Status:
TERMINATED
Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia
Lead Sponsor:
AGC Biologics S.p.A.
Conditions:
Acute Leukemia (Category)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 l...
Detailed Description
Delayed immune-reconstitution remains one of the main limitation of haploidentical stem cell transplantation. The risk of severe infections remains high for several months and CD3+ reconstitution coul...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
April 12 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00914628
Start Date
April 12 2010
End Date
November 30 2019
Last Update
June 22 2021
Active Locations (36)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
Washington University Medical School
St Louis, Missouri, United States, 63110
3
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
4
Universitair Ziekenhuis
Ghent, Belgium