VENTOGRAFT study: A phase I-II study to assess venetoclax + azacitidine and donor lymphocyte infusion in patients with MDS or AML in relapse after allo hematopoietic stem cell transplantation

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514877-23-00

Acronym

VENTOGRAFT

Enrollment

Registered

2024-10-07

Start date

2022-11-23

Completion date

Unknown

Last updated

2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic syndromes or Acute Myeloid Leukemia

Brief summary

Phase I: To determine toxicity profile and safety of the combination, Phase II: Overall hematological response rate of venetoclax in combination with AZA/DLI. Response assessment will be performed for MDS according to IWG criteria and according to European LeukemiaNet criteria for AML.

Detailed description

Toxicity as measured by NCI CTCAE 5.0, Acute and chronic GVHD rate, Duration of response, Overall survival, Progression-free survival, Event-free survival

Interventions

DRUGVenetoclax

DRUGVidaza 25 mg/ml powder for suspension for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase I: To determine toxicity profile and safety of the combination, Phase II: Overall hematological response rate of venetoclax in combination with AZA/DLI. Response assessment will be performed for MDS according to IWG criteria and according to European LeukemiaNet criteria for AML.	—

Secondary

Measure	Time frame
Toxicity as measured by NCI CTCAE 5.0, Acute and chronic GVHD rate, Duration of response, Overall survival, Progression-free survival, Event-free survival	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026