined as bilirubin \>/=2.5mg/dL, AST/ALT \>3xULN
* Poor renal function defined as creatinine \>/=2.0mg/dL or CrCl \<40mL/min
* Ongoing or active systemic infection, active Hepatitis B or C virus infection, or known HIV positivity
* Patient requiring treatment with a moderate or strong inhibitor or inducer of CYP3A4 or a P-gp inhibitor within 7 days prior to starting preparative chemotherapy through Day +4 post-transplant
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Northside Hospital, Inc.
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Scott Solomon, MD
Role: PRINCIPAL_INVESTIGATOR
Northside Hospital/BMTGA
Locations
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Caitlin Guzowski
Atlanta, Georgia, United States
Site Status
Countries
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United States
References
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Solomon SR, Sizemore CA, Zhang X, Brown S, Holland HK, Morris LE, Solh M, Bashey A. Impact of Donor Type on Outcome after Allogeneic Hematopoietic Cell Transplantation for Acute Leukemia. Biol Blood Marrow Transplant. 2016 Oct;22(10):1816-1822. doi: 10.1016/j.bbmt.2016.07.010. Epub 2016 Jul 21.
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RESULT
Jin S, Cojocari D, Purkal JJ, Popovic R, Talaty NN, Xiao Y, Solomon LR, Boghaert ER, Leverson JD, Phillips DC. 5-Azacitidine Induces NOXA to Prime AML Cells for Venetoclax-Mediated Apoptosis. Clin Cancer Res. 2020 Jul 1;26(13):3371-3383. doi: 10.1158/1078-0432.CCR-19-1900. Epub 2020 Feb 13.
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RESULT
DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Dohner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hajek R, Porkka K, Illes A, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.
Reference Type
RESULT
Valdez BC, Murray D, Yuan B, Nieto Y, Popat U, Andersson BS. ABT199/venetoclax potentiates the cytotoxicity of alkylating agents and fludarabine in acute myeloid leukemia cells. Oncotarget. 2022 Feb 10;13:319-330. doi: 10.18632/oncotarget.28193. eCollection 2022.
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RESULT
Garcia JS, Kim HT, Murdock HM, Cutler CS, Brock J, Gooptu M, Ho VT, Koreth J, Nikiforow S, Romee R, Shapiro R, Loschi F, Ryan J, Fell G, Karp HQ, Lucas F, Kim AS, Potter D, Mashaka T, Stone RM, DeAngelo DJ, Letai A, Lindsley RC, Soiffer RJ, Antin JH. Adding venetoclax to fludarabine/busulfan RIC transplant for high-risk MDS and AML is feasible, safe, and active. Blood Adv. 2021 Dec 28;5(24):5536-5545. doi: 10.1182/bloodadvances.2021005566.
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RESULT
Valdez BC, Tang X, Li Y, Murray D, Liu Y, Popat U, Champlin RE, Andersson BS. Epigenetic modification enhances the cytotoxicity of busulfan and4-hydroperoxycyclophosphamide in AML cells. Exp Hematol. 2018 Nov;67:49-59.e1. doi: 10.1016/j.exphem.2018.08.002. Epub 2018 Aug 10.
Reference Type
RESULT
Other Identifiers
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NSH 1401
Identifier Type: -
Identifier Source: org_study_id
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