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

Universitätsklinikum Hamburg-Eppendorf

Status and phase: Terminated; Phase 2; Phase 1

Conditions: AIDS-related Lymphoma; HIV Infections

Treatments: Procedure: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)

Study type: Interventional

Funder types: Other

Identifiers

NCT00858793

ARL-GT 2005

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

A

Experimental group

Treatment:

Procedure: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)