Belinostat + Zidovudine for Adult T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
The investigators propose to use Belinostat in combination with AZT as consolidation therapy for the treatment of ATLL.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking investigational agents, you must stop them 14 days before starting the study, unless you are on certain types of interferon, which are allowed.
Is the combination of Belinostat and Zidovudine safe for humans?
Zidovudine, also known as AZT or Retrovir, has been used in treating HIV and is generally safe, but it can cause side effects like anemia (low red blood cell count) and neutropenia (low white blood cell count). These side effects are more common in patients with advanced disease, but with careful monitoring, they are manageable. There is no specific safety data available for the combination of Belinostat and Zidovudine.12345
How is the drug combination of Belinostat and Zidovudine unique for treating adult T-cell lymphoma?
The combination of Belinostat and Zidovudine is unique because Belinostat is a histone deacetylase inhibitor that has shown promise in treating relapsed or refractory peripheral T-cell lymphoma, while Zidovudine, typically used for viral infections, has been associated with improved survival in adult T-cell leukemia/lymphoma. This combination targets the cancer cells in a novel way by using both a cancer-specific drug and an antiviral medication.678910
What data supports the effectiveness of the drugs Belinostat and Zidovudine for treating adult T-cell lymphoma?
Belinostat has shown promise in treating relapsed or refractory peripheral T-cell lymphoma, with an overall response rate of 25.8% in a clinical trial, and it is approved by the FDA for this use. Zidovudine, when combined with interferon, showed limited effectiveness in a small study for adult T-cell leukemia/lymphoma, with only one patient showing a major response.68101112
Who Is on the Research Team?
Juan C Ramos, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
Adults with Adult T-Cell Leukemia-Lymphoma (ATLL) who have had some treatment and a partial response can join. They must be over 18, have certain blood counts and liver/kidney function, not be pregnant or breastfeeding, agree to use birth control, and cannot have other serious health issues or another active cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Consolidation Therapy
Participants receive Belinostat in combination with Zidovudine (AZT) as consolidation therapy
Maintenance Therapy
Participants receive standard Zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b or Pegylated Interferon-Alfa-2b
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Belinostat
- Zidovudine
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor