Trial · NCT02232516
Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma
NCT02232516, Phase 2, Completed, Northwestern University; results first posted 2024-04-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma. Trials, record NCT02232516. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02232516
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma
- NCT number
- NCT02232516
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Hepatosplenic T-cell Lymphoma, Peripheral T-cell Lymphoma, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IA Mycosis Fungoides/Sezary Syndrome, Stage IB Mycosis Fungoides/Sezary Syndrome, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IIA Mycosis Fungoides/Sezary Syndrome, Stage IIB Mycosis Fungoides/Sezary Syndrome, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IIIA Mycosis Fungoides/Sezary Syndrome, Stage IIIB Mycosis Fungoides/Sezary Syndrome, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IVA Mycosis Fungoides/Sezary Syndrome, Stage IVB Mycosis Fungoides/Sezary Syndrome
- Interventions
- romidepsin, lenalidomide, laboratory biomarker analysis
- First posted
- 2014-09-05
- Last updated
- 2026-06-12
- Results first posted
- 2024-04-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR), as Defined Per Cheson Criteria | Assessed after cycles 3 and 6, then every 6 months up to 3 years | The endpoint for this objective will be objective response rate (ORR), defined per Cheson criteria. Response will be assessed by imaging after cycles 3 and 6, and then every 6 months thereafter. Response at 3 months (after cycle 3) will be used for purposes of the interim efficacy analysis. |
| Secondary | Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Evaluated once per cycle (1 cycle=28 days) up to 1 year. | The frequency and severity of toxicity events will be evaluated. All adverse events will be summarized as to type, severity, frequency, timing and attribution. Grade 3 or greater AEs that occurred in at least 10% of the patients are reported here |
| Secondary | Progression-free Survival (PFS) | Reported at 1 and 3 years after the start of treatment | l be progression-free survival (PFS) 1 and 3 years after start of treatment as well as the duration of response from start of therapy, defined per Cheson criteria. |
| Secondary | Overall Survival (OS) | Reported at 1 and 2 years after the start of treatment | Survival is defined as the duration of time from start of treatment to time of death, up to three years from the start of study treatment. Overall Survival (OS) is reported below as the proportion of patients who are alive at 1 and 2 years after starting treatment. |
| Secondary | Duration of Response, Defined Per Cheson Criteria | Assessed from start of therapy for up to 3 years | The duration of overall response is measured from the time measurement criteria are met for Complete Remission or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. |
| Secondary | Delay to Cytotoxic Chemotherapy | Up to 1 year | Time to first cytotoxic chemotherapy is defined as the time (in months) from start of study treatment to time of first dose of anti-neoplastic cytotoxic chemotherapy that is administered to treat lymphoma. |
| Other | NM PET/CT vs. CT Imaging in PTCL | Up to 3 years | To evaluate the use of NM PET/CT vs CT imaging in PTCL, a review of the utilized imaging modalities during treatment as a tool of response assessment will be done. When both imaging modalities are chosen for a patient, response assessment will be compared. |
| Other | Validate a New Prognostic Model for Newly Diagnosed PTCL | Up to 3 years | Clinical biomarkers including age, race, histology, and stage as an assessment of prognosis. A points based system will be used to correlate with recently developed prognostic model. |
| Other | Immunohistochemistry Profile | Baseline | To investigate the tumor immunohistochemical profile to identify potential biomarkers associated with prognosis and treatment response. Archived tissue samples collected at baseline will be evaluated in order to determine how marker expression correlates with clinical outcome. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR), as Defined Per Cheson Criteria | Assessed after cycles 3 and 6, then every 6 months up to 3 years | participants | NUMBER | |
| SECONDARY | Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Evaluated once per cycle (1 cycle=28 days) up to 1 year. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) | Reported at 1 and 3 years after the start of treatment | PFS Probability | NUMBER | |
| SECONDARY | Overall Survival (OS) | Reported at 1 and 2 years after the start of treatment | OS Probablilty | NUMBER | |
| SECONDARY | Duration of Response, Defined Per Cheson Criteria | Assessed from start of therapy for up to 3 years | Days | MEDIAN | |
| SECONDARY | Delay to Cytotoxic Chemotherapy | Up to 1 year | This endpoint was not analyzed. No data was collected to analyze this endpoint. | ||
| OTHER_PRE_SPECIFIED | NM PET/CT vs. CT Imaging in PTCL | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Validate a New Prognostic Model for Newly Diagnosed PTCL | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Immunohistochemistry Profile | Baseline |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR), as Defined Per Cheson Criteria | Treatment (Romidepsin, Lenalidomide) | Complete Response (CR) | 6 | participants | |
| Objective Response Rate (ORR), as Defined Per Cheson Criteria | Treatment (Romidepsin, Lenalidomide) | Partial Response (PR) | 9 | participants | |
| Objective Response Rate (ORR), as Defined Per Cheson Criteria | Treatment (Romidepsin, Lenalidomide) | Stable Disease (SD) | 2 | participants | |
| Objective Response Rate (ORR), as Defined Per Cheson Criteria | Treatment (Romidepsin, Lenalidomide) | Progressive Disease (PD) | 6 | participants | |
| Objective Response Rate (ORR), as Defined Per Cheson Criteria | Treatment (Romidepsin, Lenalidomide) | CR + PR | 15 | participants | |
| Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Romidepsin, Lenalidomide) | Thrombocytopenia | 10 | Participants | |
| Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Romidepsin, Lenalidomide) | Anemia | 8 | Participants | |
| Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Romidepsin, Lenalidomide) | Lung Infection | 3 | Participants | |
| Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Romidepsin, Lenalidomide) | Sepsis | 3 | Participants | |
| Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Romidepsin, Lenalidomide) | Hypoalbuminemia | 7 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Treatment Period: Cycles 1-3 | STARTED | Treatment (Romidepsin, Lenalidomide) | 30 | |
| Study Treatment Period: Cycles 1-3 | Cycle 1 | Treatment (Romidepsin, Lenalidomide) | 29 | |
| Study Treatment Period: Cycles 1-3 | Cycle 2 | Treatment (Romidepsin, Lenalidomide) | 23 | |
| Study Treatment Period: Cycles 1-3 | Cycle 3 | Treatment (Romidepsin, Lenalidomide) | 20 | |
| Study Treatment Period: Cycles 1-3 | 1st Response Assessment | Treatment (Romidepsin, Lenalidomide) | 23 | |
| Study Treatment Period: Cycles 1-3 | COMPLETED | Treatment (Romidepsin, Lenalidomide) | 20 | |
| Study Treatment Period: Cycles 1-3 | NOT COMPLETED | Treatment (Romidepsin, Lenalidomide) | 10 | |
| Study Treatment Period: Cycles 4-6 | STARTED | Treatment (Romidepsin, Lenalidomide) | 20 | |
| Study Treatment Period: Cycles 4-6 | Cycle 4 | Treatment (Romidepsin, Lenalidomide) | 15 | |
| Study Treatment Period: Cycles 4-6 | Cycle 5 | Treatment (Romidepsin, Lenalidomide) | 13 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events196
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 | Treatment (Romidepsin, Lenalidomide) | 26 | 29 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Treatment (Romidepsin, Lenalidomide) | 3 | 29 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Treatment (Romidepsin, Lenalidomide) | 1 | 29 | |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Treatment (Romidepsin, Lenalidomide) | 1 | 29 | |
| other | Atrial fibrillation | Cardiac disorders | Treatment (Romidepsin, Lenalidomide) | 1 | 29 | |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Treatment (Romidepsin, Lenalidomide) | 1 | 29 | |
| other | Palpitations | Cardiac disorders | Treatment (Romidepsin, Lenalidomide) | 1 | 29 | |
| other | Sinus bradycardia | Cardiac disorders | Treatment (Romidepsin, Lenalidomide) | 3 | 29 | |
| other | Sinus tachycardia | Cardiac disorders | Treatment (Romidepsin, Lenalidomide) | 8 | 29 | |
| other | Ventricular arrhythmia | Cardiac disorders | Treatment (Romidepsin, Lenalidomide) | 1 | 29 |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Romidepsin, Lenalidomide) | 15 | 29 |
| Total, other adverse events | Treatment (Romidepsin, Lenalidomide) | 29 | 29 |
| Total, serious adverse events | Treatment (Romidepsin, Lenalidomide) | 23 | 29 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37327113 | 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 |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 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.
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