SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03355768

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Randomized Study of Romidepsin Versus the Combination of Romidepsin Plus Pralatrexate in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

This study employs a 1:1 randomization of patients to receive romidepsin alone verses romidepsin plus pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary objectives will be to identify a 75% improvement in progression free survival (PFS) among patients receiving the combination compared to single agent romidepsin.

NCT03355768 Lymphoma, T-Cell, Peripheral
MeSH: Lymphoma Lymphoma, T-Cell, Peripheral Lymphoma, T-Cell
HPO: Lymphoma T-cell lymphoma

2 Interventions

Name: Romidepsin

Description: Intravenous administration on a 28 day cycle

Type: Drug

Romidepsin Arm Romidepsin + Pralatrexate Combination Arm

Name: Pralatrexate

Description: Intravenous administration on a 28 day cycle

Type: Drug

Romidepsin + Pralatrexate Combination Arm


Primary Outcomes

Description: Compare the progression free survival (PFS) in patients with R/R PTCL treated with romidepsin versus the combination of romidepsin plus pralatrexate.

Measure: Progression Free Survival

Time: up to 3 years

Secondary Outcomes

Description: Contrast the complete response rate (CR) for patients treated with romidepsin or romidepsin plus pralatrexate.

Measure: Complete Response (CR)

Time: up to 3 years

Description: Contrast the duration of response (DOR) for patients treated with romidepsin or romidepsin plus pralatrexate.

Measure: Duration of response (DOR)

Time: up to 3 years

Description: Contrast the overall survival (OS)for patients treated with romidepsin or romidepsin plus pralatrexate.

Measure: Overall survival (OS)

Time: up to 3 years

Description: Contrast the overall response rate (ORR) for patients treated with romidepsin or romidepsin plus pralatrexate.

Measure: Overall response rate (ORR)

Time: up to 3 years

Description: TTP measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.

Measure: Time to Treatment Progression (TTP)

Time: up to 3 years

Description: TTR measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.

Measure: Time to Relapse (TTR)

Time: up to 3 years

Description: Describe the maximum number of cycles and planned dose intensity of all drugs in both arms in patients with R/R PTCL treated with romidepsin or romidepsin plus pralatrexate.

Measure: Maximum Number of Treatment Cycles

Time: Up to 6 months

Purpose: Other

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 Q21D

There were 3 dose-limiting toxicities (DLTs) in cohort 4 (pralatrexate 20mg/m2 & romidepsin 12mg/m2given weekly x 2 Q21D) consisting of 2 Grade 3 oral mucositis and 1 Grade 4 sepsis. --- Q21D ---


2 Q28D

The every other week (QOW Q28D) schedule had no DLTs at equivalent and higher doses. --- Q28D ---



HPO Nodes


HPO:
Lymphoma
Genes 94
BLM MYC CDKN2A KRAS MYD88 RMRP RAG1 RAG2 MALT1 MSH6 RASGRP1 LIG4 TCF4 PMS2 ICOS NRAS WAS WIPF1 CD19 MS4A1 USB1 IGH TINF2 RB1 DCLRE1C TNFSF12 RTEL1 CTC1 CD27 CD28 PIK3R1 PRF1 NTHL1 TP63 POLE HLA-DRB1 NFKB1 NFKB2 RECQL4 RAD54B CHEK2 TNFRSF13C APC MLH1 TNFRSF13B DKC1 BIRC3 XIAP CASP10 NBN PRKCD COL14A1 FOXP1 CD81 PARN NOP10 CCND1 BCL10 BCL2 MSH2 CHD7 CTLA4 ATM BCL6 MAGT1 RUNX1 TNFRSF1B XRCC4 WRAP53 PTEN MDM2 FAS NHP2 ADA FASLG CR2 SH2D1A TERC AAGAB KIT TERT NSUN2 IL2RG LYST RNF43 ZAP70 DNASE1L3 TP53 RAD54L ITK STAT3 IL7R KIF11 PNP
T-cell lymphoma
Genes 10
POLE FAS FASLG CTLA4 CASP10 NBN CD28 PRKCD RASGRP1 TNFRSF1B