Trial · NCT01193842
Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas
NCT01193842, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2018-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas. Trials, record NCT01193842. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01193842
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas
- NCT number
- NCT01193842
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
AIDS-Related Plasmablastic Lymphoma, AIDS-Related Primary Effusion Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma, Ann Arbor Stage I Grade 3 Follicular Lymphoma, Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma, Ann Arbor Stage II Grade 3 Non-Contiguous Follicular Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Grade 3 Follicular Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Grade 3 Follicular Lymphoma, HIV Infection, Plasmablastic Lymphoma, Primary Effusion Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Grade 3 Follicular Lymphoma
- Interventions
- Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, Laboratory Biomarker Analysis, Pharmacological Study, Prednisone, Rituximab, Vincristine Sulfate, Vorinostat
- First posted
- 2010-09-02
- Last updated
- 2023-11-21
- Results first posted
- 2018-06-12
- Limitations and caveats
- Experimental Arm C (VR-CHOP) was discontinued early in phase I due to low accrual; only 2 participants received VR-CHOP.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II) | Up to 6 months | Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study. In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH). |
| Primary | Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) | Up to 5 years | The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy. |
| Primary | Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I) | 21 days | Recommended phase II dose of vorinostat is defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the recommended phase II dose is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle. |
| Secondary | Change in CD8 Cell Counts (Phase I) | Baseline up to 12 months | Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts. |
| Secondary | Changes in Absolute CD4 Cell Counts (Phase I) | Baseline up to 12 months | Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts. |
| Secondary | Changes in Epstein-Barr Virus (EBV) Viral Load | Baseline up to 12 months | Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load. |
| Secondary | Changes in Human Herpes Virus (HHV)-8 Viral Load | Baseline up to 12 months | Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load. |
| Secondary | Changes in Human Immunodeficiency Virus (HIV) Viral Load | Baseline up to 12 months | Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values. |
| Secondary | Event-free Survival (EFS) (Phase II) | 1 year | The percentage of participants surviving without events (relapse or death) one year after starting treatment. |
| Secondary | Overall Survival (OS) (Phase II) | 1 year | The percentage of participants surviving one year after starting treatment. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II) | Up to 6 months | Reviewed responses from participants who completed at least one cycle of treatment. In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH).~In phase I, patients in DA-R-EPOCH were not included in the analysis. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) | Up to 5 years | Eligible randomized participants | percentage of participants | NUMBER |
| PRIMARY | Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I) | 21 days | Eligible Phase I Arm A (VR-DA-EPOCH) participants who completed at least 1 cycle of treatment. This arm includes participants treated at 300 mg once a day (n=6) or 400 mg once a day (n=6) of Vorinostat for days 1-5. | Mg per day of Vorinostat | NUMBER |
| SECONDARY | Change in CD8 Cell Counts (Phase I) | Baseline up to 12 months | Eligible participants who returned for follow-up with evaluable data. | cells/mm^3 | MEDIAN |
| SECONDARY | Changes in Absolute CD4 Cell Counts (Phase I) | Baseline up to 12 months | Eligible participants who completed at least 1 cycle of treatment with evaluable data. | cell/mm^3 | MEDIAN |
| SECONDARY | Changes in Epstein-Barr Virus (EBV) Viral Load | Baseline up to 12 months | Median Change from the baseline and IQR were calculated. The measurement unit is IU/mL. | IU/mL | MEDIAN |
| SECONDARY | Changes in Human Herpes Virus (HHV)-8 Viral Load | Baseline up to 12 months | Outcome measure is the difference between the baseline and specific time points (End of Cycle 2, Treatment discontinuation, 6-month, and 12-month follow-ups.~Only a few differences can be calculated. | copies per 100uL | MEDIAN |
| SECONDARY | Changes in Human Immunodeficiency Virus (HIV) Viral Load | Baseline up to 12 months | Phase II participants who returned for follow-up with evaluable data. | median change in copies per mL | MEDIAN |
| SECONDARY | Event-free Survival (EFS) (Phase II) | 1 year | Eligible randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) (Phase II) | 1 year | Eligible randomized participants. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II) | Phase II: VR-DA-EPOCH | 67.5 | 95% Confidence Interval 50.9 to 81.4 | percentage of participants | |
| Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II) | Phase II: DA-R-EPOCH | 76.2 | 95% Confidence Interval 60.6 to 88.0 | percentage of participants | |
| Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) | Phase II: VR-DA-EPOCH | Death | 28.9 | percentage of participants | |
| Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) | Phase II: DA-R-EPOCH | Death | 20.0 | percentage of participants | |
| Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) | Phase II: VR-DA-EPOCH | Life-threatening | 37.8 | percentage of participants | |
| Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) | Phase II: DA-R-EPOCH | Life-threatening | 28.9 | percentage of participants | |
| Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) | Phase II: VR-DA-EPOCH | Severe | 20.0 | percentage of participants | |
| Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) | Phase II: DA-R-EPOCH | Severe | 31.1 | percentage of participants | |
| Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) | Phase II: VR-DA-EPOCH | Moderate | 8.9 | percentage of participants | |
| Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) | Phase II: DA-R-EPOCH | Moderate | 17.8 | percentage of participants |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 results by groupParticipant flow75
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I: VR-DA-EPOCH, Dose Level (DL) 1 | STARTED | Phase I: VR-DA-EPOCH, Dose Level 1 | 3 | |
| Phase I: VR-DA-EPOCH, Dose Level (DL) 1 | STARTED | Phase I: VR-DA-EPOCH, Dose Level 2 | 0 | |
| Phase I: VR-DA-EPOCH, Dose Level (DL) 1 | STARTED | Phase I: VR-CHOP, Dose Level 1 | 0 | |
| Phase I: VR-DA-EPOCH, Dose Level (DL) 1 | STARTED | Phase II: VR-DA-EPOCH | 0 | |
| Phase I: VR-DA-EPOCH, Dose Level (DL) 1 | STARTED | Phase II: DA-R-EPOCH | 0 | |
| Phase I: VR-DA-EPOCH, Dose Level (DL) 1 | COMPLETED | Phase I: VR-DA-EPOCH, Dose Level 1 | 3 | |
| Phase I: VR-DA-EPOCH, Dose Level (DL) 1 | COMPLETED | Phase I: VR-DA-EPOCH, Dose Level 2 | 0 | |
| Phase I: VR-DA-EPOCH, Dose Level (DL) 1 | COMPLETED | Phase I: VR-CHOP, Dose Level 1 | 0 | |
| Phase I: VR-DA-EPOCH, Dose Level (DL) 1 | COMPLETED | Phase II: VR-DA-EPOCH | 0 | |
| Phase I: VR-DA-EPOCH, Dose Level (DL) 1 | COMPLETED | Phase II: DA-R-EPOCH | 0 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 participant flowAdverse events735
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 | Anemia | Blood and lymphatic system disorders | Phase I: VR-DA-EPOCH, Dose Level 1 | 2 | 7 | |
| other | Anemia | Blood and lymphatic system disorders | Phase I: VR-DA-EPOCH, Dose Level 2 | 4 | 7 | |
| other | Anemia | Blood and lymphatic system disorders | Phase I: VR-CHOP, Dose Level 1 | 1 | 2 | |
| other | Anemia | Blood and lymphatic system disorders | Phase II: VR-DA-EPOCH | 27 | 45 | |
| other | Anemia | Blood and lymphatic system disorders | Phase II: DA-R-EPOCH | 23 | 46 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Phase I: VR-DA-EPOCH, Dose Level 1 | 1 | 7 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Phase I: VR-DA-EPOCH, Dose Level 2 | 0 | 7 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Phase I: VR-CHOP, Dose Level 1 | 0 | 2 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Phase II: VR-DA-EPOCH | 3 | 45 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Phase II: DA-R-EPOCH | 0 | 46 |
1 to 10 of 735Source ClinicalTrials.gov
See all 735 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: VR-DA-EPOCH, Dose Level 1 | 2 | 7 |
| Total, all-cause mortality | Phase I: VR-DA-EPOCH, Dose Level 2 | 1 | 7 |
| Total, all-cause mortality | Phase I: VR-CHOP, Dose Level 1 | 0 | 2 |
| Total, all-cause mortality | Phase II: VR-DA-EPOCH | 13 | 45 |
| Total, all-cause mortality | Phase II: DA-R-EPOCH | 9 | 46 |
| Total, other adverse events | Phase I: VR-DA-EPOCH, Dose Level 1 | 7 | 7 |
| Total, other adverse events | Phase I: VR-DA-EPOCH, Dose Level 2 | 6 | 7 |
| Total, other adverse events | Phase I: VR-CHOP, Dose Level 1 | 2 | 2 |
| Total, other adverse events | Phase II: VR-DA-EPOCH | 43 | 45 |
| Total, other adverse events | Phase II: DA-R-EPOCH | 43 | 46 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32430507 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA121947 | Consortium for Advancing Management and Prevention of Cancer in People with HIV | SPARANO, JOSEPH A. | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL CANCER INSTITUTE | 2015 to 2025 |
Source NIH RePORTER
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/NCT01193842
GET https://conductscience.org/api/trials/v1/NCT01193842/results?page=2