Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia
Stopped early · Phase 3
Conditions studied: Acute Leukemia (Category)
In brief
The main objective of this randomized trial is to compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT
Key facts
- Study ID
- NCT00914628
- Run by
- AGC Biologics S.p.A.
- People needed
- 92
- Starts
- 2010-04-12
- Expected to finish
- 2019-11-30
- Last updated by the study team
- 2021-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Any of the following conditions:
- AML and ALL in 1st complete remission (CR1)
- AML and ALL in 2nd or subsequent CR
- secondary AML in CR
- 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
You may not qualify if…
- 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)
Where it is running
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
- Washington University Medical School — St Louis, Missouri, United States
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
- Universitair Ziekenhuis — Ghent, Belgium
- University Hospitals Leuven — Leuven, Belgium
- Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman — Liège, Belgium
- Hôpital Jean Minjoz — Besançon, France
- Centre Hospitalier Universitaire de Clermont-Ferrand — Clermont-Ferrand, France
- Centre Hospitalier Régional Universitaire de Lille — Lille, France
- Institut Paoli-Calmettes — Marseille, France
- Centre Hospitalier Universitaire de Nantes — Nantes, France
- Hôpital l'Archet — Nice, France
- Hôpital Saint-Antoine — Paris, France
- IUCT Oncopole - Institut Universitaire du Cancer de Toulouse — Toulouse, France
- Charitè; Campus Benjamin Franklin — Berlin, Germany
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany
- Medizinische Hochschule Hannover — Hanover, Germany
- University of Leipzig — Leipzig, Germany
- Universitat Tubingen — Tübingen, Germany
- Medizinische Klinik und Poliklinik — Ulm, Germany
- George Papanicolaou Hospital — Thessaloniki, Greece
- Chaim Sheba Medical Center — Tel Litwinsky, Israel
- Azienda Sanitaria Ospedaliera S.Croce e Carle — Cuneo, CN, Italy
- Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele — Catania, CT, Italy
- Azienda Ospedaliera Universitaria Careggi — Florence, FI, Italy
Full record on ClinicalTrials.gov
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