Actively Recruiting

Phase 2
Age: 18Years - 59Years
All Genders
NCT05554393

Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

153

Participants Needed

177

Research Sites

172 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells. Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. 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. Azacitidine is a drug that interacts with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work better than the usual treatment of cytarabine with daunorubicin alone. To decide if they are better, the study doctors are looking to see if venetoclax increases the rate of elimination of AML in participants by 20% or more compared to the usual approach.

CONDITIONS

Official Title

Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

Who Can Participate

Age: 18Years - 59Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient must be enrolled in MYELOMATCH and assigned to this trial based on an actionable mutation
  • Registered to master screening and re-assessment protocol (myeloMATCH MSRP) before consenting
  • Agreed to submit specimens for translational medicine and future research
  • Previously untreated, de novo AML with >20% myeloblasts excluding favorable cytogenetics and certain mutations
  • Age between 18 and 59 years at induction therapy
  • ECOG performance status of 0 to 3
  • Total bilirubin less than or equal to 2 times institutional upper limit of normal within 7 days of enrollment
  • AST and/or ALT less than or equal to 3 times institutional upper limit of normal within 7 days of enrollment
  • Cardiac ejection fraction of 50% or higher within 14 days if clinically indicated
  • Creatinine clearance of at least 30 mL/min/1.73m2 within 7 days of enrollment
  • White blood cell count less than 25 x 10^9/L before starting protocol therapy
  • Patients with prior or concurrent malignancy that does not interfere with safety or efficacy assessment
  • Cardiac function classified as New York Heart Association class 2B or better
  • Males and females of reproductive potential must agree to use highly effective contraception during and 6 months after treatment
  • Women of childbearing potential must have a negative pregnancy test before study
  • Provided informed consent as per regulatory requirements
  • Must be accessible for treatment, response assessment, and follow-up at participating center
  • Protocol treatment to begin within 7 working days of enrollment
  • Participants on strong or moderate CYP3A inhibitors must discontinue use 48 hours before treatment if assigned to arm 1 or 2
  • Patients with HIV on effective antiretroviral therapy with undetectable viral load within 6 months
  • Patients with chronic hepatitis B infection must have undetectable viral load and be on suppressive therapy if needed
  • Patients with treated and cured hepatitis C or undetectable viral load if currently treated
Not Eligible

You will not qualify if you...

  • Prior therapy for AML except hydroxyurea and leukapheresis
  • Receiving other investigational agents
  • History of allergic reactions to cytarabine, daunorubicin, azacitidine, or venetoclax
  • Pregnant or breastfeeding women
  • Patients with isolated myeloid sarcoma
  • Any serious illness, life-threatening condition, organ dysfunction, or medical condition compromising safety
  • Active, uncontrolled bacterial, fungal, or viral infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 177 locations

1

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Banner University Medical Center - Tucson

Tucson, Arizona, United States, 85719

Actively Recruiting

3

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States, 85719

Actively Recruiting

4

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Actively Recruiting

5

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States, 94704

Suspended

6

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

7

UCSF Medical Center-Parnassus

San Francisco, California, United States, 94143

Actively Recruiting

8

Miami Cancer Institute

Miami, Florida, United States, 33176

Actively Recruiting

9

Memorial Hospital West

Pembroke Pines, Florida, United States, 33028

Actively Recruiting

10

Phoebe Putney Memorial Hospital

Albany, Georgia, United States, 31701

Actively Recruiting

11

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States, 83706

Actively Recruiting

12

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States, 83712

Actively Recruiting

13

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States, 83605

Actively Recruiting

14

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States, 83814

Actively Recruiting

15

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States, 83619

Actively Recruiting

16

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States, 83642

Actively Recruiting

17

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States, 83687

Actively Recruiting

18

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States, 83687

Actively Recruiting

19

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States, 83854

Actively Recruiting

20

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States, 83864

Actively Recruiting

21

Centralia Oncology Clinic

Centralia, Illinois, United States, 62801

Actively Recruiting

22

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

23

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Actively Recruiting

24

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States, 62526

Actively Recruiting

25

Decatur Memorial Hospital

Decatur, Illinois, United States, 62526

Actively Recruiting

26

Crossroads Cancer Center

Effingham, Illinois, United States, 62401

Actively Recruiting

27

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States, 60201

Actively Recruiting

28

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States, 60026

Actively Recruiting

29

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States, 60035

Actively Recruiting

30

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Actively Recruiting

31

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States, 60451

Actively Recruiting

32

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States, 62269

Actively Recruiting

33

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States, 60462

Actively Recruiting

34

Southern Illinois University School of Medicine

Springfield, Illinois, United States, 62702

Actively Recruiting

35

Springfield Clinic

Springfield, Illinois, United States, 62702

Actively Recruiting

36

Springfield Memorial Hospital

Springfield, Illinois, United States, 62781

Actively Recruiting

37

UChicago Medicine Northwest Indiana

Crown Point, Indiana, United States, 46307

Actively Recruiting

38

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States, 52242

Actively Recruiting

39

University of Kansas Clinical Research Center

Fairway, Kansas, United States, 66205

Actively Recruiting

40

University of Kansas Cancer Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

41

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States, 66211

Actively Recruiting

42

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States, 66205

Actively Recruiting

43

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States, 40536

Actively Recruiting

44

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States, 40202

Actively Recruiting

45

UofL Health Medical Center Northeast

Louisville, Kentucky, United States, 40245

Actively Recruiting

46

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, United States, 70805

Actively Recruiting

47

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, United States, 70808

Actively Recruiting

48

Our Lady of The Lake

Baton Rouge, Louisiana, United States, 70808

Actively Recruiting

49

MaineHealth Maine Medical Center - Portland

Portland, Maine, United States, 04102

Actively Recruiting

50

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States, 04074

Actively Recruiting

51

MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, United States, 04106

Actively Recruiting

52

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889-5600

Actively Recruiting

53

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Actively Recruiting

54

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

55

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States, 01805

Actively Recruiting

56

Lahey Medical Center-Peabody

Peabody, Massachusetts, United States, 01960

Actively Recruiting

57

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States, 48114

Actively Recruiting

58

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States, 48188

Actively Recruiting

59

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States, 48118

Actively Recruiting

60

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States, 48038

Actively Recruiting

61

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

62

Cancer Hematology Centers - Flint

Flint, Michigan, United States, 48503

Actively Recruiting

63

Genesee Hematology Oncology PC

Flint, Michigan, United States, 48503

Suspended

64

Genesys Hurley Cancer Institute

Flint, Michigan, United States, 48503

Actively Recruiting

65

Hurley Medical Center

Flint, Michigan, United States, 48503

Actively Recruiting

66

Allegiance Health

Jackson, Michigan, United States, 49201

Actively Recruiting

67

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States, 48154

Actively Recruiting

68

Henry Ford Medical Center-Columbus

Novi, Michigan, United States, 48377

Actively Recruiting

69

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States, 48341

Actively Recruiting

70

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States, 48322

Actively Recruiting

71

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States, 48197

Actively Recruiting

72

Mercy Hospital

Coon Rapids, Minnesota, United States, 55433

Actively Recruiting

73

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States, 56636

Actively Recruiting

74

Essentia Health Cancer Center

Duluth, Minnesota, United States, 55805

Actively Recruiting

75

Fairview Southdale Hospital

Edina, Minnesota, United States, 55435

Actively Recruiting

76

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States, 55746

Actively Recruiting

77

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

78

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States, 55416

Actively Recruiting

79

Regions Hospital

Saint Paul, Minnesota, United States, 55101

Actively Recruiting

80

United Hospital

Saint Paul, Minnesota, United States, 55102

Actively Recruiting

81

Essentia Health Sandstone

Sandstone, Minnesota, United States, 55072

Actively Recruiting

82

Essentia Health Virginia Clinic

Virginia, Minnesota, United States, 55792

Actively Recruiting

83

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, United States, 39705

Actively Recruiting

84

Baptist Cancer Center-Grenada

Grenada, Mississippi, United States, 38901

Actively Recruiting

85

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, United States, 38652

Actively Recruiting

86

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, United States, 38655

Actively Recruiting

87

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States, 38671

Actively Recruiting

88

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States, 63376

Actively Recruiting

89

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States, 63141

Actively Recruiting

90

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

91

Siteman Cancer Center-South County

St Louis, Missouri, United States, 63129

Actively Recruiting

92

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States, 63136

Actively Recruiting

93

Community Hospital of Anaconda

Anaconda, Montana, United States, 59711

Actively Recruiting

94

Billings Clinic Cancer Center

Billings, Montana, United States, 59101

Actively Recruiting

95

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States, 59715

Actively Recruiting

96

Benefis Sletten Cancer Institute

Great Falls, Montana, United States, 59405

Actively Recruiting

97

Logan Health Medical Center

Kalispell, Montana, United States, 59901

Actively Recruiting

98

Community Medical Center

Missoula, Montana, United States, 59804

Actively Recruiting

99

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States, 68123

Actively Recruiting

100

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States, 68118

Actively Recruiting

101

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

102

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States, 89102

Suspended

103

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States, 89183

Suspended

104

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

105

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

106

Saint Barnabas Medical Center

Livingston, New Jersey, United States, 07039

Actively Recruiting

107

Monmouth Medical Center

Long Branch, New Jersey, United States, 07740

Actively Recruiting

108

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States, 07748

Actively Recruiting

109

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

Actively Recruiting

110

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

Actively Recruiting

111

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, United States, 07652

Actively Recruiting

112

Valley Health System Ridgewood Campus

Ridgewood, New Jersey, United States, 07450

Actively Recruiting

113

Community Medical Center

Toms River, New Jersey, United States, 08755

Actively Recruiting

114

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

115

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

116

Memorial Sloan Kettering Commack

Commack, New York, United States, 11725

Actively Recruiting

117

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

118

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

119

University of Rochester

Rochester, New York, United States, 14642

Actively Recruiting

120

Stony Brook University Medical Center

Stony Brook, New York, United States, 11794

Actively Recruiting

121

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States, 10467

Actively Recruiting

122

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

Actively Recruiting

123

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States, 28203

Actively Recruiting

124

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States, 28204

Actively Recruiting

125

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

126

East Carolina University

Greenville, North Carolina, United States, 27834

Actively Recruiting

127

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

128

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

129

Case Western Reserve University

Cleveland, Ohio, United States, 44106

Actively Recruiting

130

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

131

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States, 97914

Actively Recruiting

132

Providence Portland Medical Center

Portland, Oregon, United States, 97213

Actively Recruiting

133

Providence Saint Vincent Medical Center

Portland, Oregon, United States, 97225

Actively Recruiting

134

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States, 18103

Actively Recruiting

135

Geisinger Medical Center

Danville, Pennsylvania, United States, 17822

Actively Recruiting

136

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States, 17033-0850

Actively Recruiting

137

Lewistown Hospital

Lewistown, Pennsylvania, United States, 17044

Actively Recruiting

138

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

139

Reading Hospital

West Reading, Pennsylvania, United States, 19611

Actively Recruiting

140

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States, 18711

Actively Recruiting

141

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States, 29316

Actively Recruiting

142

Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States, 29640

Actively Recruiting

143

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States, 29605

Actively Recruiting

144

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States, 29605

Actively Recruiting

145

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States, 29615

Actively Recruiting

146

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States, 29650

Actively Recruiting

147

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States, 29672

Actively Recruiting

148

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, United States, 38017

Actively Recruiting

149

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States, 38120

Actively Recruiting

150

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

151

Ben Taub General Hospital

Houston, Texas, United States, 77030

Actively Recruiting

152

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

153

University of Vermont Medical Center

Burlington, Vermont, United States, 05401

Actively Recruiting

154

University of Vermont and State Agricultural College

Burlington, Vermont, United States, 05405

Actively Recruiting

155

University of Virginia Cancer Center

Charlottesville, Virginia, United States, 22908

Actively Recruiting

156

Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

Actively Recruiting

157

Inova Fairfax Hospital

Falls Church, Virginia, United States, 22042

Actively Recruiting

158

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States, 98026

Actively Recruiting

159

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States, 98029

Actively Recruiting

160

Swedish Medical Center-First Hill

Seattle, Washington, United States, 98122

Actively Recruiting

161

Duluth Clinic Ashland

Ashland, Wisconsin, United States, 54806

Actively Recruiting

162

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States, 54301

Actively Recruiting

163

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States, 54303

Actively Recruiting

164

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States, 54601

Actively Recruiting

165

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

166

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States, 54482

Actively Recruiting

167

Marshfield Medical Center - Weston

Weston, Wisconsin, United States, 54476

Actively Recruiting

168

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

Actively Recruiting

169

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

170

CancerCare Manitoba

Winnipeg, Manitoba, Canada, R3E 0V9

Actively Recruiting

171

QEII Health Sciences Centre/Nova Scotia Health Authority

Halifax, Nova Scotia, Canada, B3H 2Y9

Actively Recruiting

172

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada, L8V 5C2

Actively Recruiting

173

CSSS Champlain-Charles Le Moyne

Greenfield Park, Quebec, Canada, J4V 2H1

Actively Recruiting

174

CIUSSSEMTL-Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada, H1T 2M4

Actively Recruiting

175

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

176

Centro Comprensivo de Cancer de UPR

San Juan, Puerto Rico, 00927

Actively Recruiting

177

San Juan City Hospital

San Juan, Puerto Rico, 00936

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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