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Alert Number 297

Two New Clinical Trials With HuMax-CD20

Date: September 27, 2008

Interest in HuMax-CD20 (“ofatumumab”) continues to be high in the CLL patient community. Thus far Genmab has conducted two well publicized clinical trials using this anti-CD20 monoclonal in CLL patients:  

  1. Treating fludarabine refractory and Campath refractory / or ineligible patients with single agent Humax-CD20.  
  2. The pivotal Phase III trial using a combination of Humax-CD20 with fludarabine and cyclophosphamide (along the lines of the now famous combination FCR) in chemo naïve patients.

While researchers consolidate and analyze the data obtained from these two trials and the company gets ready to get in front of the FDA for the green light to market HuMax-CD20, two new trials have been announced that should be of interest to our patients. A brief description of the two trials is given below, excerpted from the company website.

The first new trial is a large Phase III trial. It uses a combination of Humax-CD20 with chlorambucil, in chemo naïve patients.  Since the trial uses a double arm design, half the patients will be randomized to get just chlorambucil and the other half will get chlorambucil + HuMax-CD20.  If your heart is set on getting HuMax-CD20, this is something to think about.  There is no way of guaranteeing that you will get the two drug combination, there is a 50% chance you may end up in the chlorambucil only arm of the trial!

The second new trial is a continuation of their older trial (1) above.  It is open only to patients who had participated in the earlier trial and relapsed; this new trial is an extension to see if these patients benefit from a maintenance regimen of HuMax-CD20.

I will let you know more details of these trials as I learn about them.

Be well,

Phase III CLL front line chlorambucil combination

This open-label, parallel-arm study will include 444 patients with previously untreated CLL.  Patients in the study will be randomized to receive ofatumumab in combination with chlorambucil or chlorambucil alone. Patients receiving ofatumumab in combination with chlorambucil will receive one infusion of ofatumumab at 300 mg, one infusion at 1000 mg a week later, followed by up to 11 monthly infusions at 1000 mg.  Patients will be evaluated for disease status one month following last treatment then every 3 months for 5 years.

The primary objective of the study is to evaluate the progression free survival of ofatumumab in combination with chlorambucil therapy versus chlorambucil therapy alone for the treatment of front line CLL.


Phase II CLL ofatumumab re-treatment and maintenance treatment study

This study will examine the re-treatment and maintenance treatment of refractory CLL patients who participated in the ongoing Phase III CLL study and had disease progression following at least an objective response or stable disease during a 24 week treatment period of ofatumumab.  Eligible patients will receive one infusion of ofatumumab at 300 mg followed by 7 once weekly infusions at 2000 mg.  Maintenance treatment will consist of 24 once monthly infusions of 2000 mg of ofatumumab.  The primary objective of this study is to estimate the proportion of objective responses over 52 weeks.


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