Clinical Trial: Alemtuzumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Alemtuzumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis

Brief Summary: The goal of this clinical research study is to learn the if the drug combination of alemtuzumab, etoposide and dexamethasone can help to control HLH. The safety of the drug combination will also be studied.

Detailed Summary:

Study Treatment:

If you are found to be eligible to take part in this study, you will receive the study treatment in 2 parts. The first part of the study will last about 8 weeks (Weeks 1-8) and will be called the "induction phase". The second part of the study will start after the induction phase and will last about 16 weeks (Weeks 9-16). This part will be called the "maintenance phase". However, the parts of the study may be longer or shorter depending on if/how the disease responds to the treatment, how the biomarkers react to treatment, and what the doctor thinks is in your best interest.

You will receive alemtuzumab by vein or through an injection under the skin every day on Days 1-4 of the induction phase and about 1 time every 4 weeks during the maintenance phase.

You will receive etoposide by vein about 1 time each week during the induction phase. You will not receive it in the maintenance phase unless the disease stops responding to the study drugs. At that point, you may begin to receive etoposide again. The study doctor will tell you more about this.

The length of time it takes to infuse the study drugs will be different from patient to patient and will depend on rate of injection. Your doctor will discuss this with you.

You will receive dexamethasone by vein on Days 1-7 of the induction phase. After this, you will take pills of dexamethasone every day during the induction phase. In the maintenance phase, you will take these pills 3 times each week with at least a day between each dose (for example, Monday, Wednesday, and Friday).

Your dose of the study drugs may be raised, lowered, and/or delayed
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Overall Response Rate (ORR) of Alemtuzumab in Combination with Etoposide and Dexamethasone in Participants with Hemophagocytic Lymphohistiocytosis (HLH). [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: March 5, 2015
Date Started: September 23, 2015
Date Completion: September 2018
Last Updated: February 10, 2017
Last Verified: February 2017