Romidepsin Maintenance After Allogeneic Stem Cell Transplantation
brief summary
The goal of this clinical research study is to learn if giving romidepsin before and after a stem cell transplant in combination with fludarabine and busulfan can help to control leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin that can be given with this combination. The safety of this combination and the safety of giving romidepsin after a stem cell transplant will also be studied. This is an investigational study. Romidepsin is FDA approved and commercially available for the treatment of CTCL in patients who have received at least 1 systemic (affecting the whole body) therapy before. Busulfan and fludarabine are FDA approved and commercially available for use with a stem cell transplant. The use of the combination of romidepsin, busulfan, and fludarabine to treat the type of leukemia or lymphoma you have is considered investigational. Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
detailed description
Study Parts and Study Drug Dose Levels:
If you are found to be eligible to take part in this study, you will start Part 1 of the study. During Part 1, you will receive the study drugs before having a stem cell transplant. If the disease is well controlled after the transplant and you are still eligible, you will start Part 2. During Part 2, you will continue to receive romidepsin. The study treatments given in each part are described in more detail below.
The dose of romidepsin you receive will depend on when you join this study. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of romidepsin is found.
All participants will receive the same dose level of fludarabine. Busulfan dose levels are explained below.
Study Drug Administration and Transplant (Part 1):
The days before you receive the stem cell transplant are called minus days. The day you receive the stem cell transplant is called Day 0. The days after you receive the stem cell transplant are called plus days.
On Days -13 and -12, you will receive busulfan by vein over 3 hours. Blood (about 1 teaspoon each time) will then be drawn for pharmacokinetic (PK) testing up to 11 times over the 11 hours after the first busulfan dose. PK testing measures the amount of study drug in the body at different time points. The study staff will tell you more about the PK testing schedule. The test results will help the doctor decide what dose of busulfan you will receive during the study.
A heparin lock line will be placed in your vein before the PK testing to lower the number of needle sticks needed for these draws. If for any reason it is not possible for the PK tests to be performed, you will receive the standard dose of busulfan.
On Day -7, you will be admitted to the hospital.
On Day -6 through -3, you will receive romidepsin by vein over 4 hours, fludarabine by vein over 1 hour, and then busulfan by vein over 3 hours. PK testing up to 11 times over 11 hours will also be performed on Day -6 if the doctor thinks it is needed.
If you are going to be receiving a transplant from a matched unrelated donor, you will also receive antithymocyte globulin (ATG) by vein over 4 hours on the 3 days before the transplant. This drug is designed to further weaken your immune system to reduce the risk of rejecting of the transplant.
official title
Romidepsin Therapy in Conditioning and Maintenance in Patients With T-Cell Malignancies Receiving Allogeneic Stem Cell Transplant