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Report for Clinical Trial NCT02425904

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders

This research study is evaluating a drug called clofarabine as a possible treatment for Langerhans Cell Histiocytosis (LCH) and and other histiocytic disorders.

NCT02425904 Langerhans Cell Histiocytosis
MeSH:Histiocytosis, Langerhans-Cell Histiocytosis

1 Interventions

Name: Clofarabine

Description: Evaluation of response to clofarabine
Type: Drug
Group Labels: 2

1-Recurrent or Refractory LCH 2-LCH-related disorders

Primary Outcomes

Description: Responses will be assessed using the standard criteria proposed by the Histiocyte Society

Measure: Overall Response Rate

Time: Week 7

Secondary Outcomes

Measure: Progression Free Survival

Time: At three and five years

Measure: Overall Survival

Time: At three and five years

Measure: The proportion of patients who experience a toxicity-event requiring stopping clofarabine

Time: Baseline, Up to 24 weeks

Measure: Proportion of participants with grade 3-4 toxicity

Time: Baseline, Up to 24 Weeks

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment

There is one SNP


1 V600E

ECD patients who have confirmed BRAF V600E mutation must have failed treatment with a BRAF inhibitor or are not considered to be eligible for such treatment. --- V600E ---

HPO Nodes