High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT

Phase 2TerminatedNCT00858793

Universitätsklinikum Hamburg-Eppendorf5 enrolled

Overview

Patient stem cells will be mobilized with induction chemotherapy (R)-ICE and G-CSF. If sufficient cells can be mobilized, patients will be treated with high-dose chemotherapy and a transplant of autologous CD34+ cells transduced with an antiviral vector (M87o). If autologous CD34+ yield is insufficient, allogeneic gene-modified cells will be given, if a compatible donor is available. To minimize risk of transplant failure, a second unmodified CD34+ cell transplant will be given one week after the first transplant.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

AIDS-related Lymphoma HIV Infections

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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, Hodgkin disease, plasmocytoma, acute and chronic leukaemia) who failed to achieve complete remission (CR) after standard-dose first-line chemotherapy or had a chemosensitive relapse after an initial CR * Patients must receive HAART Exclusion Criteria: * Any of the following conditions: * congestive heart failure (NYHA \> II) * documented EBV, HBV or HCV infection (only for allogeneic PBSCT) * creatinine clearance \< 60 ml/min * left ventricular ejection fraction \< 40% * bilirubin \> 2 mg/dl * Severe opportunistic infection * More than 10% of bone marrow involved with lymphoma * Between 2 and 5 10\^6 autologous CD34+ cells/kg BW 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 product 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 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 have previously been admitted to this study * Patients who will not accept transfusions of blood products