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Report for Clinical Trial NCT00931762

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Trial of Oral Panobinostat (LBH589), a Novel Deacetylase Inhibitor (DACi) in Patients With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia (ET) Myelofibrosis and Post- Polycythemia Vera (PV) Myelofibrosis

This study will assess the safety and efficacy of Panobinostat as a single agent in the treatment of Primary Myelofibrosis, Post-Polycythemia Vera and Post-Essential Thrombocythemia. There will be two cohorts - patients with JAK2 mutation and patients without JAK2 mutation.

NCT00931762 Primary Myelofibrosis Post-Polycythemia Vera Post-Essential Thrombocytopenia
MeSH:Polycythemia Vera Thrombocytopenia Primary Myelofibrosis Polycythemia
HPO:Polycythemia Thrombocytopenia

1 Interventions

Name: Panobinostat

Description: Panobinostat will be administered orally once a day on Monday, Wednesday and Friday at a fixed dose of 40 mg. A cycle is defined as 28 days of treatment.
Type: Drug
Group Labels: 1

Panobinostat


Primary Outcomes

Measure: To evaluate the overall response (CR, PR, and clinical improvement) to oral panobinostat as a single agent at 40 mg daily every Monday, Wednesday and Friday in patients with myelofibrosis.

Time: Upon enrollment of 13 participants into each cohort of the study and at the end of the study.

Secondary Outcomes

Measure: To compare the response to panobinostat in patients with the JAK2 V617F mutation to those without the JAK2 V617F mutation

Time: Upon enrollment of 13 participants into the study and at the end of the study

Measure: To evaluate the symptomatic improvement of myelofibrosis patients treated with panobinostat using the Myelofibrosis Symptom Assessment Form (MF-SAF) at baseline and after 2 and 4 months of treatment

Time: Upon enrollment of 13 participants in each cohort and at the end of the study

Measure: To evaluate the symptomatic improvement of myelofibrosis patients treated with panobinostat using the Myelofibrosis Symptom Assessment Form (MF-SAF) at baseline and after 2 and 4 months of treatment

Time: throughout the study

Measure: To assess compliance to panobinostat treatment as assessed by monthly capsule counts

Time: at the end of the study

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V617F

To compare the response to panobinostat in patients with the JAK2 V617F mutation to those without the JAK2 V617F mutation. --- V617F ---

To compare the response to panobinostat in patients with the JAK2 V617F mutation to those without the JAK2 V617F mutation. --- V617F --- --- V617F ---

(The presence of a JAK2 V617F mutation is not required for study entry) 2. Patients must meet the following laboratory criteria: - Patients can be either JAK2 V617F mutated or wild type - Serum potassium, magnesium, phosphorous, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution Note: Potassium, magnesium, phosphorous, sodium, and/or calcium supplements maybe given to correct values that are < LLN. --- V617F ---

(The presence of a JAK2 V617F mutation is not required for study entry) 2. Patients must meet the following laboratory criteria: - Patients can be either JAK2 V617F mutated or wild type - Serum potassium, magnesium, phosphorous, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution Note: Potassium, magnesium, phosphorous, sodium, and/or calcium supplements maybe given to correct values that are < LLN. --- V617F --- --- V617F ---



HPO Nodes


HPO:
HP:0001873: Thrombocytopenia
Genes 412
CTC1 TBXAS1 RNASEH2C SRP54 MYORG SLC20A2 TET2 MYH9 HLCS CD40LG ERCC6L2 XPR1 CFI IVD SCARB2 UBE2T MPL DOCK6 RBPJ VPS33A EFL1 FASLG STOX1 OCRL TINF2 FOXP3 PRKCD CR2 IRAK1 FCGR2C GBA ACTN1 TINF2 PSMB8 NHEJ1 IL7R TNFSF12 CFI TINF2 LAT NHP2 TBX1 DHFR TERT DNAJC21 VWF SAMHD1 G6PC3 MECOM UROS FASLG CORIN UFD1 GP9 SBDS NHP2 MYSM1 CD81 TNFSF12 CFH RNASEH2A LRBA ARHGEF1 DNAJC21 ITGA2B DCLRE1C XRCC2 HELLPAR NFKB2 NOP10 JMJD1C CD46 PALB2 RAG2 DGUOK FCGR2A WAS POMP KDM6A FANCE ABL1 NHP2 ICOS NFKB1 FCGR2B CA2 HLA-DRB1 FAS RAD51 MMAA STAT3 SEC24C STT3B C1R GBA AGK FANCD2 TET2 VWF RTEL1 ITGB3 ANKRD11 CDC42 TERT FANCC IFNG IRF2BP2 PEPD GUCY1A1 SPATA5 GBA ACD BCOR RUNX1 FLT1 COMT ACP5 GBA ERCC4 MVK CFB SBDS WAS NFKB1 NFKB2 GBA GP1BB MMACHC CDC42 MAP2K1 GATA1 BRCA1 PARN STIM1 RFWD3 KIF15 PCCA PSMB4 DNASE1 TET2 BRAF GATA2 ABCA1 ZBTB16 NUMA1 TINF2 DKC1 ITGB3 UROS TREX1 SALL4 HYOU1 STAT5B GBA MMUT C1QA RAG2 TERC MMUT JAK2 FANCB RREB1 FANCA MPL HOXA11 SLC35A1 ELANE FANCC CD46 SLFN14 MAD2L2 KRAS FOXP3 RUNX1 MMUT CD19 SARS2 SBDS WRAP53 ACAD9 GP1BB EFL1 GFI1B NABP1 TREX1 FARS2 SLC19A2 WIPF1 TERC DKC1 NSUN2 ETV6 NBN USP18 PTPN11 WAS STAT3 SP110 SRC PRF1 EOGT RARA SALL4 HLCS C3 CD109 MYH9 TERT TNFAIP3 MECOM PRF1 SC5D ITGA2 ITK SMPD1 PRKCD ABCD4 FLI1 ATRX NOS3 GATA1 NPM1 TPP2 COL4A5 ANKRD26 MTOR TCN2 TUBB1 PRDX1 WFS1 NRAS PRKAR1A OSTM1 SLC46A1 DGKE FIP1L1 MYSM1 HPS5 UBE2T RNASEH2B PML TBL1XR1 SRP54 SMARCAL1 GNA14 ACAD9 FANCE ESCO2 FANCL RFX5 ATP7B OCLN IFIH1 JAK2 MPIG6B HIRA PSAP LIG4 PHGDH SLC35A1 TERC FANCG SF3B1 KMT2D BRIP1 SLC19A2 ADAMTS13 BCR GATA1 NBN FANCF PSMB9 ALG8 GP9 CD36 TALDO1 FAS PDGFB CLCN7 PCCB CD81 NOTCH1 STIM1 ADAR LMBRD1 STAT1 FYB1 PARN TMEM165 RFXANK TNFRSF13C TNFRSF13B STX11 GALC CALR PNP USB1 CIITA RFXAP ADA FLNA COG1 BTK FANCA NBEAL2 CASP10 FANCM RTEL1 SLC46A1 TNFSF11 ARHGAP31 RBM8A ITGA2B CTLA4 SLC7A7 GFI1B RBM8A COG4 LBR PDGFRB RAG1 SAMD9L RAG1 FANCD2 GBA TFRC RASGRP1 CASP10 GP1BB BRCA2 PNP DLL4 TNFRSF11A STAT4 RAD51C HLA-B ARVCF SH2D1A SMARCD2 LARS2 ZAP70 PTPN22 SMARCAL1 RNASEH2C TREX1 SAMD9 BTNL2 APOE SLX4 NPM1 GATA1 COG6 IKZF1 SLC7A7 DKC1 ARPC1B MS4A1 VPS45 CFHR1 RPS19 PLAU TBX1 PRKCD BLOC1S6 GATA1 FANCG APOE FANCI LYST SAMHD1 TET2 STT3B LIG4 SCARB2 CFHR3 DIAPH1 LYST SNX10 RNASEH2A FLI1 CTLA4 FANCB GP1BB TERT GATA1 PRKACG XIAP SPP1 NBEAL2 CTC1 NOP10 GP1BA MMAB GP1BA FAS CFH VPS33A HOXA11 TALDO1 NIPBL GP1BA MPL MAD2L2 CYCS AP3B1 IFIH1 GP1BA THBD SPATA5 TERT ERBB3 WIPF1
Protein Mutations 2
G20210A V617F
SNP 0