Clinical Trial: Study of Blinatumomab in Richter Transformation

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase II Study of Blinatumomab in Richter Transformation

Brief Summary: The goal of this clinical research study is to learn if blinatumomab can help to control Richter Transformation (RT, a type of blood cancer). The safety of this drug will also be studied.

Detailed Summary:

Study Drug Administration:

The study has 2 study cycles. Cycle 1 is 8 weeks, followed by a 4 week break, and then Cycle 2 is 4 weeks.

If you are found to be eligible to take part in this study, you will receive blinatumomab by a central venous catheter (CVC) continuously (non-stop) for 1-2 cycles, depending on how you are responding to the study drug. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this to you in more detail, and you will be required to sign a separate consent form for this procedure.

During Cycle 1, the blinatumomab infusion will be started in the hospital. You will be in the hospital for up to 16 nights so that you can be checked for side effects. Your doctor will decide when you can leave the hospital.

Blinatumomab will be delivered by a small pump, which you will carry with you for the whole time you receive the drug. You will be given a shoulder or belt bag to hold the pump and infusion bag. You will be able to wear regular clothes, walk around, and perform daily living activities. You will be given instructions for taking a shower and other activities. There will be some things that you should not do, such as go swimming. The study staff will give you more information on activities you should not do while receiving the drug.

You will need to come to MD Anderson to have the infusion bags changed every 48 hours. The study staff will let you know when you need to return to the clinic.

You will be given standard drugs, such as dexamethasone, to help decrease the risk of side effects. You may ask the study staff for informat
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Overall Response Rate (ORR) in Richter's transformation (RT) After Initial Induction with Blinatumomab Treatment [ Time Frame: 2 months ]

ORR defined as complete remission plus partial remission. Response assessed according to revised Cheson criteria.


Original Primary Outcome: Same as current

Current Secondary Outcome: Toxicity of Blinatumomab in Richter's Transformation (RT) [ Time Frame: 4 weeks after completion of the consolidation cycle ]

Toxicity defined as grade 3 or higher cytokine release syndrome or therapy-related neurotoxicity.


Original Secondary Outcome: Same as current

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: April 14, 2017
Date Started: June 2017
Date Completion: June 2020
Last Updated: April 19, 2017
Last Verified: April 2017