Trial Title:
Expanded Access Program for Revumenib
NCT ID:
NCT05918913
Condition:
Relapsed/Refractory Acute Leukemia
Conditions: Official terms:
Leukemia
Conditions: Keywords:
SNDX-5613
Acute Leukemia
Refractory leukemia
Relapsed leukemia
KMT2A
NPM1
UBTF tandem duplication
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Drug
Intervention name:
Revumenib
Description:
Revumenib administered orally every 12 hours.
Other name:
SNDX-5613
Summary:
This expanded access program will provide an investigational treatment option in a
controlled clinical setting for participants who are not otherwise eligible to
participate in other Syndax-sponsored clinical studies and have no approved treatment
options.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Male or female participant aged ≥30 days.
- Not eligible for participation in an ongoing clinical study and have no approved
treatment options.
- Participant or participant's health care proxy is able and willing to provide
written informed consent and able to follow study instructions.
- Relapsed or refractory (R/R) acute leukemia, as defined by standardized criteria,
after standard of care therapy, including but not limited to 1 or 2 cycles of
intensive chemotherapy, or venetoclax combinations:
1. R/R leukemia is defined by the presence of ≥5% blasts in the bone marrow and/or
persistence or reappearance of peripheral blasts.
2. Participants with persistent leukemia after initial therapy or recurrence of
leukemia at any time after achieving a response during or after the course of
treatment (including allogeneic hematopoietic stem cell transplant [HSCT]) are
eligible.
3. Participants with isolated extra medullary disease are allowed if
extramedullary disease was confirmed with biopsy.
4. Participants previously treated on a revumenib clinical trial who are entering
the expanded access program for post-transplant maintenance because they are
not eligible to receive revumenib on trial or because the trial is closed are
not required to meet the relapse/refractory status. Participants who underwent
HSCT and are eligible to resume treatment with revumenib will be dosed with the
last revumenib tolerated dose prior to transplant.
- Acute leukemia harboring a lysine (K) methyltransferase 2A gene rearrangement
(KMT2Ar), nucleoporin 98 rearrangement, nucleophosmin 1 mutation (or mutated)
mutation or any other genetic alteration with overexpression of HOXA genes predicted
to potentially respond to menin inhibitors.
- Adequate liver, renal, and cardiac function.
- Adequate methods of contraception are required during childbearing age from the time
of enrollment through 120 days following the last study drug dose. Barrier
contraception in males and double barrier in females or other highly effective
methods of contraception.
For participants currently being treated with revumenib in a Syndax-sponsored clinical
study or Syndax investigator-sponsored trial, the following criteria must be met:
- In the opinion of the Investigator, participant demonstrated acceptable benefit from
and tolerability of the study drug.
- Participant is considered compliant with study drug and procedures.
- Participant does not meet any criteria for study drug discontinuation.
- Investigator and participant agree to continue study drug treatment.
Key Exclusion Criteria:
- Evidence of uncontrolled infection.
- Pregnant or nursing women.
- Cardiac or gastrointestinal disease.
- Graft-Versus-Host Disease (GVHD): Signs or symptoms of acute or chronic GVHD >Grade
1 within 4 weeks of enrollment. All transplant participants must have been off all
systemic immunosuppressive therapy for at least 1 week prior to enrollment and
calcineurin inhibitors for at least 1 week, with the exception of steroids.
- History of or any concurrent condition, therapy, laboratory abnormality, or allergy
to excipients that, in the Investigator's opinion, either may interfere with the
participant's participation or results in the conclusion that it is not in the best
interest of the participant to participate.
Gender:
All
Minimum age:
30 Days
Maximum age:
N/A
Locations:
Facility:
Name:
Alabama Center for Childhood Cancer And Blood Disorders, Children's of Alabama
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Available
Contact:
Last name:
Matthew Kutney
Email:
hemoncpharmacy@childrensal.org
Facility:
Name:
Phoenix Children's Hospital
Address:
City:
Phoenix
Zip:
85016
Country:
United States
Status:
Available
Contact:
Last name:
Michael Henry
Email:
mhenry@phoenixchildrens.com
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Available
Contact:
Last name:
Ibrahim Aldoss
Email:
ialdoss@coh.org
Facility:
Name:
Lucile Packard Children's Hospital-Stanford
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Available
Contact:
Last name:
Norman James Lacayo
Email:
lacayon@stanford.edu
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Available
Contact:
Last name:
Elliott Stieglitz
Email:
elliot.stieglitz@ucsf.edu
Facility:
Name:
Center for Cancer and Blood Disorders, Colorado Children's Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Available
Contact:
Last name:
Kelly Faulk
Email:
kelly.faulk@childrenscolorado.org
Facility:
Name:
HCTU, Division of Hematology, University of Colorado, Anschutz Medical Center
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Available
Contact:
Last name:
Christine McMahon
Email:
christine.mcmahon@cuanschutz.edu
Facility:
Name:
Children's Healthcare of Atlanta
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Available
Contact:
Last name:
Melinda Pauly
Email:
melinda.pauly@choa.org
Facility:
Name:
Winship Cancer Institute at Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Available
Contact:
Last name:
Martha Arellano
Email:
marella@emory.edu
Facility:
Name:
University of Chicago Medical Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Available
Contact:
Last name:
Michael Thirman
Email:
mthirman@medicine.bsd.uchicago.edu
Facility:
Name:
University of Iowa Hospitals and Clinics
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Available
Contact:
Last name:
David Dickens
Email:
david-dickens@uiowa.edu
Facility:
Name:
Dana-Farber Cancer Institute, Boston Children's Cancer and Blood Disorders Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Available
Contact:
Last name:
Jessica Pollard
Email:
jessicapollard@dfci.harvard.edu
Facility:
Name:
Children's Mercy Hospital-Kansas City
Address:
City:
Kansas City
Zip:
64108
Country:
United States
Status:
Available
Contact:
Last name:
Kevin Ginn
Email:
kginn@cmh.edu
Facility:
Name:
Siteman Cancer Center - Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Available
Contact:
Last name:
John DiPersio
Email:
jdipersi@wustl.edu
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Available
Contact:
Last name:
Chen Jing
Email:
jing.chen@hmhn.org
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
Long Island City
Zip:
10065
Country:
United States
Status:
Available
Contact:
Last name:
Eytan Stein
Email:
SteinE@mskcc.org
Facility:
Name:
Cincinnati Children's Hospital Medical Center
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Status:
Available
Contact:
Last name:
Erin Breese
Email:
Erin.Breese@cchmc.org
Facility:
Name:
Division of Hematology and Oncology, Division of Pulmonary, Critical Care and Sleep Medicine, Vontz Center for Molecular Studies
Address:
City:
Cincinnati
Zip:
45267
Country:
United States
Status:
Available
Contact:
Last name:
Bryan Hambly
Email:
hamblebc@ucmail.uc.edu
Facility:
Name:
OSU Medical Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Available
Contact:
Last name:
James Blachly
Email:
james.blachly@osumc.edu
Facility:
Name:
Doernbecher Children's Hospital, Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Available
Contact:
Last name:
Bill Chang
Email:
changb@ohsu.edu
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Available
Contact:
Last name:
Sarah Tasian
Email:
tasians@email.chop.edu
Facility:
Name:
St. Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Available
Contact:
Last name:
Dr. Hiroto Inaba
Email:
hiroto.inaba@stjude.org
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Available
Contact:
Last name:
Ghayas C Issa
Email:
GCIssa@mdanderson.org
Facility:
Name:
Memorial Hermann-Texas Medical Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Available
Contact:
Last name:
Adrian Rios
Phone:
713-829-8153
Email:
adan.rios@uth.tmc.edu
Facility:
Name:
Texas Children's Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Available
Contact:
Last name:
Eric Schafer
Email:
esschafe@texaschildrens.org
Facility:
Name:
Division of Hematology and Hematologic Malignancies, University of Utah-Huntsman Cancer Hospital
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Available
Contact:
Last name:
Paul Shami
Email:
paul.shami@utah.edu
Facility:
Name:
Seattle Children's Research Institute, Seattle Childrens Hospital
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Available
Contact:
Last name:
Katherine Tarlock
Email:
Katherine.tarlock@seattlechildrens.org
Lead sponsor:
Agency:
Syndax Pharmaceuticals
Agency class:
Industry
Source:
Syndax Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05918913
