Last updated on September 2018

Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute Leukemia | Acute Leukemia (Category)
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age 18 years
  • Any of the following conditions:
    1. AML and ALL in 1st complete remission (CR1)
    2. AML and ALL in 2nd or subsequent CR
    3. secondary AML in CR
    4. AML and ALL in 1st or 2nd relapse or primary refractory
  • Family donor with patient-donor number of HLA mismatches 2 (full haploidentical), or family donors sharing one HLA-haplotype with the patient
  • Stable clinical conditions and life expectancy > 3 months
  • PS ECOG < 2
  • Serum creatinine < 1.5 x ULN
  • Bilirubin < 1.5 x ULN; transaminases < 3 x ULN
  • Left ventricular ejection fraction > 45%
  • QTc interval < 450 ms
  • DLCO > 50%
  • Patients, or legal guardians, and donors must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects

Exclusion Criteria:

  • Patients with life-threatening condition or complication other than their basic condition
  • Contraindication to haploidentical HCT as defined by the Investigator
  • Patients with active CNS disease
  • Pregnant or lactation.

Exclusion criteria for HSV-Tk infusion:

  • Infections requiring administration of ganciclovir or valganciclovir at the time of infusion
  • GvHD requiring systemic immunosuppressive therapy
  • Ongoing systemic immunosuppressive therapy after haploidentical HCT
  • Administration of G-CSF after haploidentical HCT

HSV-Tk cells can be administered after an adequate patient wash-out period (24 hours)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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