Study on the Safety of CA-4948 and Ibrutinib for Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma

2 1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer called Primary Central Nervous System Lymphoma (PCNSL), which affects the brain and spinal cord. The study is testing a new treatment that combines two medications: CA-4948 and Ibrutinib. CA-4948 is an experimental drug, while Ibrutinib is a medication already used to treat certain types of blood cancers. The purpose of the study is to evaluate the safety and effects of this combination treatment in patients whose cancer has returned or did not respond to previous treatments.

Participants in the study will take the medications orally, meaning they will swallow them in the form of tablets. The study will begin with a phase where the dose of CA-4948 is gradually increased to find the safest and most effective dose. After this phase, the study will expand to include more patients to further assess the treatment’s safety and how well it works. Throughout the study, doctors will monitor participants closely for any side effects and changes in their health. The study aims to provide valuable information about the potential benefits and risks of using CA-4948 in combination with Ibrutinib for treating PCNSL.

This trial is expected to continue until 2028, allowing researchers to gather comprehensive data on the treatment’s long-term effects. Participants will undergo regular health check-ups, including tests like MRI scans, to track the progress of their condition and the impact of the treatment. The study is designed to ensure that all participants receive the best possible care while contributing to important research that could improve future treatment options for PCNSL.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, organ function, and ability to swallow oral medications.

A negative pregnancy test is required for women of childbearing potential, and participants must agree to use effective contraception during the study and for three months after the last dose.

2 initial assessment

An initial assessment is conducted to confirm the diagnosis of primary central nervous system lymphoma (PCNSL) through medical records or imaging.

Participants must have evidence of disease progression on imaging or cytology within 28 days prior to the first cycle of treatment.

3 treatment phase

The treatment involves the administration of two medications: CA-4948 and ibrutinib, both taken orally in the form of coated tablets.

The dosage and frequency of these medications are determined based on the dose escalation and expansion phases of the trial.

4 monitoring and follow-up

Participants are monitored for any adverse events, changes in vital signs, and laboratory parameters throughout the trial.

Regular assessments are conducted to evaluate the effectiveness of the treatment, including imaging and laboratory tests.

5 completion of the trial

The trial is estimated to end by August 30, 2028, with ongoing assessments to determine the long-term effects and safety of the treatment.

Participants will continue to be monitored for any late-onset side effects or changes in their condition.

Who Can Join the Study?

Must be a male or female aged 18 years or older.
Must have a life expectancy of at least 3 months.
Must have an ECOG Performance Status of 1 or less. This is a scale used to assess how a disease affects a patient’s daily living abilities.
Must be able to swallow and retain oral medications.
Must have acceptable organ function, which includes:
- ANC (a type of white blood cell count) of at least 1,000 per microliter.
- Platelet count of at least 75,000 per microliter without transfusion.
- Estimated creatinine clearance of at least 35 mL/min, which measures kidney function.
- Hemoglobin level of at least 9.0 g/dL without red blood cell transfusion.
- INR (a blood clotting test) of 1.5 or less and aPTT (another clotting test) of 1.5 times the upper limit of normal or less.
- AST or ALT (liver enzymes) of 2 times the upper limit of normal or less.
- Total bilirubin of 1.5 times the upper limit of normal or less, or 3 times the upper limit in patients with Gilbert’s syndrome.
Must have a CPK (an enzyme found in the heart, brain, and skeletal muscle) level less than 2.5 times the upper limit of normal.
For patients on cholesterol-lowering medications that can raise CPK levels, such as statins, the medication should be adjusted or replaced if possible.
Must have recovered from any side effects caused by previous cancer treatments to a mild level (Grade 1 or less).
Women of childbearing potential and men with partners who are women of childbearing potential must agree to use highly effective birth control methods during the study and for 3 months after the last dose.
Must be willing and able to provide written informed consent and comply with the study requirements.
For Part B, patients must be able to tolerate lumbar punctures, which is a procedure to collect fluid from the spine.
For Part B, patients must be able to tolerate gadolinium-enhanced MRI or contrast-enhanced CT scans, which are imaging tests used to view the brain and other parts of the body.

Who Cannot Join the Study?

Patients with a type of blood cancer that has come back or is not responding to treatment cannot participate in Part A2 of the study, as enrollment is closed.
Patients with a specific type of brain cancer called primary central nervous system lymphoma (PCNSL) are the focus of Part B of the study.
Patients who do not meet the age requirements for the study cannot participate. The study has specific age ranges for participants.
Both male and female patients are eligible, but certain conditions may exclude them from participating.
Patients who are considered part of a vulnerable population may be excluded. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with mental disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
MD Anderson Cancer Center	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Hopital Beaujon	Clichy	France
Ikmpyqtl Rbydoywln Ppv Lw Slzzih Djp Tpgfvp Dufn Anqpfuf Ifsy Smbnrq	Meldola	Italy
Avrepccsay Prlbdgze Hyzhvwjj Dl Mnbqztzjt	Marseille	France
Njecwukz Inbtsqul Odpvgggna Irw Mebvf Snsqlkmpigjbvktvfgyfmshbgevs Ipwrnqdl Bzffukan	Cracow	Poland
Uhbnbmtzgfqtsk Cvdvqoq Kyvbmujhh	Gdansk	Poland
Hubobjfa Vjel dkaegwpq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	29.09.2023
France	Recruiting	29.09.2023
Italy	Recruiting	29.09.2023
Poland	Recruiting	29.09.2023
Spain	Recruiting	29.09.2023

Trial locations

Investigated drugs:

CA-4948 is an experimental medication being tested for its safety and effectiveness in treating patients with a type of brain cancer called primary central nervous system lymphoma (PCNSL). It is taken by mouth and is being studied to understand how it works in the body, how it affects the cancer, and what side effects it might cause.

Ibrutinib is a medication that is already used to treat certain types of blood cancers. In this trial, it is being combined with CA-4948 to see if the combination is safe and more effective for patients with PCNSL. Ibrutinib works by blocking a protein that helps cancer cells grow and survive.

Investigated diseases:

Relapsed or Refractory Hematologic Malignancy – This condition refers to blood cancers that have either returned after treatment or have not responded to initial therapy. These malignancies can include various types of leukemia, lymphoma, or myeloma. The disease progresses as cancer cells continue to grow and multiply, often leading to symptoms such as fatigue, fever, and weight loss. Over time, the cancer may spread to other parts of the body, affecting organs and tissues. The progression can vary greatly depending on the specific type of hematologic malignancy and individual patient factors.

Primary Central Nervous System Lymphoma (PCNSL) – This is a rare type of non-Hodgkin lymphoma that occurs in the brain, spinal cord, or eyes. It originates from lymphocytes, a type of white blood cell, and primarily affects the central nervous system. The disease progresses as the lymphoma cells grow and form tumors, which can lead to neurological symptoms such as headaches, seizures, and cognitive changes. As the condition advances, it may cause increased pressure in the brain and further neurological impairment. The progression and symptoms can vary based on the location and size of the tumors.

Trial ID:

2024-513312-95-00

Protocol code:

CA-4948-101

NCT ID:

NCT03328078

Trial Phase:

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

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Safety of CA-4948 and Ibrutinib for Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?