Trial · NCT02737046
Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma
NCT02737046, Phase 2, Completed, University of Miami; results first posted 2026-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma. Trials, record NCT02737046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02737046
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma
- NCT number
- NCT02737046
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- University of Miami
- Conditions
- Adult T-cell Leukemia-Lymphoma, ATLL
- Interventions
- Belinostat, Zidovudine, Interferon-Alfa-2b, Pegylated Interferon-Alfa-2b, Lymphodepleting Therapy
- First posted
- 2016-04-13
- Last updated
- 2026-03-10
- Results first posted
- 2026-03-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Complete Molecular Response in Blood Compartment (CMR) | 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). |
| Primary | Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | 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. |
| Secondary | Number of Participants Achieving Clinical Response | Up to 12 months | 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. |
| Secondary | Failure-Free Survival (FFS) Rate at 12 Months Using Kaplan-Meier Method | 12 months | 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. |
| Secondary | Overall Survival (OS) Rate at 12 Months Using Kaplan-Meier Method | 12 months | 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. |
| Secondary | Number of Participants Exhibiting Disruption of HTLV-1 Latency in Vivo | Up to 13 months | 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. |
| Secondary | Number of Participants Exhibiting Cytotoxic T-Cell Response in Vivo | Up to 13 months | 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. |
| Secondary | HTLV-1 Pro-Viral Load Among Participants | Up to 13 months | 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 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving Complete Molecular Response in Blood Compartment (CMR) | From end of cycle 3 until at least end of month 12 | Participants that have received at least three (3) doses of Belinostat and Zidovudine (AZT) consolidation therapy, have evaluable disease at baseline, and at least one post-baseline molecular disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | Up to 13 months | Participants that have received at least one dose of Belinostat and Zidovudine (AZT) consolidation therapy. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Clinical Response | Up to 12 months | Participants that receive at least one dose of Belinostat and Zidovudine (AZT) consolidation therapy, have evaluable disease at baseline, and at least one post-baseline clinical disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Failure-Free Survival (FFS) Rate at 12 Months Using Kaplan-Meier Method | 12 months | Participants that received at least one dose of Belinostat and Zidovudine (AZT) consolidation therapy. | percentage probability at 12 months | NUMBER |
| SECONDARY | Overall Survival (OS) Rate at 12 Months Using Kaplan-Meier Method | 12 months | Participants that received at least one dose of Belinostat and Zidovudine consolidation therapy. | percentage probability at 12 months | NUMBER |
| SECONDARY | Number of Participants Exhibiting Disruption of HTLV-1 Latency in Vivo | Up to 13 months | |||
| SECONDARY | Number of Participants Exhibiting Cytotoxic T-Cell Response in Vivo | Up to 13 months | |||
| SECONDARY | HTLV-1 Pro-Viral Load Among Participants | Up to 13 months |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving Complete Molecular Response in Blood Compartment (CMR) | Belinostat + Zidovudine | 3 | Participants | ||
| Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | Belinostat + Zidovudine | Grade 1 or 2 Treatment-Related Serious Adverse Events (SAEs): Hematologic Events | 0 | participants | |
| Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | Belinostat + Zidovudine | Grade 1 or 2 Treatment-Related SAEs: Non-Hematologic Events | 0 | participants | |
| Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | Belinostat + Zidovudine | Grade 3 or 4 Treatment-Related SAEs: Hematologic Events | 3 | participants | |
| Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | Belinostat + Zidovudine | Grade 3 or 4 Treatment-Related SAEs: Non-Hematologic Events | 0 | participants | |
| Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | Belinostat + Zidovudine | Grade 1 or 2 Treatment-Related Adverse Events (AEs): Hematologic Events | 10 | participants | |
| Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | Belinostat + Zidovudine | Grade 1 or 2 Treatment-Related AEs: Non-Hematologic Events | 15 | participants | |
| Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | Belinostat + Zidovudine | Grade 3 or 4 Treatment-Related AEs: Hematologic Events | 11 | participants | |
| Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | Belinostat + Zidovudine | Grade 3 or 4 Treatment-Related AEs: Non-Hematologic Events | 0 | participants | |
| Number of Participants Achieving Clinical Response | Belinostat + Zidovudine | Participants achieving Complete Response (CR) | 3 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Belinostat + Zidovudine | 15 | |
| Overall Study | COMPLETED | Belinostat + Zidovudine | 1 | |
| Overall Study | NOT COMPLETED | Belinostat + Zidovudine | 14 |
Source ClinicalTrials.gov
Adverse events93
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Belinostat + Zidovudine | 3 | 15 | 3 |
| other | Acute kidney injury | Renal and urinary disorders | Belinostat + Zidovudine | 1 | 15 | 1 |
| other | Alanine aminotransferase increased | Investigations | Belinostat + Zidovudine | 2 | 15 | 3 |
| other | Alkalosis | Metabolism and nutrition disorders | Belinostat + Zidovudine | 1 | 15 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Belinostat + Zidovudine | 11 | 15 | 46 |
| other | Anorexia | Metabolism and nutrition disorders | Belinostat + Zidovudine | 1 | 15 | 2 |
| other | Anxiety | Psychiatric disorders | Belinostat + Zidovudine | 2 | 15 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Belinostat + Zidovudine | 1 | 15 | 2 |
| other | Aspartate aminotransferase increased | Investigations | Belinostat + Zidovudine | 2 | 15 | 2 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Belinostat + Zidovudine | 2 | 15 | 2 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Belinostat + Zidovudine | 11 | 15 |
| Total, other adverse events | Belinostat + Zidovudine | 15 | 15 |
| Total, serious adverse events | Belinostat + Zidovudine | 7 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02737046
GET https://conductscience.org/api/trials/v1/NCT02737046/events?page=2