18 and older, any sex, with Acute Leukemia (Category). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Disease-free Survival (DFS)Primary· From the date of randomization, assessed up to 12 months
Defined as the measure from the date of randomization until the date of relapse (or progression), or death from any cause, whichever occurs first.
Disease relapse or progression was determined by the Investigator based on the following disease examination:
* Morphology (bone marrow or peripheral blood)
* Confirmation of mixed or full chimerism (evaluation of the degree of chimerism between donor/host, according to institutional clinical practice, on bone marrow or peripheral blood)
* Cytogenetic and/or molecular and/or other tests, according to institutional clinical practice (bone marrow or
DFS on ITT
Group
Value
95% CI
A-Experimental Arm
45
B - Control Arm
20
A-Experimental Arm
19
B - Control Arm
8
DFS on PP Set
Group
Value
95% CI
A-Experimental Arm
25
B - Control Arm
18
A-Experimental Arm
13
B - Control Arm
8
DFS on ITT - day 21 after transplant
Group
Value
95% CI
A-Experimental Arm
38
B - Control Arm
20
A-Experimental Arm
17
B - Control Arm
8
DFS on PP Set day 21 after transplant
Group
Value
95% CI
A-Experimental Arm
25
B - Control Arm
18
A-Experimental Arm
13
B - Control Arm
8
Overall Survival (OS)Secondary· From the date of randomization to the date of death, assessed up to 12 months
any death without previous occurrence of a documented relapse (or progression).Patients alive or without any follow up will be censored.
OS on ITT
Group
Value
95% CI
A-Experimental Arm
22
B - Control Arm
10
A-Experimental Arm
42
B - Control Arm
18
OS on PP Set
Group
Value
95% CI
A-Experimental Arm
14
B - Control Arm
10
A-Experimental Arm
24
B - Control Arm
16
OS on ITT- day 21 after transplant
Group
Value
95% CI
A-Experimental Arm
20
B - Control Arm
10
A-Experimental Arm
35
B - Control Arm
18
OS on PP Set - day 21 after transplant
Group
Value
95% CI
A-Experimental Arm
18
B - Control Arm
10
A-Experimental Arm
33
B - Control Arm
18
Immune Reconstitution (IR)Secondary· Weekly up to IR after engraftment of HCT, monthly for 6 months from date of IR and then at month 9 and 12
Assess how many patients experience IR. For the assessment, competing risk analysis was performed considering death, relapse, and disease progression as competing events. Patients who were still alive and had no recovery (IR) nor relapse (or progression) were censored.IR is defined as achieving a level of circulating CD3+ ≥ 100/μL for two consecutive observations. The following laboratory examinations are performed:
* Hematology: WBC (full and differential), RBC, platelets, Hb, Htc, MCV, MPV, serology CMV (PCR and antigenemia).
* Blood chemistry: AST, ALT, γGT, total bilirubin, LDH.
IR on ITT
Group
Value
95% CI
A-Experimental Arm
38
B - Control Arm
22
A-Experimental Arm
13
B - Control Arm
5
A-Experimental Arm
6
B - Control Arm
1
A-Experimental Arm
1
B - Control Arm
0
IR on PP Set
Group
Value
95% CI
A-Experimental Arm
29
B - Control Arm
22
A-Experimental Arm
4
B - Control Arm
3
A-Experimental Arm
5
B - Control Arm
1
A-Experimental Arm
0
B - Control Arm
0
Cumulative Incidence of Relapse (CIR)Secondary· from the date of randomization to the date of the first occurrence of relapse, assessed up to 12 months
Defined on the basis of morphologic evidence of leukaemia in bone marrow or other sites. Gray's test was used to compare the sub-distribution functions of relapse (or progression) events in the two treatment groups. Patients alive without relapse (or regression) will be censored
CIR on ITT population - CIR
Group
Value
95% CI
A-Experimental Arm
18
B - Control Arm
11
A-Experimental Arm
27
B - Control Arm
9
A-Experimental Arm
19
B - Control Arm
8
CIR on PP Set
Group
Value
95% CI
A-Experimental Arm
11
B - Control Arm
11
A-Experimental Arm
14
B - Control Arm
7
A-Experimental Arm
13
B - Control Arm
8
Non-relapse Mortality (NRM)Secondary· From the date of randomization to the date of death, assessed up to 12 months.
Defined for all patients as any death without previous occurrence of a documented relapse (or progression). Absence of relapse was determined by the Investigator based on the following disease examination:
* Morphology (bone marrow or peripheral blood)
* Confirmation of mixed or full chimerism (evaluation of the degree of chimerism between donor/host, according to institutional clinical practice, on bone marrow or peripheral blood)
* Cytogenetic and/or molecular and/or other tests, according to institutional clinical practice (bone marrow or peripheral blood).
Gray's test was used to compare
NRM on ITT population
Group
Value
95% CI
A-Experimental Arm
27
B - Control Arm
9
A-Experimental Arm
18
B - Control Arm
11
A-Experimental Arm
19
B - Control Arm
8
NRM on PP Set
Group
Value
95% CI
A-Experimental Arm
14
B - Control Arm
7
A-Experimental Arm
11
B - Control Arm
11
A-Experimental Arm
13
B - Control Arm
8
Adverse events — posted to ClinicalTrials.gov
Time frame: From day 21 through day 180 or at least 30 days after last dose of HSV-TK..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A-Experimental Arm
Serious: 35/53 (66%)
Deaths: 35/53
B - Control Arm
Serious: 17/27 (63%)
Deaths: 17/27
Serious adverse events (75 terms)
Reaction
System
A-Experimental Arm
B - Control Arm
Moderate Acute graft versus host disease
Immune system disorders
—
—
Severe Acute graft versus host disease
Immune system disorders
—
—
Moderate Chronic graft versus host disease
Immune system disorders
—
—
Severe Chronic graft versus host disease
Immune system disorders
—
—
Severe Pneumonia
Infections and infestations
—
—
Life threatening Septic shock
Infections and infestations
—
—
Life threatening leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Severe Post transplant lymphoproliferative disorder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AGC Biologics S.p.A.
Last refreshed: 22 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00914628.