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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05226455
Other study ID # VENTOGRAFT
Secondary ID 2021-000632-56
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 23, 2022
Est. completion date March 1, 2026

Study information

Verified date April 2024
Source Groupe Francophone des Myelodysplasies
Contact Fatiha CHERMAT
Phone 01 71 20 70 59
Email fatiha.chermat-ext@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study to assess venetoclax + azacitidine and donor lymphocyte infusion (DLI) in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) with blasts < 30% in relapse after allohematopoietic stem cell transplantation (AHSCT).


Description:

A phase I-II study to assess venetoclax + azacitidine and donor lymphocyte infusion (DLI) in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) with blasts < 30% in relapse after allohematopoietic stem cell transplantation (AHSCT).


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
venetoclax + azacitidine +/- donor lymphocyte infusion
Venetoclax will be given once daily orally on days 1 to 14 for all cycles. Venetoclax + azacitidine +/- donor lymphocyte infusion (12 cycles maximum)

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Sponsors (2)

Lead Sponsor Collaborator
Groupe Francophone des Myelodysplasies AbbVie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Correlation between patient overall mutational status before and after treatment Mutational analysis performed by NGS (next-generation sequencing) at screening and then at each protocol evaluation (post 4, 6 and 8 cycles of venetoclax + azacitidine and at end of study) At 42 months (at end of study)
Other Prognostic impact of Minimal Residual Disease (MRD) on outcome Minimal Residual Disease (MRD) assessment by flow cytometry and allelic variant frequency (VAF) of baseline mutations At 42 months (at end of study)
Primary Phase I: Dose-finding study Evaluation of Dose-limiting toxicity (DLT) to determine the optimal dose level in terms of both toxicity and safety for venetoclax + azacitidine At the end of cycle 1 of venetoclax + azacitidine (each cycle is 28 days)
Primary Phase II: Overall improvement rate of venetoclax + azacitidine +/- DLI Response assessment performed according to modified IWG (International Working Group) 2006 criteria for myelodysplastic syndrome and to European Leukemia Net criteria for acute myeloid leukemia After 8 cycles of venetoclax + azacitidine (each cycle is 28 days)
Secondary Toxicity assessment Adverse events analyzed by frequency, NCI CTCAE 5.0 grade, and causality At 42 months (at end of study)
Secondary Graft-versus-Host-Disease (GVHD) rate Acute and chronic graft-versus-host-disease (GVHD) rate assessment (graft-versus-host events analyzed by frequency and grade) At 42 months (at end of study)
Secondary Duration of response Duration of response defined as time from the date of the first observed response (complete or partial) to the date of first subsequent documented disease progression or relapse or death At 42 months (at end of study)
Secondary Overall survival Overall Survival defined as time from the date of the first dose of venetoclax to the date of death or end of study At 42 months (at end of study)
Secondary Progression-free survival Progression-free Survival for patients with at least a partial response defined as time from the date of the first dose of venetoclax to the date of the first documented disease progression or relapse or death At 42 months (at end of study)
Secondary Event-free survival Event-free Survival defined as time from the date of the first dose of venetoclax to the date of earliest disease progression or death At 42 months (at end of study)
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