Study on Ponatinib for Patients with Chronic Myelogenous Leukemia in Molecular Response

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What is this study about?

This clinical trial is focused on studying Chronic Myelogenous Leukemia (CML), a type of cancer that affects the blood and bone marrow. The treatment being tested is a medication called Ponatinib, which is taken as a film-coated tablet. The purpose of the study is to evaluate the effectiveness of reintroducing and then stopping treatment with Ponatinib in patients who have achieved a specific level of response to their previous treatment.

Participants in the study will take Ponatinib orally, which means they will swallow the tablets. The study will observe how well patients maintain their response to the treatment over a period of time. The study will also monitor any new or worsening side effects that may occur during the treatment. The goal is to see how many patients can maintain their response without the need for continuous treatment.

The study will last for a set period, during which patients will be regularly monitored to assess their health and response to the treatment. This includes checking for any adverse events, such as blood-related issues or digestive problems, and ensuring that the disease does not progress. The study aims to provide insights into the potential for patients to live without ongoing treatment while maintaining their health.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

You will undergo a series of initial assessments to confirm eligibility, including a review of your medical history and a physical examination.

2 initial assessments

You will have an electrocardiogram (ECG) to check your heart’s electrical activity. The QTcF interval, which measures the time it takes for your heart to recharge between beats, must be within normal limits.

A pregnancy test will be conducted for females of childbearing potential to ensure safety before starting the study.

3 medication administration

You will begin taking the study medication, ponatinib, in the form of Iclusig 15 mg film-coated tablets. This medication is taken orally.

The dosage and frequency of the medication will be determined by the study team and will be explained to you in detail.

4 regular monitoring

Throughout the study, you will have regular visits to monitor your health and response to the medication. This includes blood tests and other assessments as needed.

You will be asked to report any side effects or changes in your health to the study team immediately.

5 evaluation of response

The main goal is to evaluate the proportion of patients who maintain a major molecular response (MMR) within 52 weeks after stopping the medication.

Your progress will be closely monitored to assess the effectiveness of the treatment and any potential side effects.

6 completion of the study

At the end of the study period, you will undergo a final assessment to evaluate your overall health and the study’s outcomes.

You will receive information about any follow-up care or additional steps needed after the study concludes.

Who Can Join the Study?

Male or female patients who are at least 18 years old.
Have an ECOG Performance Status of 0, 1, or 2. ECOG Performance Status is a scale used to assess how a patient’s disease is progressing, including their level of functioning and ability to care for themselves.
Have a diagnosis of BCR-ABL positive and Ph+ CML-Chronic Phase. BCR-ABL positive and Ph+ CML refer to specific genetic markers and phases of chronic myelogenous leukemia.
Patients who have failed the first attempt of TKI discontinuation and, after TKI reintroduction, have achieved and maintained MR4 for more than one year. TKI stands for tyrosine kinase inhibitors, a type of medication, and MR4 is a level of response to treatment.
Patients who are able to take oral therapy.
Have adequate end organ function, which means:
- Direct bilirubin is less than or equal to 1.5 times the upper limit of normal (ULN).
- SGOT (AST) and SGPT (ALT) are less than or equal to 2.5 times ULN. These are liver enzymes.
- Serum lipase and amylase are less than or equal to 1.5 times ULN. These are enzymes related to digestion.
- Alkaline phosphatase is less than or equal to 2.5 times ULN. This is another enzyme related to liver function.
- Serum creatinine is less than or equal to 1.5 times ULN. This is a measure of kidney function.
Have the following electrolyte values at or above the lower limit of normal (LLN) or corrected to normal with supplements before the first dose of study medication:
- Potassium
- Magnesium
- Total calcium (corrected for serum albumin)
Have normal marrow function, which means:
- Absolute Neutrophil Count (ANC) is at least 1.5 x 10⁹/L. Neutrophils are a type of white blood cell.
- Platelets are at least 100 x 10⁹/L. Platelets help with blood clotting.
- Hemoglobin is greater than 9 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
Patients with preexisting, well-controlled diabetes can be included.
Have a normal QTcF interval on screening ECG evaluation, defined as QTcF of less than or equal to 450 ms in males or less than or equal to 470 ms in females. QTcF is a measure of heart rhythm on an ECG.
Have a negative pregnancy test documented before enrollment (for females of childbearing potential).
Be willing and able to comply with scheduled visits and study procedures.
Have the ability to understand and sign the informed consent form.
Written informed consent must be obtained before any screening procedures.

Who Cannot Join the Study?

Patients with any other type of cancer besides chronic myelogenous leukemia cannot participate.
Patients who are not in the age range specified for the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with severe heart problems cannot participate.
Patients who have had a recent heart attack cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients with severe liver or kidney disease cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had an organ transplant cannot participate.
Patients with a history of drug or alcohol abuse cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital General Universitario Morales Meseguer	Murcia	Spain
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Idkwtycs Choupo Dzvwrcpbiqwlmzhnm	L'hospitalet De Llobregat	Spain
Fjozsrdnr Pefs Ld Ioqcbgicbxdbs Blhcsmhba Dtz Hjvobxoc Uszayqlbtwipw Li Ppc	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	17.01.2020

Trial locations

Investigated drugs:

Ponatinib

Ponatinib is a medication used in this clinical trial. It is designed to treat a type of blood cancer called chronic myeloid leukemia (CML). Ponatinib works by blocking certain proteins that help cancer cells grow. In this study, the researchers are exploring how well patients respond to stopping and restarting Ponatinib treatment. The goal is to see if patients can maintain a good response to the treatment even after taking a break from it.

Chronic myelogenous leukemia – Chronic myelogenous leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as myeloid cells. The disease progresses slowly and can remain in a chronic phase for several years. Over time, it may advance to an accelerated phase, where the number of abnormal cells increases. Eventually, it can progress to a blast crisis phase, resembling acute leukemia, with a rapid increase in immature white blood cells. This progression can lead to symptoms such as fatigue, weight loss, and an enlarged spleen.

Trial ID:

2023-508993-27-00

Protocol code:

FCR173011/ResToP

NCT ID:

NCT04160546

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Ponatinib for Patients with Chronic Myelogenous Leukemia in Molecular Response

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?