Leukemia, Myeloid, Acute Clinical Trial
Official title:
A Phase 1b Study of JNJ-75276617 in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of JNJ-75276617 in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of JNJ-75276617 in combination with AML directed therapies at the RP2D(s) (dose expansion).
AML is a heterogenous disease characterized by uncontrolled clonal expansion of hematopoietic progenitor cells (myeloid blasts) in the peripheral blood, bone marrow and other tissues and is the most common type of acute leukemia in adults. JNJ-75276617 is an orally bioavailable, potent, and selective protein-protein interaction inhibitor of the binding between histone-lysine N-methyltransferase 2A ([KMT2A], also called mixed-lineage leukemia 1 [MLL1]; wild-type and fusion) and menin, with activity in leukemic cell lines and primary leukemia patient or patient-derived samples with either KMT2A alterations including gene rearrangements (KMT2A-r), duplications, and amplification, or nucleophosmin 1 gene (NPM1) alterations. The aim of this study is to determine the RP2D(s), safety, pharmacokinetic, pharmacodynamic and preliminary clinical activity of JNJ-75276617 in combination with AML directed therapies for adult participants with relapsed/refractory or newly diagnosed AML with NPM1 or KMT2A gene alterations and will include dose selection and subsequent combination specific dose expansion. The total study duration will be up to 2 years. Safety evaluations include adverse events (AE) monitoring, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements, physical examination findings, and eastern cooperative oncology group (ECOG) performance status score. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05319587 -
Study of Liposomal Annamycin in Combination With Cytarabine for the Treatment of Subjects With Acute Myeloid Leukemia (AML)
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04090736 -
Study to Compare Azacitidine Plus Pevonedistat Versus Azacitidine in Patients With Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy
|
Phase 3 | |
| Completed |
NCT01617226 -
Randomised Study of Azacitidine Versus Azacitidine With Vorinostat in Patients With AML or High Risk MDS
|
Phase 2 | |
| Terminated |
NCT00957580 -
Trial of Pimasertib in Hematological Malignancies
|
Phase 2 | |
| Terminated |
NCT00916045 -
Pilot Study of Unrelated Cord Blood Transplantation
|
Phase 2 | |
| Completed |
NCT00640796 -
Pilot Study of Expanded, Donor Natural Killer Cell Infusions for Refractory Non-B Lineage Hematologic Malignancies and Solid Tumors
|
Phase 1 | |
| Completed |
NCT00458250 -
Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H
|
Phase 1 | |
| Active, not recruiting |
NCT05424380 -
A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS
|
Phase 1 | |
| Completed |
NCT01690624 -
BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients in Complete Remission With High Risk to Relapse
|
Phase 1 | |
| Recruiting |
NCT05471700 -
Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05016063 -
Dual CD33-CLL1-CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
|
Early Phase 1 | |
| Not yet recruiting |
NCT04450784 -
ObServatory Children Acute RElated Therapy Leukemia
|
||
| Recruiting |
NCT04265963 -
CD123-Targeted CAR-T Cell Therapy for Relapsed/Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Terminated |
NCT04968860 -
Oral Health Condition and Quality of Life in Children With Leukemia
|
||
| Recruiting |
NCT03793517 -
Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT
|
Phase 2/Phase 3 | |
| Terminated |
NCT02841540 -
A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes
|
Phase 1 | |
| Completed |
NCT03720366 -
A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients
|
Phase 1 | |
| Withdrawn |
NCT04230564 -
Acute Myeloid Leukemia Real World Treatment Patterns
|
||
| Terminated |
NCT03761069 -
Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias
|
Phase 1 | |
| Completed |
NCT01835587 -
Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
|
Phase 1/Phase 2 |