CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 60 enrolled / 60 target
Drug / intervention
Azacitidine +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04284787
NCT04284787Phase 2ActiveUpdate Overdue (0.9/mo)Completion was 36mo ago

BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2 (BLAST MRD AML-2): A Randomized Phase 2 Study of the Venetoclax, Azacitadine, and Pembrolizumab (VAP) Versus Venetoclax and Azacitadine as First Line Therapy in Older Patients With Acute Myeloid Leukemia (AML) Who Are Ineligible or Who Refuse Intensive Chemotherapy

National Cancer Institute (NCI)·interventional·Posted Feb 26, 2020·Updated Jun 1, 2026

In Brief

A Phase 2 clinical trial evaluating Azacitidine, Biopsy Procedure, and 7 other interventions for Acute Myeloid Leukemia and 3 related conditions. Active but no longer recruiting, targeting 60 participants across 29 sites.

Signals

Enrollment appears stalled

Detailed Summary

This phase II trial studies how well azacitidine and venetoclax with or without pembrolizumab work in treating older patients with newly diagnosed acute myeloid leukemia. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving azacitidine and venetoclax with pembrolizumab may increase the rate of deeper/better responses and reduce the chance of the leukemia coming back in patients with newly diagnosed acute myeloid leukemia compared to conventional therapy of azacitidine and venetoclax alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
20202021202220232024202520262027
First PostedFeb 26, 2020
Enrollment StartFeb 16, 2021
Primary CompletionJun 5, 2023
Study CompletionJan 30, 2027
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.4 years ago

Arms & Interventions

Arm I (AZA, VEN)active_comparator

See Detailed Description

Drug: AzacitidineProcedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Echocardiography TestProcedure: Multigated Acquisition ScanDrug: Venetoclax
Arm II (AZA, VEN, pembrolizumab)experimental

See Detailed Description

Drug: AzacitidineProcedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Echocardiography TestProcedure: Multigated Acquisition ScanBiological: PembrolizumabDrug: Venetoclax

Interventions

Azacitidinedrug

Given IV or SC

Biopsy Procedureprocedure

Undergo biopsy

Biospecimen Collectionprocedure

Undergo blood specimen collection

Bone Marrow Aspirationprocedure

Undergo bone marrow aspiration

Bone Marrow Biopsyprocedure

Undergo bone marrow biopsy

Echocardiography Testprocedure

Undergo ECHO

Multigated Acquisition Scanprocedure

Undergo MUGA scan

Pembrolizumabbiological

Given IV

Venetoclaxdrug

Given PO