CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 49 enrolled / 49 target
Drug / intervention
Cytarabine +11 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/NCT04214249
NCT04214249Phase 2ActiveUpdate Overdue (0.8/mo)Completion was 19mo ago

BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-1): A Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination With Conventional Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia

National Cancer Institute (NCI)·interventional·Posted Jan 2, 2020·Updated Jun 12, 2026

In Brief

A Phase 2 clinical trial evaluating Biospecimen Collection, Bone Marrow Aspiration, and 10 other interventions for Acute Myeloid Leukemia and 3 related conditions. Active but no longer recruiting, targeting 49 participants across 10 sites.

Signals

Enrollment appears stalled

Detailed Summary

This phase II trial studies how well cytarabine and idarubicin or daunorubicin with or without pembrolizumab work in treating patients with newly-diagnosed acute myeloid leukemia. Chemotherapy drugs, such as cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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 induction chemotherapy with pembrolizumab may work better than induction chemotherapy alone in treating patients with acute myeloid leukemia.

Study Details

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

Timeline

Phase 2Active
20202021202220232024202520262027
First PostedJan 2, 2020
Enrollment StartFeb 17, 2021
Primary CompletionNov 27, 2024
Study CompletionJan 30, 2027
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.5 years ago

Arms & Interventions

Arm I (cytarabine, idarubicin,daunorubicin,pembrolizumab,HSCT)experimental

See Detailed Description.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyDrug: CytarabineDrug: Daunorubicin HydrochlorideProcedure: Echocardiography TestProcedure: Hematopoietic Cell TransplantationDrug: Idarubicin HydrochlorideProcedure: Multigated Acquisition ScanBiological: PembrolizumabProcedure: Punch Biopsy
Arm II (cytarabine, idarubicin, daunorubicin, HSCT)active_comparator

See Detailed Description.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyDrug: CytarabineDrug: Daunorubicin HydrochlorideProcedure: Echocardiography TestProcedure: Hematopoietic Cell TransplantationDrug: Idarubicin HydrochlorideProcedure: Multigated Acquisition ScanProcedure: Punch Biopsy

Interventions

Biospecimen Collectionprocedure

Undergo collection of blood

Bone Marrow Aspirationprocedure

Undergo bone marrow aspiration

Bone Marrow Biopsyprocedure

Undergo bone marrow biopsy

Computed Tomographyprocedure

Undergo CT

Cytarabinedrug

Given via continuous IV infusion

Daunorubicin Hydrochloridedrug

Given IV

Echocardiography Testprocedure

Undergo ECHO

Hematopoietic Cell Transplantationprocedure

Undergo HSCT

Idarubicin Hydrochloridedrug

Given IV

Multigated Acquisition Scanprocedure

Undergo MUGA

Pembrolizumabbiological

Given IV

Punch Biopsyprocedure

Undergo a skin punch biopsy