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My Saved Trials

A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia

Last Updated   May 14, 2025

Want to learn how to participate in this trial?

CR108998

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    12+ years
  • Phase
    phase 1
    1
  • Sites
    82 Sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of bleximenib in phase 1 (Part 1 [Dose Escalation] and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.

CONDITIONS

  • Acute Leukemias
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia

ELIGIBILITY


Inclusion Criteria:

Phase 1:

* Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
* Participants greater than or equal (>=)12 and less than (<) 18 years of age are only eligible for the Phase 1 adolescent cohort
* Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations

Phase: 2

* Participants greater than 18 years are eligible
* Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease
* AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only

For Both Phase 1 and 2:

* Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count less than or equal to (<=) 20*10^9/liter (L) and (b) renal function; Estimated or measured glomerular filtration rate greater than or equal to (>=) 50 milliliter per minute (mL/min) per four variable modified diet in renal disease (MDRD) equation
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Adolescent participants only: Performance status >=70 by Lansky scale (for participants less than [<]16 years of age) or >=70 Karnofsky scale (for participants >=16 years of age)
* A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
* Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment


Exclusion Criteria:

* Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria
* Active central nervous system (CNS) disease
* Prior solid organ transplantation
* QTc according to Fridericia's formula (QTcF) for males >= 450 millisecond (msec) or for females >= 470 msec. Participants with a family history of Long QT syndrome are excluded
* Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant <=3 months before the first dose of study treatment; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion <=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses <=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
* Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)


Inclusion Criteria:

Phase 1:

* Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
* Participants greater than or equal (>=)12 and less than (<) 18 years of age are only eligible for the Phase 1 adolescent cohor

More...

DETAILS

LOCATIONS

Locations in:
United States, Australia, France, Spain, United Kingdom, Canada, China, Israel, Japan, South Korea, Taiwan, Brazil
Country (12) City or Province (82) Status
United States Duarte City of Hope
RECRUITING
United States Orange University of California Irvine Medical Center
COMPLETED
United States San Francisco University of California San Francisco
RECRUITING
United States Louisville Norton Cancer Institute
COMPLETED
United States Boston Massachusetts General Hospital
RECRUITING
United States Boston Dana Farber Cancer Institute
RECRUITING
United States New York NYU Langone Medical Center
RECRUITING
United States Houston MD Anderson
RECRUITING
United States Milwaukee Medical College of WI at Froedtert
RECRUITING
Australia Clayton Monash Medical Centre
RECRUITING
Australia Perth Royal Perth Hospital
RECRUITING
Australia Southport Gold Coast University Hospital
RECRUITING
France Marseille Institut Paoli Calmettes
RECRUITING
France Nantes Cedex 1 CHU de Nantes hotel Dieu
RECRUITING
France Paris Hopital trousseau- APHP
RECRUITING
France Pessac Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
COMPLETED
France Toulouse Institut Universitaire du Cancer Toulouse Oncopole
RECRUITING
France Tours cedex CHU Bretonneau
RECRUITING
Spain Barcelona Hosp Clinic de Barcelona
RECRUITING
Spain Madrid Hosp Univ Fund Jimenez Diaz
RECRUITING
Spain Pamplona Clinica Univ. de Navarra
RECRUITING
United Kingdom Manchester The Christie Nhs Foundation Trust
RECRUITING
United Kingdom Oxfordshire Oxford University Hospitals NHS Trust
RECRUITING
United States Grand Rapids Start Midwest
RECRUITING
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
United States Indianapolis St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
RECRUITING
United States Detroit Karmanos Cancer Institute
RECRUITING
United States Albuquerque University of New Mexico
RECRUITING
United States Bronx Montefiore Medical Center
RECRUITING
United States Portland Oregon Health And Science University
RECRUITING
United States Providence Maine Health
RECRUITING
United States Knoxville University of Tennessee Medical Center
RECRUITING
United States Dallas Baylor University Medical Center
RECRUITING
United States Houston Houston Methodist Hospital
RECRUITING
United States San Antonio San Antonio Methodist TX Transplant Physicians Group
RECRUITING
United States Richmond Virginia Commonwealth University
RECRUITING
United States Seattle Swedish Cancer Institute
RECRUITING
Canada Vancouver Vancouver Coastal Health
RECRUITING
Canada Toronto Princess Margaret Cancer Centre University Health Network
RECRUITING
China Beijing Peking University First Hospital
RECRUITING
China Changchun The First Hospital of Jilin University
RECRUITING
China Chengdu West China Hospital Si Chuan University
RECRUITING
China Guangzhou Nanfang Hospital of Southern Medical Hospital
RECRUITING
China Hang Zhou First Affiliated Hospital Medical School of Zhejiang University
RECRUITING
China Nanchang The First Affiliated Hospital of NanChang University
RECRUITING
China Nanjing Zhongda Hospital Southeast University
RECRUITING
China Tian Jin Institute of Hematology and Blood Diseases Hospital
RECRUITING
China Wenzhou The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
China Wuhan Union Hospital Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
China Zheng Zhou Shi Henan Cancer Hospital
RECRUITING
France Besancon Hopital Jean Minjoz
RECRUITING
France Paris Hopital Saint Louis
RECRUITING
France Pierre Benite CHU Lyon Sud
RECRUITING
France Strasbourg Institut de Cancerologie Strasbourg Europe ICANS
RECRUITING
France Vandoeuvre les Nancy CHRU Nancy Brabois
RECRUITING
France Villejuif Gustave Roussy
RECRUITING
Israel Haifa Carmel Medical Center
RECRUITING
Israel Jerusalem Hadassah University Hospita Ein Kerem
RECRUITING
Israel Ramat Gan Sheba Medical Center
RECRUITING
Israel Tel Aviv Yafo Tel Aviv Sourasky Medical Center
RECRUITING
Japan Fukushima Fukushima Medical University Hospital
RECRUITING
Japan Nagoya Nagoya University Hospital
RECRUITING
Japan Sapporo Hokkaido University Hospital
RECRUITING
Japan Tokyo NTT Medical Center Tokyo
RECRUITING
Japan Yoshida University of Fukui Hospital
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
South Korea Seoul Asan Medical Center
RECRUITING
South Korea Seoul Samsung Medical Center
RECRUITING
Spain Madrid Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
Spain Salamanca Hosp Clinico Univ de Salamanca
RECRUITING
Spain Sevilla Hosp. Virgen Del Rocio
RECRUITING
Spain Valencia Hosp. Clinico Univ. de Valencia
RECRUITING
Taiwan Taichung China Medical University Hospital
RECRUITING
Taiwan Tainan National Cheng Kung University Hospital
RECRUITING
Taiwan Taipei National Taiwan University Hospital
RECRUITING
United Kingdom London Guys and St Thomas NHS Foundation Trust
RECRUITING
United Kingdom Plymouth University Hospitals Plymouth NHS Trust
RECRUITING
United States Chicago University of Chicago
RECRUITING
United States Philadelphia Fox Chase Cancer Center
RECRUITING
Brazil Sao Paulo Instituto D Or de Pesquisa e Ensino IDOR
RECRUITING
Canada Montreal Hopital Maisonneuve Rosemont
RECRUITING
China Jinan Qilu Hospital of Shandong University
RECRUITING
Show More
Geo Locations

34.13945, -117.97729

33.78779, -117.85311

37.77493, -122.41942

38.25424, -85.75941

42.35843, -71.05977

42.35843, -71.05977

40.71427, -74.00597

29.76328, -95.36327

43.0389, -87.90647

-37.91667, 145.11667

-31.95224, 115.8614

-27.96724, 153.39796

43.29551, 5.38958

47.21725, -1.55336

48.85341, 2.3488

44.81011, -0.64129

43.60426, 1.44367

47.38333, 0.68333

41.38879, 2.15899

40.4165, -3.70256

42.81687, -1.64323

53.48095, -2.23743

51.750337, -1.2146896

42.96336, -85.66809

41.38879, 2.15899

39.76838, -86.15804

42.33143, -83.04575

35.08449, -106.65114

40.84985, -73.86641

45.52345, -122.67621

41.82399, -71.41283

35.96064, -83.92074

32.78306, -96.80667

29.76328, -95.36327

29.42412, -98.49363

37.55376, -77.46026

47.60621, -122.33207

49.24966, -123.11934

43.70011, -79.4163

39.9075, 116.39723

43.88, 125.32278

30.66667, 104.06667

23.11667, 113.25

30.2473999, 120.17766

28.68396, 115.85306

32.06167, 118.77778

39.1251999, 117.191

27.99942, 120.66682

30.58333, 114.26667

34.7689999, 113.688

47.24878, 6.01815

48.85341, 2.3488

45.7009, 4.82511

48.58392, 7.74553

48.65, 6.18333

48.7939, 2.35992

32.81841, 34.9885

31.76904, 35.21633

32.08227, 34.81065

32.08088, 34.78057

37.75, 140.46667

35.18147, 136.90641

43.06667, 141.35

35.6895, 139.69171

36.1091582, 136.2922

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

40.4165, -3.70256

40.96882, -5.66388

37.38283, -5.97317

39.46975, -0.37739

24.1469, 120.6839

22.99083, 120.21333

25.04776, 121.53185

51.50853, -0.12574

50.37153, -4.14305

41.85003, -87.65005

39.95233, -75.16379

-23.5475, -46.63611

45.50884, -73.58781

36.66833, 116.99722

x
50

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10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

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