15 Participants Needed

Belinostat + Zidovudine for Adult T-Cell Lymphoma

SL
KS
Overseen ByKarin Suarez
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Miami
Must be taking: Erythropoietin, G-CSF
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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 Miller School of Medicine

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

I have been diagnosed with aggressive adult T-cell leukemia/lymphoma.
Creatinine clearance (CrCl) ≥ 40 mL/min
HIV+ patients eligible
See 12 more

Exclusion Criteria

I do not have any other active cancers.
Conditions likely to interfere with study requirements/treatment
My liver issues are not caused by lymphoma.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consolidation Therapy

Participants receive Belinostat in combination with Zidovudine (AZT) as consolidation therapy

Up to 3 months

Maintenance Therapy

Participants receive standard Zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b or Pegylated Interferon-Alfa-2b

Up to 9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Belinostat
  • Zidovudine
Trial Overview The trial is testing Belinostat combined with Zidovudine as a follow-up therapy for ATLL. Participants will already have received some treatment for ATLL and shown improvement without new disease progression.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Belinostat + ZidovudineExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Published Research Related to This Trial

Belinostat, a histone deacetylase inhibitor, received accelerated FDA approval for treating relapsed or refractory peripheral T-cell lymphoma (PTCL) based on a trial involving 120 patients, showing an overall response rate of 25.8%.
The treatment demonstrated a median duration of response of 8.4 months, with common side effects including nausea and fatigue, and notable grade 3/4 toxicities such as anemia and thrombocytopenia.
FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma.Lee, HZ., Kwitkowski, VE., Del Valle, PL., et al.[2015]
Belinostat shows promise as a treatment for relapsed/refractory peripheral T-cell lymphomas, which typically have limited effective therapies.
In a case involving a young patient with angioimmunoblastic-type lymphoma, treatment with belinostat followed by allogeneic stem cell transplantation resulted in a complete hematologic response that has lasted over 2 years.
Complete hematologic response after belinostat treatment and allogeneic stem cell transplantation for multiple relapsed/refractory angioimmunoblastic T-cell lymphoma: A case report.Camus, V., Etancelin, P., Drieux, F., et al.[2023]
The FDA has granted accelerated approval for Beleodaq, a histone deacetylase inhibitor, specifically for patients with relapsed or refractory peripheral T-cell lymphoma.
This approval indicates that Beleodaq has shown promising efficacy in treating this type of lymphoma, which is important for patients who have not responded to previous treatments.
Beleodaq approved for rare lymphomas.[2014]

Citations

FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma. [2015]
Zidovudine and interferon therapy for adult T-cell leukaemia/lymphoma. Results of a preliminary study at UHWI-Mona. [2013]
Complete hematologic response after belinostat treatment and allogeneic stem cell transplantation for multiple relapsed/refractory angioimmunoblastic T-cell lymphoma: A case report. [2023]
Beleodaq approved for rare lymphomas. [2014]
Belinostat for the treatment of relapsed or refractory peripheral T-cell lymphoma. [2015]
Non-Hodgkin's lymphoma in patients with advanced HIV infection treated with zidovudine. [2016]
Zidovudine for the treatment of HIV infection. [2013]
Zidovudine toxicity. Clinical features and management. [2018]
Current and future trials with zidovudine. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Role of zidovudine antiretroviral therapy in the pathogenesis of acquired immunodeficiency syndrome-related lymphoma. [2021]
Belinostat in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone as first-line treatment for patients with newly diagnosed peripheral T-cell lymphoma. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Use of zidovudine and interferon alfa with chemotherapy improves survival in both acute and lymphoma subtypes of adult T-cell leukemia/lymphoma. [2013]
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