Trial · NCT02523040
Lenalidomide for Adult Histiocyte Disorders
NCT02523040, Phase 2, Active not recruiting, Dana-Farber Cancer Institute; results first posted 2025-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lenalidomide for Adult Histiocyte Disorders. Trials, record NCT02523040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02523040
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenalidomide for Adult Histiocyte Disorders
- NCT number
- NCT02523040
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Langerhans Cell Histiocytosis (LCH), Histiocytoses Erdheim-chester Disease, Histiocytic Sarcoma (HS)
- Interventions
- Lenalidomide
- First posted
- 2015-08-14
- Last updated
- 2026-07-23
- Results first posted
- 2025-04-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Disease assessed every 3 cycles on treatment up do 12 cycles (approximately 12 months). | Proportion of participants achieving either complete resolution of all signs or symptoms which is non-active disease (NAD) status or regression of signs or symptoms along with no new lesions which is better active-disease (AD) status per Histiocyte Society criteria any time on treatment. |
| Secondary | 12-months Progression-free Survival (PFS) | Disease assessed on treatment every 3 cycles and in long-term follow-up up to the earlier of 36 months (every 3 months for 2 years then every 6 months) or start of new anti-cancer therapy. Relevant for this endpoint was12-months estimate. | Progression-free survival (PFS) based on the Kaplan-Meier method is defined as time from registration to progression (PD) or death, censored for patients alive and progression-free at last disease assessment. PD is defined by Histiocyte criteria. Percent PFS is the percent of patients who are alive and progression-free at 12 months. |
| Secondary | 12-months Overall Survival (OS) | 12 Months | Overall survival (OS) based on the Kaplan-Meier method is defined as the time from registration to death, censored for patients alive at last contact. Percent OS is the percent of patients who are alive at 12 months. |
| Secondary | Incidence of Grade 3-4 Toxicity | Up to 12 months on treatment. | Grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite (treatment-related) based on NCI Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) as reported on case report forms were tabulated by maximum grade. Incidence is the proportion of participants experiencing at least one treatment-related grade 3-4 AE of any type during the time of observation. |
| Secondary | Urine Cell Free DNA for BRAF | 12 Months | Quantitative serial measurements of urine cell free DNA for BRAF mutation as a biomarker of response |
| Secondary | Percent Change in Serum TNF-alpha Levels on Therapy From Baseline up to 12 Cycles | Measured at baseline, day 1 of cycles 3, 6 ad 12 cycles and within 28 days post-treatment end (up to 13 months). | Serum TNF-alpha levels were quantified per established methods and maximum percent change in level from baseline derived. |
| Secondary | Plasma Cell Free DNA for BRAF | 12 months | Quantitative serial measurements of plasma cell free DNA for BRAF mutation as a biomarker of response |
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 | Overall Response Rate (ORR) | Disease assessed every 3 cycles on treatment up do 12 cycles (approximately 12 months). | proportion of participants | NUMBER | |
| SECONDARY | 12-months Progression-free Survival (PFS) | Disease assessed on treatment every 3 cycles and in long-term follow-up up to the earlier of 36 months (every 3 months for 2 years then every 6 months) or start of new anti-cancer therapy. Relevant for this endpoint was12-months estimate. | percentage probability | NUMBER | |
| SECONDARY | 12-months Overall Survival (OS) | 12 Months | Survival followed up 36 months from start of protocol treatment. Relevant for this endpoint was12-months estimate. | percentage probability | NUMBER |
| SECONDARY | Incidence of Grade 3-4 Toxicity | Up to 12 months on treatment. | proportion of participants | NUMBER | |
| SECONDARY | Urine Cell Free DNA for BRAF | 12 Months | |||
| SECONDARY | Percent Change in Serum TNF-alpha Levels on Therapy From Baseline up to 12 Cycles | Measured at baseline, day 1 of cycles 3, 6 ad 12 cycles and within 28 days post-treatment end (up to 13 months). | Participants with baseline and at least one on-treatment cycle TNF-alpha measurement. | percent change from baseline | MEDIAN |
| SECONDARY | Plasma Cell Free DNA for BRAF | 12 months |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Lenalidomide | 0.67 | 90% Confidence Interval 0.39 to 0.88 | proportion of participants | |
| 12-months Progression-free Survival (PFS) | Lenalidomide | 62 | 95% Confidence Interval 39 to 100 | percentage probability | |
| 12-months Overall Survival (OS) | Lenalidomide | 92 | 95% Confidence Interval 77 to 100 | percentage probability | |
| Incidence of Grade 3-4 Toxicity | Lenalidomide | 0.25 | 90% Confidence Interval 0.07 to 0.53 | proportion of participants | |
| Percent Change in Serum TNF-alpha Levels on Therapy From Baseline up to 12 Cycles | Lenalidomide | -14.4 | Full Range -67.3 to 8.3 | percent change from baseline |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenalidomide | 12 | |
| Overall Study | Evaluable for TNF-Alpha Evaluable for TNF Alpha | Lenalidomide | 6 | |
| Overall Study | COMPLETED | Lenalidomide | 12 | |
| Overall Study | NOT COMPLETED | Lenalidomide | 0 |
Source ClinicalTrials.gov
Adverse events70
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 | Lenalidomide | 10 | 12 | 12 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Lenalidomide | 9 | 12 | 19 |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Lenalidomide | 6 | 12 | 7 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Lenalidomide | 5 | 12 | 5 |
| other | Neutrophil count decreased | Investigations | Lenalidomide | 5 | 12 | 16 |
| other | Anemia | Blood and lymphatic system disorders | Lenalidomide | 4 | 12 | 6 |
| other | Constipation | Gastrointestinal disorders | Lenalidomide | 4 | 12 | 4 |
| other | Diarrhea | Gastrointestinal disorders | Lenalidomide | 4 | 12 | 5 |
| other | Headache | Nervous system disorders | Lenalidomide | 4 | 12 | 4 |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Lenalidomide | 4 | 12 | 4 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenalidomide | 1 | 12 |
| Total, other adverse events | Lenalidomide | 11 | 12 |
| Total, serious adverse events | Lenalidomide | 5 | 12 |
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/NCT02523040
GET https://conductscience.org/api/trials/v1/NCT02523040/events?page=2