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Report for Clinical Trial NCT01769911

Developed by Shray Alag, 2020.
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 Ly 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:Mycoses Burkitt Lymphoma 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, T-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Plasmablastic Lymphoma 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 Intraocular Lymphoma Leukemia, Large Granular Lymphocytic Lymphoma, AIDS-Related Immunoblastic Lymphadenopathy
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
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 ---



HPO Nodes


HPO: