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Belinostat + Zidovudine for Adult T-Cell Lymphoma

Phase 2
Recruiting
Led By Juan C Ramos, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically documented adult T-cell leukemia/lymphoma (ATLL) with any stage of disease and aggressive types
Documented presence of ATLL cells in peripheral blood by morphology, histology, flow cytometry, or gene rearrangement studies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from end of cycle 3 to end of maintenance therapy, up to 12 months
Awards & highlights

Study Summary

This trial will test a new combination therapy for ATLL consisting of Belinostat and AZT.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system, fatigue, nausea, changes in blood counts that could increase infection risk or cause bleeding problems, liver issues, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with aggressive adult T-cell leukemia/lymphoma.
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My blood tests show I have ATLL cells.
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I have been treated with AZT/IFNα for 2 weeks or more and saw improvement in my blood counts.
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I've been on chemotherapy for at least 2 weeks and my blood counts have partially improved.
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I am 18 years old or older.
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I've had high-dose steroids and my blood condition has stabilized or improved.
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My blood test shows remaining ATLL cells.
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I have been diagnosed with HTLV-1 infection.
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My cancer can be measured or evaluated, including at the molecular level.
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I can take care of myself but may not be able to do any work.
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I am not pregnant and agree to use birth control.
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I am currently taking erythropoietin or G-CSF.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from end of cycle 3 to end of maintenance therapy, up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from end of cycle 3 to end of maintenance therapy, up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events
Proportion of Participants achieving Complete Molecular Response (CMR)
Proportion of Participants with Minimal Residual Disease (MRD)
Secondary outcome measures
HTLV-1 pro-viral load
One Year Rate of Failure-Free Survival (FFS)
One Year Rate of Overall Survival (OS)
+2 more

Side effects data

From 2012 Phase 2 trial • 32 Patients • NCT00301756
88%
Fatigue
81%
Nausea
75%
Lymphocyte count decreased
72%
Constipation
3%
Abdominal pain
3%
Urinary tract infection
3%
Lower gastrointestinal hemorrhage
3%
Dyspnea
3%
Pleural infection
3%
Upper gastrointestinal hemorrhage
3%
Activated partial thromboplastin time prolonged
3%
Dehydration
3%
Pneumonitis
3%
Cytokine release syndrome
3%
Arthralgia
3%
Small intestinal obstruction
3%
Non-cardiac chest pain
3%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzyme Inhibitor Therapy)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Belinostat + ZidovudineExperimental Treatment4 Interventions
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zidovudine
2016
Completed Phase 4
~8000
Belinostat
2006
Completed Phase 2
~430

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
913 Previous Clinical Trials
411,708 Total Patients Enrolled
Juan C Ramos, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials

Media Library

Belinostat Clinical Trial Eligibility Overview. Trial Name: NCT02737046 — Phase 2
Adult T-Cell Leukemia/Lymphoma Research Study Groups: Belinostat + Zidovudine
Adult T-Cell Leukemia/Lymphoma Clinical Trial 2023: Belinostat Highlights & Side Effects. Trial Name: NCT02737046 — Phase 2
Belinostat 2023 Treatment Timeline for Medical Study. Trial Name: NCT02737046 — Phase 2
~1 spots leftby Dec 2024
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