Adult T-cell Leukemia-LymphomaPhase 2NCT02737046
Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma
A Phase 2 study testing Belinostat, Zidovudine and Interferon-Alfa-2b in people with Adult T-cell Leukemia-Lymphoma and ATLL, run by University of Miami at 1 site in United States.
Trial summary
The investigators propose to use Belinostat in combination with AZT as consolidation therapy for the treatment of ATLL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult T-cell Leukemia-Lymphoma, ATLL
- What is being tested?
- Belinostat, Zidovudine and Interferon-Alfa-2b
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2016to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented adult T-cell leukemia/lymphoma (ATLL) with the following characteristics:
- Any stage of disease,
- Aggressive types (for definition of ATLL subtypes see Appendix H),
- Documented presence of ATLL cells in peripheral blood by either morphology, histology, flow cytometry or gene rearrangement studies.
- One of the following:
- Initiated AZT/IFNα therapy prior or at the time of enrollment. OR;
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- Received chemotherapy or other antineoplastic drug therapy ≥ 2 weeks prior to enrollment with the exception of dose-reduced vincristine/and or cyclophosphamide, or high dose steroids, administered for cytoreductive purpose. (Note: Continuation of zidovudine and interferon therapy is allowed.).
- Presence of ATLL based on morphology, histology, flow cytometry, or T-cell clonality in peripheral blood during screening period prior enrollment.
- Documented Human T-cell lymphotropic virus type 1 (HTLV-1) infection: Documentation may be serologic assay (ELISA) confirmed by Western blot or polymerase chain reaction (PCR).
- Measurable or evaluable disease, including presence of ATLL by immunophenotyping from either histology or flow cytometry studies, or molecular disease as evidence by T-cell clonality detected by gene rearrangement studies.
- 18 years of age or older.
- Karnofsky performance status (KPS) ≥ 50% or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
- Patients must have adequate end organ and bone marrow function as defined below:
- absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 [Exception: Unless cytopenias are secondary to ATLL]
- platelets (PLT) ≥ 50,000 cells/mm3 [Exception: Unless cytopenias are secondary to ATLL]
- Adequate hepatic function:
- transaminase ≤ 2.5 the institutional upper limit of normal (ULN),
- total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN), [Exception: Unless secondary to hepatic infiltration with lymphoma. If the elevated bilirubin is felt to be secondary to Indinavir or Atazavinir therapy (or anti-HIV medications), patients will be allowed to enroll.]
- Creatinine clearance (CrCl) ≥ 40 mL/min, [Exception: Unless secondary to renal involvement by lymphoma is suspected.]
- Patients who are human immunodeficiency virus positive (HIV+) are also eligible.
- Females of childbearing potential (CBP) must have a negative serum pregnancy test within one week of enrollment. Women should avoid pregnancy while receiving study treatment. Males and females must agree to use adequate birth control during participation in this trial and for 3 months after completing therapy.
- Patients receiving erythropoietin or Granulocyte-colony stimulating factor (G-CSF) from baseline are eligible.
Who cannot join
- Patients with progressive disease (after previous chemotherapy or AZT/IFNα) at the time of enrollment.
- Patients with chronic leukemia with favorable features, or smoldering type ATLL.
- Patients receiving any other investigational agents within 14 days prior to initiation of study therapy. (Exception: Patients actively receiving IFN-alfa-2b, PEG-IFN-alfa-2b, or similar forms of IFN-alfa are permitted).
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that are likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
- Pregnant or breast-feeding women.
- Known hypersensitivity to histone deacetylases (HDACs), zidovudine, belinostat or any component of the formulation(s).
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- Acute hepatitis or decompensated liver disease unless due to lymphoma. Chronic hepatitis will be required to be on prophylactic treatment during the study if provided liver function test meet criteria listed above without evidence of cirrhosis to be eligible.
- Concurrent active malignancies, with the exception of in situ carcinoma of the cervix, non-metastatic, non-melanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy.
- Known New York Heart Association (NYHA) Class 3 or 4 heart disease as per Appendix D.
- Known ejection fraction < 45% or institutional limit of normal range
- Psychological, familial, sociological or geographical conditions likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Belinostat as Consolidation Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma
The investigators propose to use Belinostat in combination with AZT as consolidation therapy for the treatment of ATLL.
- Conditions
- Adult T-cell Leukemia-Lymphoma, ATLL
- Being tested
- Belinostat, Zidovudine, Interferon-Alfa-2b, Pegylated Interferon-Alfa-2b, Lymphodepleting Therapy
- Medical subject headings
- Leukemia-Lymphoma, Adult T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelinostatDrug
Also called PXD101, Beleodaq®
Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1- 5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
ZidovudineDrug
Also called AZT
Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO), three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
Interferon-Alfa-2bDrug
Also called IFN-α-2b
OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Pegylated Interferon-Alfa-2bDrug
Also called PEG-IFN-α-2b
OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
Lymphodepleting TherapyDrug
Also called Cyclophosphamide
OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.
| Study group | Role | What they receive |
|---|---|---|
| Belinostat + Zidovudine | Experimental | 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) Receives: Drug: Belinostat; Drug: Zidovudine; Drug: Interferon-Alfa-2b; Drug: Pegylated Interferon-Alfa-2b; Drug: Lymphodepleting Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Complete Molecular Response in Blood Compartment (CMR)
Number of participants achieving Complete Molecular Response after receiving protocol therapy will be reported. Complete Molecular Response (CMR) is defined as the disappearance of malignant clone(s), as proven by negative T-cell receptor gene rearrangement studies of peripheral blood DNA and bone marrow. CMR will be evaluated based upon T-cell clonality studies to be conducted while subjects are on Belinostat, and while subjects are receiving Zidovudine (AZT)-based maintenance treatment (after Belinostat completion).
Measured: From end of cycle 3 until at least end of month 12
Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events
Number of participants experiencing treatment-related serious adverse events (SAEs), and adverse events (AEs). SAEs and AEs will be assessed by and assigned severity and treatment attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03.
Measured: Up to 13 months
Secondary outcomes (6)
Number of Participants Achieving Clinical Response
Number of participants achieving complete response (CR) or partial response (PR) to study therapy will be reported. Response is assessed on the basis of clinical, radiologic, molecular and pathologic (i.e. bone marrow) criteria.
Measured: Up to 12 months
Failure-Free Survival (FFS) Rate at 12 Months Using Kaplan-Meier Method
The Failure-Free Survival (FFS) rate at 12 months estimated by the Kaplan-Meier method will be reported as a percentage probability of participants alive without documented disease progression, relapse after response or death (by any cause) at 12 months after starting study therapy. FFS is defined as the elapsed time in months from study treatment initiation until documented disease progression, relapse after response or death (by any cause, in the absence of progression). In the failure-free subjects, FFS will be censored at the last documented date of failure-free status.
Measured: 12 months
Overall Survival (OS) Rate at 12 Months Using Kaplan-Meier Method
The Overall Survival (OS) rate at 12 months estimated by the Kaplan-Meier method will be reported as the percentage probability of survival beyond 12 months. OS is defined as the elapsed time from study treatment initiation to death or date of censoring. Subjects alive or those lost to follow-up will be censored at the last date known to be alive.
Measured: 12 months
Number of Participants Exhibiting Disruption of HTLV-1 Latency in Vivo
The number of participants exhibiting disruption of Human T-lymphotropic virus 1 (HTLV-1) latency in vivo after receiving Belinostat therapy will be reported. HTLV-1 latency will be evaluated from serum blood samples.
Measured: Up to 13 months
Number of Participants Exhibiting Cytotoxic T-Cell Response in Vivo
The number of participants exhibiting cytotoxic T-Cell response in vivo after receiving Belinostat therapy will be reported. Cytotoxic T-Cell response will be evaluated from serum blood samples.
Measured: Up to 13 months
HTLV-1 Pro-Viral Load Among Participants
HTVL-1 pro-viral load among study participants will be reported as a measure of HTLV-1 infected reservoirs in vivo after receiving Belinostat therapy. HTLV-1 viral load will be evaluated from serum blood samples
Measured: Up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start12 Dec 2016
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult T-cell Leukemia-LymphomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan C. Ramos, MD, University of Miami
- Investigators
- Juan C Ramos, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737046
- Sponsor's protocol ID
- 20150567
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2016
- Last updated
- 10 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Belinostat as Consolidation Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma
- ClinicalTrials.gov ID
- NCT02737046
- Acronym / sponsor ID
- 20150567
- Conditions
- Adult T-cell Leukemia-Lymphoma, ATLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Posted 10 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to use Belinostat in combination with AZT as consolidation therapy for the treatment of ATLL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belinostat + Zidovudine | Experimental | Drug: Belinostat, Drug: Zidovudine, Drug: Interferon-Alfa-2b, Drug: Pegylated Interferon-Alfa-2b, Drug: Lymphodepleting TherapyBelinostat + 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically or cytologically documented adult T-cell leukemia/lymphoma (ATLL) with the following characteristics:
- One of the following:
- Presence of ATLL based on morphology, histology, flow cytometry, or T-cell clonality in peripheral blood during screening period prior enrollment.
- Documented Human T-cell lymphotropic virus type 1 (HTLV-1) infection: Documentation may be serologic assay (ELISA) confirmed by Western blot or polymerase chain reaction (PCR).
- Measurable or evaluable disease, including presence of ATLL by immunophenotyping from either histology or flow cytometry studies, or molecular disease as evidence by T-cell clonality detected by gene rearrangement studies.
Key exclusion criteria (11 listed)
- Patients with progressive disease (after previous chemotherapy or AZT/IFNα) at the time of enrollment.
- Patients with chronic leukemia with favorable features, or smoldering type ATLL.
- Patients receiving any other investigational agents within 14 days prior to initiation of study therapy. (Exception: Patients actively receiving IFN-alfa-2b, PEG-IFN-alfa-2b, or similar forms of IFN-alfa are permitted).
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that are likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
- Pregnant or breast-feeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelinostatAlso: PXD101, Beleodaq®Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1- 5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles. | Drug | Belinostat + Zidovudine |
| ZidovudineAlso: AZTZidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO), three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12. | Drug | Belinostat + Zidovudine |
| Interferon-Alfa-2bAlso: IFN-α-2bOPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. | Drug | Belinostat + Zidovudine |
| Pegylated Interferon-Alfa-2bAlso: PEG-IFN-α-2bOPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. | Drug | Belinostat + Zidovudine |
| Lymphodepleting TherapyAlso: CyclophosphamideOPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy. | Drug | Belinostat + Zidovudine |
Primary outcome
Number of Participants Achieving Complete Molecular Response in Blood Compartment (CMR)
Time frame: From end of cycle 3 until at least end of month 12
Number of participants achieving Complete Molecular Response after receiving protocol therapy will be reported. Complete Molecular Response (CMR) is defined as the disappearance of malignant clone(s), as proven by negative T-cell receptor gene rearrangement studies of peripheral blood DNA and bone marrow. CMR will be evaluated based upon T-cell clonality studies to be conducted while subjects are on Belinostat, and while subjects are receiving Zidovudine (AZT)-based maintenance treatment (after Belinostat completion).
Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events
Time frame: Up to 13 months
Number of participants experiencing treatment-related serious adverse events (SAEs), and adverse events (AEs). SAEs and AEs will be assessed by and assigned severity and treatment attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03.
6 secondary outcomes
Number of Participants Achieving Clinical Response
Time frame: Up to 12 months
Failure-Free Survival (FFS) Rate at 12 Months Using Kaplan-Meier Method
Time frame: 12 months
Overall Survival (OS) Rate at 12 Months Using Kaplan-Meier Method
Time frame: 12 months
Number of Participants Exhibiting Disruption of HTLV-1 Latency in Vivo
Time frame: Up to 13 months
Number of Participants Exhibiting Cytotoxic T-Cell Response in Vivo
Time frame: Up to 13 months
HTLV-1 Pro-Viral Load Among Participants
Time frame: Up to 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan C Ramos, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belinostat, Zidovudine and Interferon-Alfa-2b in people with Adult T-cell Leukemia-Lymphoma and ATLL, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving Complete Molecular Response in Blood Compartment (CMR) (time frame: From end of cycle 3 until at least end of month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.