Clinical trials: Refractory AML
Hematologic Neoplasms
Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation
The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are: To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle…
- Trial name
- NCT01915498
- Testing
- Enasidenib
- Where
- 24 sites in United States, France
- Volunteers
- 345 people
- Sponsor
- Celgene
Relapsed or Refractory Multiple Myeloma (RRMM), Diffuse Large B Cell Lymphoma (DLBCL)
GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies
The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety.
- Conditions
- Relapsed or Refractory Multiple Myeloma (RRMM), Diffuse Large B Cell Lymphoma (DLBCL), Acute Myeloid Leukemia (AML)
- Trial name
- NCT04824794
- Testing
- GEN3014, Daratumumab
- Where
- 52 sites in United States, Australia and 18 more
- Volunteers
- 130 people
- Sponsor
- Genmab
Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory Chronic Myelomonocytic Leukemia
A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and recommended Phase 2 dose (RP2D) of MK-0482. There are 2 parts of this study.
- Trial name
- NCT05038800
- Testing
- MK-0482
- Where
- 5 sites in United States, Israel and 1 more
- Volunteers
- 13 people
- Sponsor
- Merck Sharp & Dohme LLC
Acute Myeloid Leukemia
Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)
The primary objectives of this study are to evaluate the safety and tolerability of emerfetamab in adults with relapsed/refractory acute myeloid leukemia (AML) and to estimate the maximum tolerated dose (MTD) and/or a…
- Trial name
- NCT03224819
- Testing
- Emerfetamab
- Where
- 7 sites in United States, Australia and 1 more
- Volunteers
- 46 people
- Sponsor
- Amgen
Leukemia, Acute Myeloid (AML)
A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who were refractory to or had relapsed after first-line…
- Trial name
- NCT02421939
- Testing
- gilteritinib, LoDAC (Low Dose Cytarabine), Azacitidine
- Where
- 126 sites in United States, Belgium and 12 more
- Volunteers
- 371 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)
The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and…
- Trial name
- NCT03730012
- Testing
- gilteritinib, atezolizumab
- Where
- 12 sites in United States
- Volunteers
- 11 people
- Sponsor
- Astellas Pharma Global Development, Inc.
ECG, Pharmacokinetics
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory…
- Conditions
- ECG, Pharmacokinetics, Safety
- Trial name
- NCT03727750
- Testing
- Gemtuzumab Ozogamicin
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Thrombocytopaenia
A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia
This was a worldwide, three-part (Part 1: open-label, Part 2: randomized, double-blind, Part 3: extension), multi-center study to evaluate the effect of eltrombopag in subjects with myelodysplastic syndromes (MDS) or acute…
- Trial name
- ASPIRE (NCT01440374)
- Testing
- eltrombopag
- Where
- 120 sites in United States, Argentina and 20 more
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory Chronic Myelomonocytic Leukemia
A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms
This is an open-label, non-randomized, Phase 1 study to determine the safety and tolerability of NC525. This study will also assess the clinical benefit in subjects with advanced myeloid neoplasms.
- Conditions
- Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory Chronic Myelomonocytic Leukemia, Relapsed or Refractory Myelodysplastic Syndrome
- Trial name
- NCT05787496
- Testing
- NC525
- Where
- 11 sites in United States
- Volunteers
- 28 people
- Sponsor
- NextCure, Inc.
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML
The proposed study is designed to combine crenolanib with standard salvage chemotherapy to treat patients with R/R AML irrespective the FLT3 status.
- Trial name
- NCT02626338
- Testing
- Crenolanib, Mitoxantrone, Cytarabine
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Arog Pharmaceuticals, Inc.
Neoplasms
A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies
This is an open-label repeat dose, multicenter, 2-part study to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for GSK525762 given once-daily (QD) orally.
- Trial name
- NCT01943851
- Testing
- GSK525762
- Where
- 15 sites in United States, Australia and 3 more
- Volunteers
- 111 people
- Sponsor
- GlaxoSmithKline
Hematologic Malignancy, Acute Myeloid Leukemia
Entospletinib (ENTO) as Monotherapy and in Combination With Chemotherapy in Japanese Adults
The primary objective of this study is to evaluate the safety and tolerability of entospletinib (ENTO) monotherapy and in combination with chemotherapy in Japanese participants.
- Trial name
- Japanese AML (NCT03135028)
- Testing
- Entospletinib, Daunorubicin, Cytarabine
- Where
- 6 sites in Japan
- Volunteers
- 9 people
- Sponsor
- Gilead Sciences
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)
A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
The purpose of the phase 1 portion (dose escalation) of the study was to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in…
- Trial name
- NCT04240002
- Testing
- gilteritinib, fludarabine, cytarabine
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 9 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome
A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)
The purpose of this study was to evaluate the safety and tolerability and to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of ASP7517.
- Trial name
- NCT04079296
- Testing
- ASP7517
- Where
- 16 sites in United States, Japan
- Volunteers
- 43 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
IGF-MTX Conjugate in the Treatment of Myelodysplastic Syndrome
The primary objective of this study is to determine the safety and tolerability of utilizing the insulin-like growth factor-1-methotrexate conjugate, 765IGF-MTX for the treatment of advanced, previously treated myelodysplastic…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Anemia, Refractory, With Excess of Blasts
- Trial name
- NCT03175978
- Testing
- IGF/MTX
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- IGF Oncology, LLC
Acute Myeloid Leukemia
Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia
The goal of this clinical study is to learn more about the safety and dosing of the study drug, KITE-222, in participants with relapsed/refractory (r/r) acute myeloid leukemia (AML).
- Trial name
- NCT04789408
- Testing
- Cyclophosphamide, Fludarabine, KITE-222
- Where
- 9 sites in United States, France
- Volunteers
- 15 people
- Sponsor
- Kite, A Gilead Company
AML
(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive
The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication…
- Trial name
- NCT02039726
- Testing
- Quizartinib, Salvage Chemotherapy
- Where
- 131 sites in United States, Australia and 17 more
- Volunteers
- 367 people
- Sponsor
- Daiichi Sankyo
Relapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations
This is a Phase II open label study of crenolanib besylate. This study will enroll subjects with relapsed or refractory AML with FLT3 activating mutations. Prior treatment with other FLT3 TKIs is allowed.
- Trial name
- NCT01522469
- Testing
- Crenolanib Besylate (CP-868,596-26)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Arog Pharmaceuticals, Inc.
GVHD, Adult Acute Myeloid Leukemia
Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.
- Conditions
- GVHD, Adult Acute Myeloid Leukemia, Adult Acute Lymphoid Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT01295710
- Testing
- US-ATG-F
- Where
- 28 sites in United States, Australia
- Volunteers
- 260 people
- Sponsor
- Neovii Biotech
Acute Myeloid Leukemia (AML)
Study of Alvocidib in Patients With Relapsed/Refractory AML Following Treatment With Venetoclax Combination Therapy
This study will evaluate the safety and efficacy of alvocidib in patients with AML who have either relapsed from or are refractory to venetoclax in combination with azacytidine or decitabine.
- Trial name
- NCT03969420
- Testing
- Alvocidib (flavopiridol) and cytarabine (Ara-C), Alvocidib (flavopiridol)
- Where
- 18 sites in United States
- Volunteers
- 11 people
- Sponsor
- Sumitomo Pharma America, Inc.