A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia
Last Updated March 11, 2025
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CR108998
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 11 -
Sites
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 cohor
DETAILS
LOCATIONS
Locations in:
United States, Australia, France, Spain, United Kingdom, Canada, China, Israel, Japan, South Korea, Taiwan
| Country (11) | City or Province (77) | 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
|
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
x
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10
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5
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Corresponds to individual site.