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High-Dose Chemotherapy With Transplantation of Gene-Modified Stem Cells for High-Risk AIDS-Related Lymphoma

Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
AIDS-Related Lymphoma, HIV Infections

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Trial Information

High-Dose Chemotherapy With Transplantation of Gene-Modified Stem Cells for High-Risk AIDS-Related Lymphoma

Inclusion Criteria:

- Male and female patients of any ethnic group aged between 18 and 65 years

- HIV-positive patients with NHL 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 < 50%

- bilirubin > 2 mg/dl

- Not-treated opportunistic infection

- Not-treated CNS involvement of lymphoma

- Isolated CNS relapse of the lymphoma without other evidence of active disease

- 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

- 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

- Patients who have previously been admitted to this study

- Patients who will not accept transfusions of blood products

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events, ECOG performance status and laboratory safety tests

Outcome Time Frame:

five years after transplantation

Safety Issue:



Germany: Federal Institute for Drugs and Medical Devices

Study ID:

ARL-GT 2005



Start Date:

October 2008

Completion Date:

October 2016

Related Keywords:

  • AIDS-Related Lymphoma
  • HIV Infections
  • AIDS
  • HIV
  • Lymphoma
  • Stem Cell Transplantation
  • gene-modified Stem Cells
  • treatment experienced
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Lymphoma
  • Lymphoma, AIDS-Related