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Report for Clinical Trial NCT01769911
 Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene 
      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
    
Name: carmustine
Description: Given IV
 Type: Drug
Group Labels:  1  Treatment (gene modified peripheral blood cell transplant)  
 Name: cytarabine
Description: Given IV
 Type: Drug
Group Labels:  1  Treatment (gene modified peripheral blood cell transplant)  
 Name: melphalan
Description: Given IV
 Type: Drug
Group Labels:  1  Treatment (gene modified peripheral blood cell transplant)  
 Name: etoposide
Description: Given IV
 Type: Drug
Group Labels:  1  Treatment (gene modified peripheral blood cell transplant)  
 Name: O6-benzylguanine
Description: Given IV
 Type: Drug
Group Labels:  1  Treatment (gene modified peripheral blood cell transplant)  
 Name: autologous hematopoietic stem cell transplantation
Description: Undergo transduced and/or non-transduced transplant
 Type: Procedure
Group Labels:  1  Treatment (gene modified peripheral blood cell transplant)  
 Name: peripheral blood stem cell transplantation
Description: Undergo transduced and/or non-transduced transplant
 Type: Procedure
Group Labels:  1  Treatment (gene modified peripheral blood cell transplant)  
 Name: laboratory biomarker analysis
Description: Correlative studies
 Type: Other
Group Labels:  1  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
Allocation: N/A
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 ---