Leukemia, Myeloid, Acute Clinical Trial
Official title:
An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous BI 6727 as Monotherapy or in Combination With Subcutaneous Cytarabine in Patients With Acute Myeloid Leukaemia
The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, BI 6727 will be investigated as monotherapy and in combination with low dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients. In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C monotherapy will be investigated to explore the efficacy of the combination schedule in comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible for intensive treatment.
n/a
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 |
NCT00916045 -
Pilot Study of Unrelated Cord Blood Transplantation
|
Phase 2 | |
Terminated |
NCT00957580 -
Trial of Pimasertib in Hematological Malignancies
|
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 | |
Recruiting |
NCT05453903 -
A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
|
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 |