Clinical trial · Interventional
Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia
TK008: Randomized Phase III Trial of Haploidentical HCT With or Without an Add Back Strategy of HSV-Tk Donor Lymphocytes in Patients With High Risk Acute Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): EMA withdrew the marketing Authorisation at the request of AGC Biologics S.p.A (formerly MolMed S.p.A), which decided to permanently discontinue the marketing of the product for commercial reasons
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia (Category) | Acute Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HSV-Tk | Genetic | — | UNRESOLVED |
| T-cell depleted or T-cell replete strategies | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- HSV-TK engineering donor Lymphocytes
- interventionNames
- Genetic: HSV-Tk
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- T-cell depleted or T-cell replete strategies
- interventionNames
- Other: T-cell depleted or T-cell replete strategies
Primary outcomes (1)
- measure
- Disease-free Survival (DFS)
- timeFrame
- From the date of randomization, assessed up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available