Trial · NCT03703375
Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma
NCT03703375, Phase 3, Completed, Celgene; results first posted 2024-07-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma. Trials, record NCT03703375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03703375
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma
- NCT number
- NCT03703375
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 93 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Lymphoma, T-Cell
- Interventions
- Azacitidine, Romidepsin, Gemcitabine
- First posted
- 2018-10-12
- Last updated
- 2026-06-12
- Results first posted
- 2024-07-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Based on Local Assessment | From randomization up to documented disease progression or death, whichever occurs first (up to approximately 15 months) | PFS is defined as the time from randomization into the study to the first observation of documented disease progression (local assessment using Lugano Response Criteria 2014) or death due to any cause, whichever occurs first. If a participant has not progressed or died, PFS will be censored at the time of last visit with adequate assessment. C2 censoring rules were used per US FDA guidance 2015. Progression will be determined as per Response criteria for lymphoma: Lugano classification. |
| Secondary | Overall Survival (OS) | From randomization up to the date of death or date last known alive (up to approximately 27 months) | Overall survival is defined as the time from the date of randomization to the date of death from any cause. OS was censored at the last date that the participant was known to be alive. |
| Secondary | Progression Free Survival (PFS) Based on IRC Assessment | From randomization up to documented disease progression or death, whichever occurs first (up to approximately 37 months) | PFS based on Independant Review Committee (IRC) is defined as the time from randomization into the study to the first observation of documented disease progression (reviewed assessment by IRC using Lugano Response Criteria 2014) or death due to any cause. If a patient has not progressed or died, PFS will be censored at the time of last visit with adequate assessment per FDA's guidance 2015 Table C2. Progression will be determined as per Response criteria for lymphoma: Lugano classification. |
| Secondary | Overall Response Rates (ORR) | Response rate will be measured after Cycle 3, after Cycle 6 (up to approximately 5.5 months) | Overall response rates are the percentage of complete response (CR) and partial response (PR) per local assessment. Assessment of response will be based on Lugano Response Criteria 2014 for the radiologic response (CT based), the metabolic response (PET-CT based) and the best response between radiologic and metabolic response. Measurements occurred after Cycle 3, after Cycle 6, and at permanent treatment discontinuation. PR is defined as Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size and ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites. CR is defined as target nodes/nodal masses regressed to ≤ 1.5 cm in LDi, no extralymphatic sites of disease, and Score 1, 2, or 3 with or without a residual mass on the 5 Point Scale. The Lugano 5-point scale is 1, no uptake above background; 2, uptake mediastinum; 3, uptake mediastinum but liver; 4, uptake moderately liver; 5, uptake markedly higher than liver and/or new lesions. |
| Secondary | Complete Response Rate (CRR) | Response rate will be measured after Cycle 3, after Cycle 6 (up to approximately 5.5 months) | Complete response rate is the percentage of CR (complete metabolic response or CT-based CR) per local assessment before receiving any subsequent anti-lymphoma therapy. Assessment will be based on Lugano Response Criteria 2014 for the radiologic response (CT based), the metabolic response (PET-CT based) and best response between radiologic and metabolic response. Measurements occurred after Cycle 3, Cycle 6, and treatment discontinuation. PR is defined as Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size and ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites. CR is defined as target nodes/nodal masses regressed to ≤ 1.5 cm in LDi, no extralymphatic sites of disease, and Score 1, 2, or 3 with or without a residual mass. The Lugano 5-point scale is 1, no uptake above background; 2, uptake mediastinum; 3, uptake mediastinum but liver; 4, uptake moderately liver; 5, uptake markedly higher than liver and/or new lesions. |
| Secondary | Duration of Response (DOR) | From randomization to the date of first documented disease progression, relapse (local assessment) or death from any cause (up to approximately 27 months) | Duration of response is defined as the time from attainment of complete response (CR) or partial response (PR) per local assessment to the date of first documented disease progression, relapse (local assessment) or death from any cause. Participants alive and free of progression will be censored at their last visit with adequate assessment.CR: complete metabolic response or computed tomography (CT)-based CR; PR: partial metabolic response or CT-based PR before subsequent anti-lymphoma therapy. |
| Secondary | Time to Response (TTR) | From randomization to the date of attainment of complete response (CR) or partial response (PR) until end of treatment (up to approximately 37 months) | Time to response is defined as the time from randomization to the date of attainment of complete response (CR) or partial response (PR) per local assessment until end of treatment. If a participant is not responder, time to response will be censored at the time of last visit with adequate assessment. CR: complete metabolic response or computed tomography (CT)-based CR; PR: partial metabolic response or CT-based PR before subsequent anti-lymphoma therapy. |
| Secondary | Progression Free Survival 2 (PFS2) on Local Assessment | From randomization to objective tumor progression on next-line treatment or death from any cause (up to approximately 27 months) | PFS2 based on local assessment is defined as the time from randomization to objective tumor progression on next-line treatment or death from any cause. Participants without next-line therapy who did not die and participants who did not relapse or not die after next-line therapy will be censored at the last adequate tumor assessment date. |
| Secondary | Mean Change in Minimal Important Differences (MIDs) of the EORTC QLQ-C30 Health-related Quality-of-Life Domain Scores | At baseline and on Day 1 of each cycle up to treatment discontinuation (up to approximately 27 months) | The minimal important difference (MID) is the size of difference in Quality-of-Life score that is considered relevant (i.e. warranting a change in treatment or examinations). The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQC30) subscale values are the lower threshold for MID over time, based on within-group mean change. QLQ-C30 has 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain), a global health status / quality of life (QoL) scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Each scale was scored on a range from 0 to 100. Higher scores represent a higher response level. Note that a high score for global health status or for a functional scale represents a high or healthy level of functioning, but a high score for a symptom scale/item represents a high level of symptomatology/problems. |
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 | Progression Free Survival (PFS) Based on Local Assessment | From randomization up to documented disease progression or death, whichever occurs first (up to approximately 15 months) | Intent-to-Treat (ITT) population: all participants having signed their informed consent and who are randomized into the trial, regardless of they received study treatment or not.~This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization up to the date of death or date last known alive (up to approximately 27 months) | Intent-to-Treat (ITT) population: all participants having signed their informed consent and who are randomized into the trial, regardless of they received study treatment or not.~This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Based on IRC Assessment | From randomization up to documented disease progression or death, whichever occurs first (up to approximately 37 months) | Intent-to-Treat (ITT) population: all participants having signed their informed consent and who are randomized into the trial, regardless of they received study treatment or not.~This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered. | Months | MEDIAN |
| SECONDARY | Overall Response Rates (ORR) | Response rate will be measured after Cycle 3, after Cycle 6 (up to approximately 5.5 months) | CR and PR responders in Intent-to-Treat population.~This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered. | Percentage of participants | NUMBER |
| SECONDARY | Complete Response Rate (CRR) | Response rate will be measured after Cycle 3, after Cycle 6 (up to approximately 5.5 months) | CR and PR responders in Intent-to-Treat population~This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From randomization to the date of first documented disease progression, relapse (local assessment) or death from any cause (up to approximately 27 months) | CR or PR responders in Intent-to-Treat population~This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered. | Percentage of participants | NUMBER |
| SECONDARY | Time to Response (TTR) | From randomization to the date of attainment of complete response (CR) or partial response (PR) until end of treatment (up to approximately 37 months) | CR and PR responders in Intent-to-Treat population~This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered. | Months | MEDIAN |
| SECONDARY | Progression Free Survival 2 (PFS2) on Local Assessment | From randomization to objective tumor progression on next-line treatment or death from any cause (up to approximately 27 months) | Intent-to-Treat (ITT) population: all participants having signed their informed consent and who are randomized into the trial, regardless of they received study treatment or not.~This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered. | Months | MEDIAN |
| SECONDARY | Mean Change in Minimal Important Differences (MIDs) of the EORTC QLQ-C30 Health-related Quality-of-Life Domain Scores | At baseline and on Day 1 of each cycle up to treatment discontinuation (up to approximately 27 months) |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) Based on Local Assessment | Oral Azacitidine | 5.6 | 95% Confidence Interval 2.66 to 7.26 | Months | |
| Progression Free Survival (PFS) Based on Local Assessment | Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) | 2.8 | 95% Confidence Interval 1.87 to 4.83 | Months | |
| Overall Survival (OS) | Oral Azacitidine | 18.4 | 95% Confidence Interval 12.88 to 31.47 | Months | |
| Overall Survival (OS) | Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) | 10.3 | 95% Confidence Interval 4.24 to 13.50 | Months | |
| Progression Free Survival (PFS) Based on IRC Assessment | Oral Azacitidine | 4.2 | 95% Confidence Interval 2.66 to 5.88 | Months | |
| Progression Free Survival (PFS) Based on IRC Assessment | Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) | 3.2 | 95% Confidence Interval 2.10 to 4.83 | Months | |
| Overall Response Rates (ORR) | Oral Azacitidine | Cycle 3 | 33.3 | 95% Confidence Interval 19.6 to 49.5 | Percentage of participants |
| Overall Response Rates (ORR) | Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) | Cycle 3 | 43.2 | 95% Confidence Interval 28.3 to 59.0 | Percentage of participants |
| Overall Response Rates (ORR) | Oral Azacitidine | Cycle 6 | 31.0 | 95% Confidence Interval 17.6 to 47.1 | Percentage of participants |
| Overall Response Rates (ORR) | Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) | Cycle 6 | 22.7 | 95% Confidence Interval 11.5 to 37.8 | Percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Randomization (Safety Run-In) | STARTED | Oral Azacitidine | 7 | |
| Pre-Randomization (Safety Run-In) | STARTED | Investigators Choice Therapy - Romidepsin | 0 | |
| Pre-Randomization (Safety Run-In) | STARTED | Investigators Choice Therapy - Bendamustine | 0 | |
| Pre-Randomization (Safety Run-In) | STARTED | Investigators Choice Therapy - Gemcitabine | 0 | |
| Pre-Randomization (Safety Run-In) | COMPLETED | Oral Azacitidine | 7 | |
| Pre-Randomization (Safety Run-In) | COMPLETED | Investigators Choice Therapy - Romidepsin | 0 | |
| Pre-Randomization (Safety Run-In) | COMPLETED | Investigators Choice Therapy - Bendamustine | 0 | |
| Pre-Randomization (Safety Run-In) | COMPLETED | Investigators Choice Therapy - Gemcitabine | 0 | |
| Pre-Randomization (Safety Run-In) | NOT COMPLETED | Oral Azacitidine | 0 | |
| Pre-Randomization (Safety Run-In) | NOT COMPLETED | Investigators Choice Therapy - Romidepsin | 0 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events1,168
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 | Anaemia | Blood and lymphatic system disorders | Oral Azacitidine: 200 mg | 3 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Oral Azacitidine: 300 mg | 10 | 34 | |
| other | Anaemia | Blood and lymphatic system disorders | Investigators Choice Therapy - Romidepsin | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Investigators Choice Therapy - Bendamustine | 2 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Investigators Choice Therapy - Gemcitabine: 1000 mg/m2 | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Investigators Choice Therapy - Gemcitabine: 1200 mg/m2 | 9 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Safety Run-in Oral Azacitidine: 100 mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Safety Run-in Oral Azacitidine: 200 mg | 1 | 3 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Oral Azacitidine: 200 mg | 0 | 8 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Oral Azacitidine: 300 mg | 0 | 34 |
1 to 10 of 1,168Source ClinicalTrials.gov
See all 1,168 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Azacitidine: 200 mg | 6 | 8 |
| Total, all-cause mortality | Oral Azacitidine: 300 mg | 20 | 34 |
| Total, all-cause mortality | Investigators Choice Therapy - Romidepsin | 1 | 4 |
| Total, all-cause mortality | Investigators Choice Therapy - Bendamustine | 13 | 16 |
| Total, all-cause mortality | Investigators Choice Therapy - Gemcitabine: 1000 mg/m2 | 3 | 3 |
| Total, all-cause mortality | Investigators Choice Therapy - Gemcitabine: 1200 mg/m2 | 14 | 21 |
| Total, all-cause mortality | Safety Run-in Oral Azacitidine: 100 mg | 1 | 4 |
| Total, all-cause mortality | Safety Run-in Oral Azacitidine: 200 mg | 2 | 3 |
| Total, other adverse events | Oral Azacitidine: 200 mg | 7 | 8 |
| Total, other adverse events | Oral Azacitidine: 300 mg | 33 | 34 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38796193 | DERIVED |
Source PubMed
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/NCT03703375
GET https://conductscience.org/api/trials/v1/NCT03703375/flow?page=2