SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01769911

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

AUTOLOGOUS TRANSPLANTATION AND STEM CELL BASED-GENE THERAPY FOR THE TREATMENT OF HIV-ASSOCIATED LYMPHOMA

This clinical trial studies genetically modified peripheral blood stem cell transplant in treating patients with HIV-associated non-Hodgkin or Hodgkin lymphoma. Giving chemotherapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. Laboratory-treated stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy

NCT01769911 Adult Nasal Type Extranodal NK/T-cell Lymphoma AIDS-related Diffuse Large Cell Lymphoma AIDS-related Diffuse Mixed Cell Lymphoma AIDS-related Diffuse Small Cleaved Cell Lymphoma AIDS-related Immunoblastic Large Cell Lymphoma AIDS-related Lymphoblastic Lymphoma AIDS-related Peripheral/Systemic Lymphoma AIDS-related Small Noncleaved Cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma HIV-associated Hodgkin Lymphoma Intraocular Lymphoma Nodal Marginal Zone B-cell Lymphoma Noncutaneous Extranodal Lymphoma Peripheral T-cell Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Refractory Hairy Cell Leukemia Small Intestine Lymphoma Splenic Marginal Zone Lymphoma Stage I AIDS-related Lymphoma Stage II AIDS-related Lymphoma Stage III AIDS-related Lymphoma Stage IV AIDS-related Lymphoma T-cell Large Granular Lymphocyte Leukemia Testicular Lymphoma Waldenström Macroglobulinemia
MeSH: Lymphoma Leukemia Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, B-Cell Hodgkin Disease Lymphoma, Mantle-Cell Lymphoma, B-Cell, Marginal Zone Leukemia, Lymphocytic, Chronic, B-Cell Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, T-Cell Burkitt Lymphoma Lymphoma, Large-Cell, Immunoblastic Plasmablastic Lymphoma Mycoses Mycosis Fungoides Sezary Syndrome Lymphoma, T-Cell, Cutaneous Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Waldenstrom Macroglobulinemia Lymphoma, Large-Cell, Anaplastic Lymphoma, T-Cell, Peripheral Leukemia, Hairy Cell Lymphomatoid Granulomatosis Lymphoma, Extranodal NK-T-Cell Immunoblastic Lymphadenopathy Intraocular Lymphoma Leukemia, Large Granular Lymphocytic Lymphoma, AIDS-Related
HPO: Anaplastic large-cell lymphoma B-cell lymphoma Burkitt lymphoma Chronic lymphatic leukemia Cutaneous T-cell lymphoma Hodgkin lymphoma Leukemia Lymphoma Monoclonal immunoglobulin M proteinemia Non-Hodgkin lymphoma T-cell lymphoma

8 Interventions

Name: carmustine

Description: Given IV

Type: Drug

Treatment (gene modified peripheral blood cell transplant)

Name: cytarabine

Description: Given IV

Type: Drug

Treatment (gene modified peripheral blood cell transplant)

Name: melphalan

Description: Given IV

Type: Drug

Treatment (gene modified peripheral blood cell transplant)

Name: etoposide

Description: Given IV

Type: Drug

Treatment (gene modified peripheral blood cell transplant)

Name: O6-benzylguanine

Description: Given IV

Type: Drug

Treatment (gene modified peripheral blood cell transplant)

Name: autologous hematopoietic stem cell transplantation

Description: Undergo transduced and/or non-transduced transplant

Type: Procedure

Treatment (gene modified peripheral blood cell transplant)

Name: peripheral blood stem cell transplantation

Description: Undergo transduced and/or non-transduced transplant

Type: Procedure

Treatment (gene modified peripheral blood cell transplant)

Name: laboratory biomarker analysis

Description: Correlative studies

Type: Other

Treatment (gene modified peripheral blood cell transplant)


Primary Outcomes

Measure: Safety of infusion of gene-modified cells, measured by grade 3 or greater toxicities related to infusion of gene-modified cells using the Common Toxicity Criteria version 4.0(CTCv.4)

Time: Up to day 180

Measure: Safety of O6BG/BCNU in vivo selection, defined as less than 25% of patients developing grade 3 or greater non-hematopoietic toxicity or grade 4 CTCv.4 hematopoietic toxicity

Time: Up to day 180

Measure: Safety of structured treatment interruption defined as no decline in CD4 count by more than 25%, no HIV RNA more than 10,000 copies/mL; and no elevation of immune activation markers

Time: During the 12 weeks without HAART

Measure: Efficacy of gene transduction, defined as collection of more than 4.5 x 10^6 CD34+ cells/kg cells for genetic modification and evidence of gene-marked cells before HSC infusion

Time: Up to 3 months

Measure: Efficacy of infusion of gene-modified cells, defined as engraftment of at least1% gene-modified cells

Time: Up to 3 months

Measure: Efficacy of O6BG/BCNU in vivo selection, defined as selection of gene-modified cells to a level at least 10% of peripheral blood cells

Time: Up to 3 months

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P140K

Determine the correlation of the level of O6-methylguanine- methyltransferase (MGMT) (P140K) marking with toxicity and response. --- P140K ---



HPO Nodes


HPO:
Anaplastic large-cell lymphoma
B-cell lymphoma
Genes 15
FAS ADA FASLG IGH BIRC3 CASP10 NBN MALT1 PRKCD RASGRP1 FOXP1 PIK3R1 CCND1 BCL10 ATM
Burkitt lymphoma
Genes 6
MYC FAS FASLG CASP10 PRKCD RASGRP1
Chronic lymphatic leukemia
Genes 8
SAMHD1 RNASEH2B ADAR RNASEH2A IFIH1 RNASEH2C TREX1 PIK3R1
Cutaneous T-cell lymphoma
Genes 3
CTLA4 CD28 TNFRSF1B
Hodgkin lymphoma
Genes 12
POLE FAS FASLG AAGAB ATM DKC1 CASP10 PRKCD RASGRP1 TCF4 COL14A1 RNF43
Leukemia
Genes 125
MPL RNASEH2B KRAS NPM1 TET2 MYD88 TSR2 RPL26 RPL27 TREX1 EFL1 PIGL SCN11A FLT3 PMS2 RPL35A EVC2 ABL1 CEBPA RARA NRAS WAS WIPF1 ATRX SH2B3 PDGFRA RB1 RNASEH2A PDGFRB CALR ARHGAP26 SH3GL1 RPS7 RPS10 NUMA1 GATA1 GATA2 RPS15A APC NSD1 ETV6 TCIRG1 DNAJC21 EVC SRP54 RPS17 NBN RPS19 SAMHD1 MSH2 RPS24 NUP214 RPS26 RPS27 RPS28 RPS29 MLLT10 RUNX1 XRCC4 CBFB CBL BCR ADAR TRIP13 ADA2 NSUN2 CREBBP PICALM GFI1 F13A1 F13B FANCA FANCC BLM FANCD2 FANCE NUTM1 JAK2 IFIH1 TYROBP MSH6 FANCG LIG4 PTPN11 SAMD9L THPO NF1 STS PIGA BRCA2 DYNC2LI1 PIK3CA SBDS GLI1 PIK3R1 BRD4 SETBP1 RNASEH2C LPP BUB1 BUB1B SCN9A SCN10A TREM2 MLF1 MLH1 ELANE DKC1 ATM HAX1 RPL35 GNB1 BUB3 CEP57 TAL1 KIT TAL2 RPL5 EP300 TP53 RPL11 KIF11 RPL15 DNMT3A RPL18
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
Monoclonal immunoglobulin M proteinemia
Genes 1
MYD88
Non-Hodgkin lymphoma
Genes 22
MYC FAS ADA FASLG IGH KIT BIRC3 CASP10 NBN CD28 MALT1 PRKCD RASGRP1 FOXP1 PIK3R1 NTHL1 POLE CCND1 BCL10 CTLA4 ATM TNFRSF1B
T-cell lymphoma
Genes 10
POLE FAS FASLG CTLA4 CASP10 NBN CD28 PRKCD RASGRP1 TNFRSF1B