TerminatedPhase 3

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

Stopped: 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

United States, Belgium92 participantsStarted 2010-04-12

Plain-language 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 lymphocytes or standard haploidentical HCT

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Disease-free Survival (DFS)

Timeframe: From the date of randomization, assessed up to 12 months

Trial details

NCT IDNCT00914628

SponsorAGC Biologics S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-30

Results submitted2021-02-12

View on ClinicalTrials.gov More Acute Leukemia (Category) trials