Trial of PCI-32765 (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma

Lymphoma Clinical Trial

Official title: A Phase I/II Trial of Ibrutinib (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma

Status Terminated

Clinical Trial Summary

The goal of this clinical research study is to find the highest tolerable dose of carfilzomib and ibrutinib that can be given to patients with relapsed or refractory MCL.

Researchers also want to learn if carfilzomib and ibrutinib can help to control the disease.

This is an investigational study. Ibrutinib is FDA approved and commercially available to treat MCL and chronic lymphocytic leukemia (CLL). Carfilzomib is FDA approved and commercially available to treat certain types of multiple myeloma. Giving carfilzomib to patients with MCL is investigational. The combination of ibrutinib and carfilzomib is investigational. The study doctor can explain how the study drugs are designed to work.

Up to 35 participants will be enrolled on this study. All will be enrolled at MD Anderson.

Clinical Trial Description

Study Drug Administration:

If you are found to be eligible for this study, you will begin the first cycle of ibrutinib and carfilzomib. Each cycle is 28 days.

Ibrutinib Dosing:

You will take 2-4 ibrutinib capsules (depending on when you enter the study) every day with 1 cup (about 8 ounces) of water. The number of capsules will depend on when you enter the study. You must take all capsules at about the same time every day, at least 30 minutes before eating or at least 2 hours after a meal. Do not open the capsules or dissolve them.

If you miss a dose, you can take it up to 6 hours after the time you would have taken it. If it is later than 6 hours, you should skip the dose and start taking the capsules at the same time as usual the next day.

If you vomit a dose and can see all of the capsules you took, you can retake the dose. If you vomited and cannot see all of the capsules, do not retake the dose. Start taking the capsules at the same time as usual the next day.

You will need to fill out diary cards with information about when you take ibrutinib. You should bring the diary cards with you to every visit.

Carfilzomib Dosing:

On Days 1, 2, 8, 9, 15, and 16 of Cycles 1-12, you will receive carfilzomib by vein over about 30 minutes. The first 2 doses you receive may be lower than later doses. This is to lower the risk of an allergic reaction.

On Days 1, 2, 15, and 16 of Cycles 13 and beyond, you will receive carfilzomib by vein over about 30 minutes.

You should drink at least 6-8 cups (8 ounces each) of water or other fluids per day, starting 2 days before your first dose and for as long as your doctor asks you to. During Cycle 1, you will receive fluids by vein before your dose of carfilzomib. If your doctor thinks it is needed, you will also receive fluids by vein before each dose of carfilzomib in Cycle 2.

Before you receive carfilzomib, you will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

During Cycle 1 and on Day 1 of Cycle 2, you will be checked for side effects for 1 hour after you receive carfilzomib.

Study Visits:

On Day 1 of all cycles:

• You will have a physical and neurological exam.

• You will have an EKG to check your heart function.

• Blood (about 2 tablespoons) will be drawn for routine tests and to see how well your blood clots.

• If your doctor thinks it is needed, you will have a PET scan to check the status of the disease.

• If your doctor thinks it is needed, you will have a bone marrow biopsy and aspiration to check the status of the disease.

• If you are able to become pregnant, blood (about 1½ tablespoons) or urine will be collected for a pregnancy test.

On Days 2, 9, and 16 of Cycles 1 and 2, blood (about 2 tablespoons) will be drawn for routine tests and to see how well your blood clots.

On Day 1 of Cycles 2, 4, and every other cycle after that until Cycle 12 and then every 3 cycles after that, you will have a CT scan to check the status of the disease.

On Day 1 of Cycles 1, 4, and every 3 cycles after that:

• You will have an EKG.

• You will have an ECHO or MUGA scan.

On Days 8 and 15 of Cycles 1 - 3:

• You will have a physical exam (Cycle 1 and Day 15 of Cycles 2 and 3 only).

• Blood (about 2 tablespoons) will be drawn for routine tests (Cycles 1 and 2, and Day 15 of Cycle 3 only).

On Day 22 of Cycle 1:

• You will have a physical exam.

• Blood (about 2 tablespoons) will be drawn for routine tests and to see how well your blood clots.

On Day 28 of Cycle 1:

• You will have an EKG.

• You will have an ECHO or MUGA scan.

If the study doctor thinks the disease has completely responded to the study treatment, the following tests and procedures will be performed to confirm the status of the disease:

You will have a colonoscopy, including a biopsy of any abnormal growths. To collect this biopsy, small amounts of tissue are removed with a cutting tool.

You will have a bone marrow biopsy. If the doctor thinks it is needed, you will have a PET scan.

The tests may be repeated any time the doctor thinks it is needed.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the long-term follow-up phone calls.

End-of-Dosing Visit:

Within about 30 days after you finish taking the study drugs:

• You will have a physical and neurological exam.

• You will have an EKG to check your heart function.

• Blood (about 3-5 tablespoons) will be drawn for routine tests and to see how well your blood clots.

• You will have a PET scan and chest x-ray to check the status of the disease.

• If your doctor thinks it is needed, you will have a CT scan to check the status of the disease.

• If your doctor thinks it is needed, you will have a bone marrow biopsy and/or aspiration to check the status of the disease.

• If your doctor thinks it is needed, you will have a colonoscopy and GI endoscopy to look for abnormal areas.

• If you are able to become pregnant, blood (about 1½ tablespoons) or urine will be collected for a pregnancy test.

Long Term Follow-Up:

After your end-of-dosing visit, the study staff will call you every 6 months for 5 years to ask how you are doing and to find out about any other treatments you have received. These calls should take about 2-3 minutes. In addition to the phone calls, your medical records may be reviewed during this time as well. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

• NCT number: NCT02269085
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 1
• Start date: April 20, 2015
• Completion date: May 29, 2018