Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Histone Deacetylase Inhibitors

Mocetinostat

Antimetabolites

Enzyme Inhibitors

75 mg/m2/day for 5 days, subcutaneous (SC) injection, Days 1 - 5 of every 28-day cycle

90 mg, oral (PO) administration, 3 times per week for 12 doses, 28-day cycle

MGCD0103

90 mg, oral (PO) administration, 3 times per week for 10 doses, 28-day cycle

Gregory Reid, MSc, MBA

The purpose of the study is to determine how effective azacitidine, MGCD0103, and the combination of azacitidine and MGCD0103 are in treating AML or MDS in people over 60 years of age.

This randomized, 3-arm Phase 2 study will compare the safety and efficacy of single-agent azacitidine (currently 1 of 3 approved treatments for myelodysplastic syndrome \[MDS\]) to that of single-agent MGCD0103 and to that of combination therapy with MGCD0103 and azacitidine in elderly patients with acute myelogenous leukemia (AML) or intermediate-2 (Int-2) or high-risk MDS, for whom no standard of care exists. The goal of the study is to determine which of the 3 treatment arms are worthy of further investigation in a subsequent Phase 3 study of elderly subjects with AML or Int-2 or high-risk MDS.

Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

A Phase 2, Randomized, Open-Label Study of Azacitidine (Vidaza) vs MGCD0103 vs Azacitidine in Combination With MGCD0103 for the Treatment of Elderly Subjects With Newly Diagnosed AML or Intermediate-2 or High-Risk MDS

Mirati Therapeutics Inc.

Antibodies

Antibodies, Monoclonal

Decitabine

Immunoglobulins

Immunoglobulins, Intravenous

Myeloma Proteins

Paraproteins

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Patients will be administered Camrelizumab(SHR-1210) at D1 and D15 and decitabine at D1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity.

Camrelizumab(SHR-1210)

Kai Xue

Hongming Zhu

Junmin Li

This is an open-label, single arm, phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with DNA methyltransferase inhibitor decitabine in elderly patients with relapse and refractory acute myeloid leukemia.

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, 29 relapsed or refractory acute myeloid leukemia patients will be enrolled. Patients will be administered Camrelizumab(SHR-1210) at D1 and D15 and decitabine at D1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity.

Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia

Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia : An Open-Label, Single-Arm, Phase 2 Study.

CR, CRi, and morphologic leukemia-free state (MLFS)

Blast and promyelocytic leukemia less than 5% in bone marrow

PFS is defined from the date of entry on study until disease progression, including treatment failure, relapse from CR, or death from any causes.

OS is defined for patients entering the study as time to death of all causes.

To evaluate overall survival rate at 6 months from study entry.

To evaluate overall survival rate at 12 months from study entry.

Assessed according to the Common Terminology Criteria for Adverse Events Version 4.03.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)	NCT00666497	Acute Myeloid L... Myelodysplastic...	Azacitidine MGCD0103 MGCD0103	60 Years -	Mirati Therapeutics Inc.
Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia	NCT04353479	Acute Myeloid L...	Camrelizumab(SH... Decitabine	60 Years - 75 Years	Shanghai Jiao Tong University School of Medicine

Spots Global Cancer Trial Database for dna methyltransferase inhibitor