HIV-positive patients with any malignant disease of the haematopoietic system indicating haematopoietic stem cell transplantation (autologous or allogeneic) MedDRA version: 12.1 Level: LLT Classification code 10061624 Term: AIDS related complication
Conditions
Interventions
Product Name: PBSC-M87o
Product Code: PBSC-M87o
Pharmaceutical Form: Intravenous infusion
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male and female patients of any ethnic group aged between 18 and 65 years •HIV-positive patients with malignant diseases of the blood (NHL, Hodgin disease, plasmocytoma, acute and chronic leukaemia) indicating an HSCT: - M.Hodgkin: autologous SCT for relapsed patient, allogeneic SCT for relapse after autologous SCT or primary refractory disease or insufficient autologous stem cell collection - High grade NHL: autologous SCT for relapsed patient, allogeneic SCT for relapse after autologous SCT or primary refractory disease or insufficient autologous stem cell collection - Low grade NHL: autologous SCT for relapse after first or second line treatment, allogeneic SCT for relapse after autologous SCT - Multiple Myeloma: autologous SCT for chemosensitiv or chemorefractory diseases, allogeneic SCT for relapse after autologous SCT - AML: allogeneic SCT for 1. CR with high risk cytogenetic, refractory disease or remissionstatus > 1. CR - ALL: allogeneic SCT for high risk or very high risk disease , non complete or > 1.CR - CML: allogeneic SCT for patient resistant to tyrosine kinase inhibitor treatment •Patients must receive HAART Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Any of the following conditions: congestive heart failure (NYHA > II), documented EBV, HBV or HCV infection (only for allogeneic PBSCT), creatinine clearance 2 mg/dl •Severe opportunistic infection •More than 10% of bone marrow involved with lymphoma •Between 2 and 5 x 106 autologous CD34+ cells /kg body weight obtained after leukapheresis and CD34 enrichment •Women of child-bearing potential not under adequate contraceptive protection •Women who are pregnant or breast feeding •Known history of drug-, medication- or alcohol abuse within the last 12 months preceding the study •Participation in another study with an investigational drug within less than one month prior to this study •Simultaneous participation in a study with an investigational drug •Presence of any disease likely to require procedures altering the schedule of this study •Patients who are unable or unwilling to meet the requirements of the protocol •Patients with a history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator •Patients with limited mental capacity to the extent that he/she cannot provide informed consent or information regarding adverse events of the study medication •Patients with any clinically meaningful renal, hepatic, respiratory or cardiovascular disease •Patients who will not accept transfusions of blood products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the safety and potential toxicity of peripheral blood autologous and allogeneic gene-modified CD34+ hematopoietic progenitor cells given as a rescue for high-dose chemotherapy of malignant diseases indicating HSCT ;Secondary Objective: To reconstitute the immune system of HIV-positive patients with cells protected from HIV infection by an antiviral gene thereby reducing viral load and potentially regenerating immune competence and to achieve continuous complete remission (CCR) in HIV-positive requiring HSCT ;Primary end point(s): 1)Efficacy of elimination of malignant cells and achievement of complete or partial remission 2)Engraftment of stem cells and repopulation of the hematopoietic system 3)Level of virus replication as measured by HIV RNA in plasma 4)Lymphocyte differentiation (CD3/CD4/CD8) analysis as a parameter for immune competence and possible regeneration of the immune system after the trial treatment 5) Toxicity 6) Quality of life | — |
Countries
Germany
Outcome results
None listed