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Report for Clinical Trial NCT00931762
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
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
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
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:Polycythemia
Genes 19
EPO CCND1 ACVRL1 GATA1 VHL EPAS1 EGLN1 FH SLC30A10 SLC30A10 CYB5R3 SH2B3 PKLR JAK2 JAK2 EPOR BPGM ENG VHL hr>Thrombocytopenia
Genes 409
ERCC6L2 TNFRSF11A MECOM SBDS NIPBL ARPC1B NFKB1 CTC1 JAK2 CASP10 TET2 ATRX TREX1 RFX5 TERT SF3B1 SBDS RASGRP1 NOP10 HYOU1 PRKCD MECOM IRF2BP2 FANCG PEPD TERC ERCC4 WAS PARN GBA TREX1 GUCY1A1 FANCF TNFAIP3 TINF2 NRAS LARS2 RFXAP MMAB IFIH1 ALG8 SLC7A7 HIRA SLC19A2 GP1BA DIAPH1 GP1BA RNASEH2C ANKRD26 TBL1XR1 DHFR FIP1L1 PRF1 HLCS SAMD9 SMPD1 CIITA RBPJ BCOR NPM1 ITK BCR JAK2 SRP54 IFIH1 XPR1 PLAU STX11 SLC46A1 DNASE1 ARVCF NABP1 CALR RAG2 GALC TNFRSF13C SEC24C CFH FANCG ITGA2 FCGR2A COG6 PHGDH TCN2 RUNX1 NUMA1 IFNG GATA1 FLI1 ELANE JMJD1C COMT CA2 HPS5 STAT3 KRAS TUBB1 ATP7B SLC7A7 ITGA2B GFI1B MYSM1 SLC20A2 CORIN VWF MPL FANCA GP1BB POMP GATA1 NHEJ1 TPP2 GBA GBA LRBA FANCB EFL1 RAD51 PRKACG PDGFB C1R MMUT GP1BB RUNX1 FANCD2 USP18 WIPF1 CD81 NOS3 ACAD9 AP3B1 PRF1 GATA2 FANCB FLI1 ADAMTS13 BRCA1 MAP2K1 RTEL1 APOE ITGA2B SPP1 CTLA4 GATA1 BRAF IL7R NPM1 ARHGEF1 MTOR XRCC2 MPL FOXP3 DCLRE1C PSMB8 PSMB4 SP110 FANCC COG4 ACTN1 SLC46A1 FANCL MYORG RREB1 C1QA ESCO2 WRAP53 RNASEH2A BTK DGKE DNAJC21 FAS TINF2 LIG4 ITGB3 CD81 FCGR2C DKC1 OSTM1 PRKCD SAMD9L GP1BA BTNL2 PTPN11 SPATA5 TNFSF12 FLT1 DLL4 ZBTB16 FASLG STIM1 RAD51C STAT5B C3 NHP2 GATA1 PRDX1 G6PC3 GP1BB ARHGAP31 GP1BA SLC35A1 MS4A1 NBEAL2 FASLG ACAD9 NFKB2 FANCD2 KIF15 APOE STOX1 RFWD3 STT3B TERT UROS WIPF1 NOP10 LMBRD1 GBA HLA-B LBR TNFSF11 SLC19A2 NHP2 VWF HOXA11 TBX1 PTPN22 STAT4 PML SCARB2 FANCI GP9 CFB LAT ERBB3 SALL4 PARN NBN TET2 ITGA2 RARA GFI1B MAD2L2 HELLPAR ICOS RFXANK GATA1 TNFSF12 USB1 CFH FAS SMARCAL1 SBDS LYST HOXA11 FANCA STAT1 PCCB SLC35A1 TALDO1 ANKRD11 SLX4 CASP10 TET2 RAG2 TERT AGK CYCS ACD TNFRSF13B GP9 KDM6A FYB1 RNASEH2A DNAJC21 SMARCAL1 VPS45 KMT2D GBA PALB2 CFI TALDO1 ABL1 HLCS CD46 FANCE FANCM FLNA CFI WFS1 LIG4 SNX10 SLFN14 PDGFRB DKC1 PNP STT3B COG1 CR2 ADA TMEM165 FARS2 ZAP70 UFD1 ETV6 STAT3 NBN GBA CFHR1 CD19 SALL4 ABCD4 TREX1 PSMB9 GP1BB RBM8A TERC RAG1 TFRC EFL1 OCLN FOXP3 FANCE CLCN7 CTC1 LYST TBXAS1 NOTCH1 MMAA DOCK6 MPL FAS TERT NSUN2 CTLA4 XIAP ITGB3 COL4A5 VPS33A PRKAR1A FCGR2B RAG1 THBD WAS TERC GNA14 BLOC1S6 RNASEH2B CFHR3 RPS19 SC5D BRCA2 WAS HLA-DRB1 IKZF1 PRKCD ACP5 MYH9 UBE2T SH2D1A TINF2 MVK EOGT CDC42 CD109 MPIG6B SCARB2 OCRL ADAR RNASEH2C SMARCD2 MYH9 CD36 NHP2 CD40LG CD46 TINF2 SRP54 FCGR2C DKC1 GATA1 PSAP NBEAL2 SAMHD1 IRAK1 DGUOK MAD2L2 MMUT NFKB1 FANCC SRC UROS BRIP1 ABCA1 SARS2 PCCA GBA MMACHC TBX1 IVD TET2 MMUT STIM1 UBE2T RTEL1 TERT SAMHD1 RBM8A NFKB2 hr>