SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02425904

Developed by Shray Alag, 2019.
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 Histiocytosis, Langerhans-Cell
HPO: Histiocytosis

1 Interventions

Name: Clofarabine

Description: Evaluation of response to clofarabine

Type: Drug

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

SNPs


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


HPO:
Histiocytosis
Genes 2
IFNGR1 SLC29A3