Informations générales (source: ClinicalTrials.gov)
A Phase 1/2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Interventional
Phase 1/Phase 2
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
mai 2021
mai 2028
29 août 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Armand Trousseau-La Roche Guyon | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie - 33604 - Pessac - France | Contact (sur clinicalTrials) | ||||
| CHRU Nancy Brabois - 54511 - Vandoeuvre les Nancy - France | Contact (sur clinicalTrials) | ||||
| CHU Bretonneau - 37044 - Tours cedex - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes hotel Dieu - 44093 - Nantes Cedex 1 - France | Contact (sur clinicalTrials) | ||||
| CHU Lyon Sud - 69310 - Pierre Benite - France | Contact (sur clinicalTrials) | ||||
| Hopital Jean Minjoz - 25000 - Besancon - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie Strasbourg Europe ICANS - 67200 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Institut Universitaire du Cancer Toulouse Oncopole - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
Phase 1:
- Age 2 years and above (pediatric cohort only), all other cohorts 18 years and above
- Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for,
available therapeutic options
- 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; For adult participants, estimated or measured glomerular
filtration rate greater than equal (>=) 30 milliliter per minute (mL/min) per four
variable MDRD equation. For pediatric participants an estimated or measured
glomerular filtration rate >40 mL/min per the CKiD (Chronic Kidney Disease in
Children) Schwartz formula
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2.
Pediatric 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
Phase 1:
- Age 2 years and above (pediatric cohort only), all other cohorts 18 years and above
- Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for,
available therapeutic options
- 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; For adult participants, estimated or measured glomerular
filtration rate greater than equal (>=) 30 milliliter per minute (mL/min) per four
variable MDRD equation. For pediatric participants an estimated or measured
glomerular filtration rate >40 mL/min per the CKiD (Chronic Kidney Disease in
Children) Schwartz formula
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2.
Pediatric 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
- 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)