Daratumumab for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
In this study, the investigators are hypothesizing that daratumumab-hyaluronidase will effectively treat T-ALL in patients who have persistent or recurrent MRD following treatment with chemotherapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy for Grafts Versus Host Disease (GVHD), you may not be eligible, except for prednisone at a dose of 10 mg or less per day.
Is Daratumumab safe for human use?
How is the drug Daratumumab unique for treating leukemia?
Daratumumab is unique because it is a monoclonal antibody that targets the CD38 protein, which is highly expressed on certain cancer cells, and it works by triggering the immune system to attack these cells. While it is primarily used for multiple myeloma, its novel mechanism of action and ability to be administered intravenously or subcutaneously make it a promising option for other conditions like leukemia.678910
What data supports the effectiveness of the drug Daratumumab for leukemia?
Daratumumab has shown effectiveness in treating multiple myeloma, a type of blood cancer, by helping about one-third of patients respond to treatment and improving survival when used alone or with other drugs. While this data is specific to multiple myeloma, it suggests potential benefits for other blood-related conditions like leukemia.6791011
Who Is on the Research Team?
Shira Dinner, MD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
This trial is for people with T-cell ALL who still have cancer cells after chemotherapy (MRD ≥ 10-4). They can't be pregnant or breastfeeding, must not have severe heart disease, active brain cancer involvement, uncontrolled HIV/HBV/HCV infections, or need strong drugs for GVHD. Good organ function and a performance status of 0-2 are required.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 weekly doses of daratumumab-hyaluronidase
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of MRD status on Day 64
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
Daratumumab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eastern Cooperative Oncology Group
Lead Sponsor
Janssen, LP
Industry Sponsor
Joaquin Duato
Janssen, LP
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen, LP
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University