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A study to evaluate how well low-dose venetoclax with posaconazole works and how safe it is in patients with acute blood cancer who are not fit for standard chemotherapy.

A Phase 2 Feasibility Study of the Efficacy and Safety of Low-Dose Venetoclax and Posaconazole in Acute Myeloid Leukemia Patients Not Fit for 3+7 Induction Therapy. - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/109414
Enrollment
81
Registered
2026-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: C920- Acute myeloblastic leukemia

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5: Nil: Nil Intervention6: Nil: Nil

Sponsors

CSR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 years and older are diagnosed with newly diagnosed AML (de-novo or secondary), considered ineligible for induction therapy by the treating physician or in the leukemia joint conducted in Tata Memorial Hospital Patient who provides signed informed consent.

Exclusion criteria

Exclusion criteria: Age more than 75 years.

Design outcomes

Primary

MeasureTime frame
To evaluate composite complete remission rates (CR + CRi)Timepoint: After cycle 1 Induction—

Secondary

MeasureTime frame
To evaluate the incidence and severity of Grade 3/4 hematological and non hematological toxicitiesTimepoint: During Cycle 1 of Azacitidine and low-dose venetoclax in combination with posaconazole;To investigate the pharmacokinetics of Venetoclax specifically steady-state concentrations when co-administered with Posaconazole.Timepoint: Day 18 of induction;To assess the direct cost of treatment during Cycle 1 involving Azacitidine, Venetoclax, and Posaconazole.Timepoint: After Cycle 1 induction—

Countries

India

Contacts

Public ContactDr Manju Sengar

Tata Memorial Hospital

manju.sengar@gmail.com8657517930

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026