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New treatment option for Acute Myeloid Leukemia
Official title Revumenib in Combination With 7+3 + Midostaurin in AML
ClinicalTrials.gov ID: NCT06313437
What this study is testing
What is Revumenib?
Revumenib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as SNDX-5613, Trans N-ethyl-2-((4-(7-((4-(ethylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2- yl)pyrimidin-5-yl)oxy)-5-fluoro-N-isopropylbenzamide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML). The names of the study drugs involved in this study are: Revumenib (SNDX-5613) (a type of menin inhibitor) Midostaurin (a type of multi-kinase including FLT3 inhibitor) Cytarabine (a type of antineoplastic agent) Daunorubicin (a type of antineoplastic agent)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with AML who are newly diagnosed according to the WHO 2022 Classification and previously untreated except for hydroxyurea. ATRA pretreatment...
- Patients must be ≥ 18 and \< 75 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
- Presence of FLT3-ITD and/or TKD mutation(s) AND NPM1 mutation in bone marrow or peripheral blood
- Dose escalation phase only: Presence of any of the following adverse risk genetic characteristics:
You likely can't join if
- Subject has acute promyelocytic leukemia, inversion (16), t(8;21) AML as described below. Contact Sponsor-Investigator with questions. Inversion 16...
- Subject has known active CNS involvement with AML.
- Subject has received a strong CYP3A4 inducer (APPENDIX C) within 7 days prior to the initiation of study treatment
- Strong CYP3A4 inhibitors (APPENDIX C) are contraindicated except strong CYP3A4 inhibitor antifungal azole medications (systemic itraconazole...
- QTc using Fridericia's correction [QTcF]) \> 450 msec. Drugs that prolong QTc should be avoided if possible. A list of common QTc prolonging drugs...
- Subject has tested positive for HIV (due to potential drug-drug interaction between antiretroviral medications and Midostaurin/revumenib). Note: HIV...
See the full eligibility criteria
Who can join
- Patients with AML who are newly diagnosed according to the WHO 2022 Classification and previously untreated except for hydroxyurea. ATRA pretreatment for suspected APL for less than 5 days is allowed. Eligible patients...
- Patients must be ≥ 18 and \< 75 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
- Presence of FLT3-ITD and/or TKD mutation(s) AND NPM1 mutation in bone marrow or peripheral blood
- Dose escalation phase only: Presence of any of the following adverse risk genetic characteristics:
- 2022 ELN adverse risk genetic features:
- t(6;9)(p23.3;q34.1)/DEK::NUP214
- t(v;11q23.3)/KMT2A-rearranged
- t(9;22)(q34.1;q11.2)/BCR::ABL1
- t(8;16)(p11.2;p13.3)/KAT6A::CREBBP
- inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)/ GATA2, MECOM(EVI1)
- t(3q26.2;v)/MECOM(EVI1)-rearranged
- -5 or del(5q); -7; -17/abn(17p)
- Complex karyotype, monosomal karyotype
- Mutations in either one of these genes: ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
- Mutated TP53
- NPM1 + FLT3-ITD + DNMT3A mutation
- LVEF ≥ 50% by MUGA or ECHO at screening.
- Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL/min; determined by the Cockcroft Gault formula.
- Adequate liver function as demonstrated by:
- aspartate aminotransferase (AST) ≤ 2.5 × ULN\
- alanine aminotransferase (ALT) ≤ 2.5× ULN\
- total bilirubin ≤ 1.5 × ULN\ \ Unless considered due to leukemic organ involvement. Note: people with Gilbert's Syndrome may have a total bilirubin \> 1.5 × ULN per discussion with the Sponsor-Investigator
- Resolution of adverse reactions to prior drug therapy (such as hydroxyurea) to ≤ grade 1
- Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy based on the opinion of the treating physician.
- Male people must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug.
- Females of childbearing potential (i.e., not postmenopausal for at least 1 year or not surgically sterile) must have negative results by a serum or urine pregnancy test performed within 7 days of day 1.
- Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)
- Consolidation should occur between 1-4 weeks following count recovery after induction and remission (must be confirmed by labs to document maximal response) is established. people will receive medium intensity...
- an induction response \ 1000 and PLT \>75000 for whom documented path report is submitted.
- sufficiently fit (performance status \<3)
- resolution of any adverse reactions to no greater than grade 1 severity
What rules you out
- Subject has acute promyelocytic leukemia, inversion (16), t(8;21) AML as described below. Contact Sponsor-Investigator with questions. Inversion 16 and t(8;21): CBF chromosomal abnormalities may be assessed by molecular...
- Subject has known active CNS involvement with AML.
- Subject has received a strong CYP3A4 inducer (APPENDIX C) within 7 days prior to the initiation of study treatment
- Strong CYP3A4 inhibitors (APPENDIX C) are contraindicated except strong CYP3A4 inhibitor antifungal azole medications (systemic itraconazole, ketoconazole, posaconazole, voriconazole). For strong CYP3A4 inhibitor...
- QTc using Fridericia's correction [QTcF]) \> 450 msec. Drugs that prolong QTc should be avoided if possible. A list of common QTc prolonging drugs and alternatives that are not QTc prolonging can be found in APPENDIX D.
- Subject has tested positive for HIV (due to potential drug-drug interaction between antiretroviral medications and Midostaurin/revumenib). Note: HIV testing is not required.
- Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months. (Hepatitis B or C testing is not required). people with serologic evidence of...
- Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the initiation of study treatment.
- Subject has a cardiovascular disability status of New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue...
- Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would...
- Subject has chronic respiratory disease that requires continuous oxygen use.
- Subject has a malabsorption syndrome or other condition that precludes enteral route of administration.
- Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled systemic infection.
- Subject has a history of other malignancies prior to study entry, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- Prior malignancies treated with (surgery+/- chemotherapy+/- radiation) that have remained disease free for at least two years after completion of therapy
- Subject treated with any form of chemotherapy, immunotherapy, or investigative agent within 1 month of enrollment.
- Patients who have had prior exposure to a menin inhibitor.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.