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Report for Clinical Trial NCT03355768

Developed by Shray Alag, 2020.
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 + Pralatrexate Combination Arm Romidepsin 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 133
ATM KRAS CD19 IGH DDX41 BCL10 BIRC3 FOXP1 MS4A1 TP63 RAG1 LIG4 NFKB2 MSH6 TERC RECQL4 NTHL1 WIPF1 CTC1 LYST NOP10 RASGRP1 TNFRSF1B XRCC4 PRKCD NHP2 MAGT1 TNFRSF13B IGH RMRP RUNX1 CTLA4 DCLRE1C FAS ICOS RNF43 NSUN2 XIAP IL7R CASP10 BCL6 CDKN2A ATM IL2RG RTEL1 PARN NBN KIT TNFRSF13C TCF4 ICOS TNFSF12 CHEK2 USB1 CD19 CR2 NRAS MSH2 WAS BCL10 CASP10 MYD88 COL14A1 PRKCD TNFRSF13B MYC MDM2 SH2D1A CCND1 BCL10 CFTR CD27 PGM3 TCF4 CHD7 IGH LIG4 BLM BCL2 TET2 HLA-DRB1 PRSS1 NPM1 KIF11 ITK WRAP53 RAD54B TINF2 FAS DKC1 APC CD81 LIG4 BLM CD28 DKC1 AAGAB RAG2 TNFRSF1B MLH1 TNFRSF13C DNASE1L3 NFKB1 PMS2 ASXL1 IL2RG PRF1 PTEN MALT1 RAD54L CTLA4 CD28 PNP SRSF2 TNFSF12 STAT3 POLE ADA CR2 ADA FASLG PIK3R1 TP53 CTRC ZAP70 MYD88 RB1 RMRP SPINK1 TERT KLHDC8B NBN RHOH
T-cell lymphoma
Genes 14
POLE FAS CASP10 CTLA4 FAS FASLG CD28 TNFRSF1B RASGRP1 TNFRSF1B PRKCD CTLA4 CD28 NBN