Trial · NCT02561273
Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma
NCT02561273, Phase 1, Phase 2, Completed, University of Nebraska; results first posted 2021-06-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma. Trials, record NCT02561273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02561273
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma
- NCT number
- NCT02561273
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- University of Nebraska
- Conditions
Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Hepatosplenic T-Cell Lymphoma, Peripheral T-Cell Lymphoma, Not Otherwise Specified, Stage II Angioimmunoblastic T-cell Lymphoma, Stage II Enteropathy-Associated T-Cell Lymphoma, Stage III Angioimmunoblastic T-cell Lymphoma, Stage III Enteropathy-Associated T-Cell Lymphoma, Stage IV Angioimmunoblastic T-cell Lymphoma, Stage IV Enteropathy-Associated T-Cell Lymphoma
- Interventions
Autologous Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, Laboratory Biomarker Analysis, Lenalidomide, Peripheral Blood Stem Cell Transplantation, Prednisone, Vincristine Sulfate
- First posted
- 2015-09-28
- Last updated
- 2023-12-13
- Results first posted
- 2021-06-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP | 21 days | MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I) within the first cycle of study treatment. |
| Primary | Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) | Up to 6 cycles of treatment (approximately 5 months) | Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized. |
| Primary | Complete Response Rate (Phase II) | Up to the completion of course 6 (18 weeks) | A success is defined to be an objective status of CR after completion of 6 cycles of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A 95% confidence interval for the true overall CR rate will be calculated according to the method of Duffy and Santner. |
| Primary | Overall Response Rate | Up to the completion of course 6 (18 weeks) | The ORR will be estimated by the total number of patients who achieve a PR or CR at the end of six cycles of treatment divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true ORR will be calculated. |
| Secondary | Number of Participants With Adverse Events Graded According to CTC (Phase II) | Up to 1 year | The toxicity profile will be further assessed based on phase II patients. Overall toxicity incidence of maximum tolerated dose level of the Intent to treat (ITT) group of subjects is summarized. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group. |
| Secondary | Overall Survival | Time from registration to death due to any cause, assessed up to 1 year | The distribution of overall survival will be estimated using the method of Kaplan-Meier. |
| Secondary | Progression-free Survival | Time from registration to progression or death due to any cause, assessed up to 2 years | The distribution of PFS will be estimated using the method of Kaplan-Meier. The PFS rate at 2 years will be estimated. A 2-year PFS rate of 60% will be considered of interest. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP | 21 days | Eight subjects were dosed at 10 mg dose and 4 subjects were dosed at 15 mg dose. | milligrams | NUMBER |
| PRIMARY | Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) | Up to 6 cycles of treatment (approximately 5 months) | Toxicity was measured for all subjects dosed during Phase 1 of the study. 10 mg and 15 mg dose levels. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Complete Response Rate (Phase II) | Up to the completion of course 6 (18 weeks) | Assessment based on phase II patients given the maximum tolerated dose level (10 mg) as the Intent to treat (ITT) group of subjects. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group. | percentage of participants | NUMBER |
| PRIMARY | Overall Response Rate | Up to the completion of course 6 (18 weeks) | Assessment based on phase II patients given the maximum tolerated dose level (10 mg) as the Intent to treat (ITT) group of subjects. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events Graded According to CTC (Phase II) | Up to 1 year | Safety data for the Intent to treat (ITT) group of subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Time from registration to death due to any cause, assessed up to 1 year | Assessment based on phase II patients given the maximum tolerated dose level (10 mg) as the Intent to treat (ITT) group of subjects. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival | Time from registration to progression or death due to any cause, assessed up to 2 years | Assessment based on phase II patients given the maximum tolerated dose level (10 mg) as the Intent to treat (ITT) group of subjects. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP | Treatment (Combination Chemotherapy, Lenalidomide) | 10 | milligrams | ||
| Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) | 10 mg Lenalidomide Participants | grade 3,4 neutropenia | 5 | Participants | |
| Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) | 15 mg Lenalidomide Participants | grade 3,4 neutropenia | 4 | Participants | |
| Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) | 10 mg Lenalidomide Participants | grade 3, 4 anemia | 3 | Participants | |
| Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) | 15 mg Lenalidomide Participants | grade 3, 4 anemia | 3 | Participants | |
| Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) | 10 mg Lenalidomide Participants | grade 3, 4 thrombocytopenia | 2 | Participants | |
| Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) | 15 mg Lenalidomide Participants | grade 3, 4 thrombocytopenia | 3 | Participants | |
| Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) | 10 mg Lenalidomide Participants | grade 3,4 neutropenia fever | 4 | Participants | |
| Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) | 15 mg Lenalidomide Participants | grade 3,4 neutropenia fever | 0 | Participants | |
| Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) | 10 mg Lenalidomide Participants | grade 3, 4 diarrhea | 0 | Participants |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 10 mg Lenalidomide Participants | 40 | |
| Overall Study | STARTED | 15 mg Lenalidomide Participants | 4 | |
| Overall Study | COMPLETED | 10 mg Lenalidomide Participants | 39 | |
| Overall Study | COMPLETED | 15 mg Lenalidomide Participants | 4 | |
| Overall Study | NOT COMPLETED | 10 mg Lenalidomide Participants | 1 | |
| Overall Study | NOT COMPLETED | 15 mg Lenalidomide Participants | 0 |
Source ClinicalTrials.gov
Adverse events216
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 | Fatigue | General disorders | Treatment (10 mg Lenalidomide) | 32 | 39 | |
| other | Fatigue | General disorders | Treatment (15 mg Lenalidomide) | 4 | 4 | |
| other | White blood cell decreased | Investigations | Treatment (10 mg Lenalidomide) | 26 | 39 | |
| other | White blood cell decreased | Investigations | Treatment (15 mg Lenalidomide) | 3 | 4 | |
| other | Neutrophil count decreased | Investigations | Treatment (10 mg Lenalidomide) | 25 | 39 | |
| other | Neutrophil count decreased | Investigations | Treatment (15 mg Lenalidomide) | 4 | 4 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Treatment (10 mg Lenalidomide) | 23 | 39 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Treatment (15 mg Lenalidomide) | 2 | 4 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (10 mg Lenalidomide) | 23 | 39 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (15 mg Lenalidomide) | 3 | 4 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (10 mg Lenalidomide) | 9 | 39 |
| Total, all-cause mortality | Treatment (15 mg Lenalidomide) | 1 | 4 |
| Total, other adverse events | Treatment (10 mg Lenalidomide) | 32 | 39 |
| Total, other adverse events | Treatment (15 mg Lenalidomide) | 4 | 4 |
| Total, serious adverse events | Treatment (10 mg Lenalidomide) | 14 | 39 |
| Total, serious adverse events | Treatment (15 mg Lenalidomide) | 2 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA036727 | Buffett Cancer Center Support Grant | SWEASY, JOANN B. | UNIVERSITY OF NEBRASKA MEDICAL CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment (10 mg Lenalidomide) vs Treatment (15 mg Lenalidomide): deaths from any cause | Trial comparisons |
| Treatment (10 mg Lenalidomide) vs Treatment (15 mg Lenalidomide): serious adverse events | Trial comparisons |
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/NCT02561273
GET https://conductscience.org/api/trials/v1/NCT02561273/results?page=2