Study on the Safety and Tolerability of SNDX-5613 for Patients with Relapsed or Refractory Acute Leukemias

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for relapsed or refractory acute leukemias. These are types of blood cancers that have either returned after treatment or have not responded to previous treatments. The study is investigating a drug called Revumenib, also known by its code name SNDX-5613. This drug is being tested in different forms, including oral solutions, capsules, and tablets. The purpose of the study is to explore the safety and tolerability of Revumenib in patients with these types of leukemias.

Participants in the study will receive various doses of Revumenib to determine the most effective and safe dose. The study will also look at how the drug is processed in the body, which is known as pharmacokinetics. This includes understanding how the drug is absorbed, distributed, metabolized, and excreted. The study will be conducted in two phases. The first phase will focus on finding the right dose, while the second phase will evaluate the drug’s safety over a longer period and its ability to help patients achieve remission, which means a reduction or disappearance of signs of cancer.

The study will include patients with specific genetic changes in their leukemia, such as the MLL/KMT2A gene rearrangement or Nucleophosmin 1 (NPM1) mutation. These genetic changes can affect how the leukemia behaves and responds to treatment. The trial aims to provide valuable information on the potential benefits and risks of using Revumenib for treating these challenging forms of leukemia. Participants will be closely monitored for any side effects and changes in their health throughout the study.

1 joining the study

Upon joining the study, the patient will be assigned to a specific phase and arm based on their medical condition and previous treatments.

The study involves patients with relapsed or refractory acute leukemias, including those with specific genetic mutations.

2 phase 1: dose-escalation

The patient will receive the drug Revumenib (also known as SNDX-5613) in various forms such as oral solution, capsule, or tablet.

The purpose of this phase is to determine the safety, tolerability, and the maximum dose that can be given without severe side effects.

The patient will be monitored for any side effects and changes in their health status.

3 phase 2: dose-expansion

In this phase, the patient will continue to receive Revumenib at the dose determined to be safe in Phase 1.

The focus is on evaluating the short- and long-term safety and effectiveness of the drug.

The patient will be assessed for remission rates and any improvements in their condition.

4 medication administration

The patient will take Revumenib orally, with the form and dosage depending on the specific requirements of their assigned arm in the study.

The frequency and duration of administration will be determined by the study protocol and the patient’s response to the treatment.

5 monitoring and assessments

Throughout the trial, the patient will undergo regular health assessments, including blood tests and other necessary examinations.

The patient’s response to the medication and any side effects will be closely monitored to ensure safety and effectiveness.

6 completion of the trial

Upon completion of the trial, the patient’s overall health and response to the treatment will be evaluated.

The results will contribute to understanding the safety and effectiveness of Revumenib for treating relapsed or refractory acute leukemias.

Who Can Join the Study?

Patients must have a type of leukemia that has come back or not responded to treatment. This includes specific genetic changes in the leukemia cells, like KMT2A rearrangement or NPM1 mutation.
Patients must have finished any previous immunotherapy treatments at least 42 days ago, and certain cell therapies at least 21 days ago.
Patients must have completed any previous anti-leukemia treatments at least 14 days ago, or 5 times the length of time it takes for the drug to leave the body, whichever is shorter.
Patients must have finished any treatments with blood cell growth factors at least 7 days ago for short-acting types, and 14 days ago for long-acting types.
For Phase 1, patients must follow specific medication rules depending on the study group they are in, such as not taking certain drugs that affect how the body processes medications.
For Phase 2, patients must have a confirmed diagnosis of relapsed or refractory leukemia, which means the leukemia has returned or not responded to treatment.
Patients must be at least 6 months old. If they are to receive a specific combination treatment, they must weigh at least 35 kg (about 77 pounds).
Patients must have a certain level of physical ability, measured by performance scores that assess how well they can carry out daily activities.
Any side effects from previous treatments must have improved to a mild level, except for mild nerve damage or hair loss.
Patients must have completed any previous radiation treatments at least 60 days ago for extensive radiation, or 14 days ago for local radiation.
Patients must have completed any previous stem cell transplants at least 60 days ago, and any donor cell infusions at least 4 weeks ago.

Who Cannot Join the Study?

Patients who have not experienced a return or worsening of their acute leukemia after treatment.
Patients who have not tried other treatments for their acute leukemia without success.
Patients who are not within the specified age range for the study.
Patients who are not able to safely tolerate the study medication.
Patients who are not able to follow the study procedures or attend required visits.
Patients who have other medical conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of allergic reactions to similar medications.
Patients who have not given their consent to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Unhjfilwyt Mkqambb Crezjj Hckhvdehrutrqxfbg	Hamburg	Germany
Isdndyiz Csdtbs Dehqpwjcggyybhzer	L'hospitalet De Llobregat	Spain
Izjacgyc Rlsndxgzb Pci Ls Slriub Dso Tpcdir Diov Ahonjpe Inzf Shttzo	Meldola	Italy
Aijgrum Uffyo Sdlpvfhad Ltkayz Dw Bmjqvyz	Bologna	Italy

Trial status

Country	Status	Recruitment Start
France	Recruiting	22.12.2022
Germany	Recruiting	22.12.2022
Italy	Recruiting	22.12.2022
Lithuania	Recruiting	22.12.2022
Spain	Recruiting	22.12.2022
The Netherlands	Not recruiting	22.12.2022

Trial locations

Investigated drugs:

Revumenib

SNDX-5613 is an investigational medication being studied for its potential to treat patients with certain types of leukemia that have returned or are resistant to treatment. This includes leukemias with specific genetic changes, such as MLL/KMT2A gene rearrangement or NPM1 mutation. The study aims to find out how safe and tolerable this medication is, determine the best dose to use in future studies, and understand how the body processes the medication.

Investigated diseases:

Acute leukaemia

Relapsed or Refractory Acute Leukemias – This condition refers to a group of blood cancers that originate in the bone marrow and are characterized by the rapid growth of abnormal white blood cells. These leukemias are termed “relapsed” when they return after a period of remission and “refractory” when they do not respond to initial treatment. The disease progresses quickly, leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the overcrowding of abnormal cells in the bone marrow. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The rapid progression of these leukemias requires prompt medical attention to manage symptoms and complications.

Trial ID:

2024-513759-34-00

Protocol code:

SNDX-5613-0700

NCT ID:

NCT04065399

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Tolerability of SNDX-5613 for Patients with Relapsed or Refractory Acute Leukemias

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