Trial · NCT02425904
Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders
NCT02425904, Phase 2, Active not recruiting, Dana-Farber Cancer Institute; results first posted 2022-02-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders. Trials, record NCT02425904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02425904
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders
- NCT number
- NCT02425904
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Langerhans Cell Histiocytosis
- Interventions
- Clofarabine
- First posted
- 2015-04-24
- Last updated
- 2026-06-23
- Results first posted
- 2022-02-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (OR) of LCH Cohort | Disease was evaluated at baseline and the end of cycle 2. Treatment continued after cycle 2 until disease progression or unacceptable toxicity. LCH treatment duration has a median of 5.8 months with range 2.1-7 months. | The OR was defined as the proportion of participants achieving certain response on treatment among LCH patients, criteria were defined per protocol. Better response were defined as achieving complete disease resolution (NAD) or disease regression (AD better); intermediate response defined as stable or unchanged disease status; worse response defined as disease progression. |
| Primary | Response Rate of LCH-related Disorders Cohort | Disease was evaluated at baseline and the end of cycle 2. Treatment continued after cycle 2 until disease progression or unacceptable toxicity. Treatment duration has a median of 5.5 months with range 1.7-5.6 months. | The OR was defined as the proportion of participants achieving certain response on treatment among LCH-related disorder patients, criteria were defined per protocol. A clinical response of progressive metabolic disease (PMD) defined as CT-based target lesion abnormal and bone marrow new or recurrent involvement; partial metabolic response (PMR) defined as CT-based target lesion decreasing or disease regressed. |
| Secondary | 1-year Progression Free Survival (PFS) | At 1 year | 1-year PFS defined as the proportion of patients that survival progression free at 1 year. PFS based on the duration of time from study entry to documented disease progression (PD) or death. Per protocol criteria: where time to event for PFS is the time from study enrollment until the time of first occurrence of new lesions, progressive disease, or death from any cause, or until last contact if no event occurs. |
| Secondary | 1-year Overall Survival (OS) | At 1 year | 1-year OS defined as the proportion of patients that survival at 1 year. OS calculated as the time from enrollment until death or censored at date last known alive. |
| Secondary | Number of Participants With at Least One Grade 3 or Higher Treatment-Related Toxicity | Disease was evaluated at baseline and the end of cycle 2. Treatment continued after cycle 2 until disease progression or unacceptable toxicity. LCH treatment duration is median 5.8 with range 2.1-7 months; LCH-related treatment duration is 5.5 (1.7-5.6). | All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4.0 as reported on case report forms were counted. Number of Participants with at least one Grade 3 or Higher Treatment-Related Toxicity defined as number of patients experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate (OR) of LCH Cohort | Disease was evaluated at baseline and the end of cycle 2. Treatment continued after cycle 2 until disease progression or unacceptable toxicity. LCH treatment duration has a median of 5.8 months with range 2.1-7 months. | proportion of participants | NUMBER | |
| PRIMARY | Response Rate of LCH-related Disorders Cohort | Disease was evaluated at baseline and the end of cycle 2. Treatment continued after cycle 2 until disease progression or unacceptable toxicity. Treatment duration has a median of 5.5 months with range 1.7-5.6 months. | 1 patient excluded because of problematic enrollment | proportion of participants | NUMBER |
| SECONDARY | 1-year Progression Free Survival (PFS) | At 1 year | proportion of patients | NUMBER | |
| SECONDARY | 1-year Overall Survival (OS) | At 1 year | proportion of patients | NUMBER | |
| SECONDARY | Number of Participants With at Least One Grade 3 or Higher Treatment-Related Toxicity | Disease was evaluated at baseline and the end of cycle 2. Treatment continued after cycle 2 until disease progression or unacceptable toxicity. LCH treatment duration is median 5.8 with range 2.1-7 months; LCH-related treatment duration is 5.5 (1.7-5.6). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (OR) of LCH Cohort | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | Better | 0.85 | 95% Confidence Interval 0.62 to 0.97 | proportion of participants |
| Response Rate (OR) of LCH Cohort | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | Intermediate | 0.15 | 95% Confidence Interval 0.03 to 0.38 | proportion of participants |
| Response Rate (OR) of LCH Cohort | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | Worse | 0 | 95% Confidence Interval 0 to 0 | proportion of participants |
| Response Rate of LCH-related Disorders Cohort | LCH-related Disorders + Clofarabine | PMR | 0.75 | 95% Confidence Interval 0.19 to 0.99 | proportion of participants |
| Response Rate of LCH-related Disorders Cohort | LCH-related Disorders + Clofarabine | PMD | 0.26 | 95% Confidence Interval 0.006 to 0.81 | proportion of participants |
| 1-year Progression Free Survival (PFS) | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 0.89 | proportion of patients | ||
| 1-year Progression Free Survival (PFS) | LCH-related Disorders + Clofarabine | 0.5 | proportion of patients | ||
| 1-year Overall Survival (OS) | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 1 | proportion of patients | ||
| 1-year Overall Survival (OS) | LCH-related Disorders + Clofarabine | 0.75 | proportion of patients | ||
| Number of Participants With at Least One Grade 3 or Higher Treatment-Related Toxicity | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 15 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 20 | |
| Overall Study | STARTED | LCH-related Disorders + Clofarabine | 5 | |
| Overall Study | Efficacy analysis | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 20 | |
| Overall Study | Efficacy analysis | LCH-related Disorders + Clofarabine | 4 | |
| Overall Study | COMPLETED | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 17 | |
| Overall Study | COMPLETED | LCH-related Disorders + Clofarabine | 2 | |
| Overall Study | NOT COMPLETED | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 3 | |
| Overall Study | NOT COMPLETED | LCH-related Disorders + Clofarabine | 3 |
Source ClinicalTrials.gov
Adverse events224
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 | Abdominal distension | Gastrointestinal disorders | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 1 | 20 | |
| other | Abdominal distension | Gastrointestinal disorders | LCH-related Disorders + Clofarabine | 0 | 0 | |
| other | Abdominal pain | Gastrointestinal disorders | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 4 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | LCH-related Disorders + Clofarabine | 1 | 4 | |
| other | Agitation | Psychiatric disorders | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 1 | 20 | |
| other | Agitation | Psychiatric disorders | LCH-related Disorders + Clofarabine | 0 | 0 | |
| other | Alanine aminotransferase increased | Investigations | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 0 | 0 | |
| other | Alanine aminotransferase increased | Investigations | LCH-related Disorders + Clofarabine | 1 | 4 | |
| other | Alkaline phosphatase increased | Investigations | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 0 | 0 | |
| other | Alkaline phosphatase increased | Investigations | LCH-related Disorders + Clofarabine | 1 | 4 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 0 | 20 |
| Total, all-cause mortality | LCH-related Disorders + Clofarabine | 3 | 4 |
| Total, other adverse events | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 20 | 20 |
| Total, other adverse events | LCH-related Disorders + Clofarabine | 4 | 4 |
| Total, serious adverse events | Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine | 15 | 20 |
| Total, serious adverse events | LCH-related Disorders + Clofarabine | 4 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42126265 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine vs LCH-related Disorders + Clofarabine: Number of Participants With at Least One Grade 3 or Higher Treatment-Related Toxicity | Trial comparisons |
| Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine vs LCH-related Disorders + Clofarabine: deaths from any cause | Trial comparisons |
| Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine vs LCH-related Disorders + Clofarabine: 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/NCT02425904
GET https://conductscience.org/api/trials/v1/NCT02425904/events?page=2