Clinical trials: Myelodysplastic Neoplasm
Neoplasms
Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
This study will evaluate the safety, tolerability, and clinical activity of GSK3326595 in participants with relapsed and refractory MDS, chronic myelomonocytic leukemia (CMML), and AML.
- Trial name
- NCT03614728
- Testing
- GSK3326595, 5-Azacitidine
- Where
- 8 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Paroxysmal Nocturnal Hemoglobinuria
A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works
This study is researching an experimental treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH).
- Trial name
- ACCESS-EXT (NCT05744921)
- Testing
- Pozelimab, Cemdisiran
- Where
- 48 sites in Brazil, Canada and 18 more
- Volunteers
- 202 people
- Sponsor
- Regeneron Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Treating Paroxysmal Nocturnal Haemoglobinuria Patients With rVA576
rVA576 for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).
- Trial name
- CAPSTONE (NCT03588026)
- Testing
- rVA576, Standard of care (SOC)
- Where
- 3 sites in Kazakhstan, Lithuania and 1 more
- Volunteers
- 9 people
- Sponsor
- AKARI Therapeutics
Hematological Neoplasms, Non-Hodgkin's Lymphoma
Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies
This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension…
- Conditions
- Hematological Neoplasms, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Lymphoma
- Trial name
- NCT02223052
- Testing
- CC-486, Vidaza
- Where
- 10 sites in United States
- Volunteers
- 89 people
- Sponsor
- Celgene
Leukemia, Myelodysplastic Syndromes
Study of Matched Unrelated Donor T Cell Infusion for Hematologic Malignancies After Allo-HSCT
This is a Phase I, multicenter, open-label, non-randomized study of matched unrelated donor BPX-501 T cell infusion in adult subjects with hematological malignancies presenting with recurrent disease minimal residual disease…
- Conditions
- Leukemia, Myelodysplastic Syndromes, Lymphomas, Multiple Myeloma
- Trial name
- NCT02786485
- Testing
- rivogenlecleucel, Rimiducid
- Sponsor
- Bellicum Pharmaceuticals
Leukemia, Myeloid, Acute, Myelodysplastic Neoplasms
A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
The purpose of Part 1 (Dose Escalation) of the study is to assess the safety and tolerability, and to identify the recommended Phase 2 dose[s] (RP2D[s]) in participants with relapsed or refractory (R/R) acute myeloid leukemia…
- Trial name
- NCT06618001
- Testing
- JNJ-89853413
- Where
- 9 sites in Canada, Spain and 1 more
- Volunteers
- 64 people
- Sponsor
- Janssen Research & Development, LLC
Paroxysmal Nocturnal Hemoglobinuria
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants.
- Trial name
- COMMODORE 1 (NCT04432584)
- Testing
- Crovalimab, Eculizumab
- Where
- 80 sites in United States, Belgium and 22 more
- Volunteers
- 190 people
- Sponsor
- Hoffmann-La Roche
AML, Adult Recurrent, MDS
A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)
A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/refractory, High-risk…
- Trial name
- NCT05829226
- Testing
- LYT-200, Venetoclax, Azacitidine
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- PureTech
Higher-risk Myelodysplastic Syndrome
Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of lisaftoclax (APG-2575) combined with azacitidine (AZA) vs.
- Trial name
- NCT06641414
- Testing
- Lisaftoclax (APG-2575), Azacitidine Injection
- Where
- 155 sites in United States, Australia and 16 more
- Volunteers
- 490 people
- Sponsor
- Ascentage Pharma Group Inc.
Paroxysmal Nocturnal Hemoglobinuria
Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
This is an extension study for patients who have completed a prior P10-LP005-02 clinical study. The aim of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of LP-005 injection in adult patients with…
- Trial name
- NCT07266155
- Testing
- LP-005 Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Longbio Pharma
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 Refractory, Myelodysplastic Syndrome Acute Myeloid Leukemia
A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS
This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute…
- Conditions
- Acute Myeloid Leukemia Refractory, Myelodysplastic Syndrome Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts, Acute Myeloid Leukemia, in Relapse
- Trial name
- NCT06372717
- Testing
- APL-4098, Azacitidine and APL-4098, Azacitidine and Venetoclax and APL-4098
- Where
- 9 sites in Australia, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Apollo Therapeutics Ltd
Myelodysplastic Syndromes
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes
This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
- Trial name
- NCT06091267
- Testing
- IV Decitabine, Decitabine and cedazuridine, only Decitabine and cedazuridine
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Otsuka Beijing Research Institute
Solid Tumor, Adult, Acute Myeloid Leukemia
A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
A Phase I, Open Label, Dose-Escalation, First in Human (FIH) study evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR103 Calcium in patients with relapsed advanced malignancies (BHARAT-1).
- Conditions
- Solid Tumor, Adult, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non Hodgkin Lymphoma
- Trial name
- BHARAT-1 (NCT05607199)
- Testing
- AUR103
- Where
- 5 sites in India
- Volunteers
- 27 people
- Sponsor
- Aurigene Discovery Technologies Limited
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With Myelodysplasia-Related Changes
VYxeoS Liposomal Italian Observational Study iN the Real Practice
The study is a prospective, single-arm, non-experimental, observational study in patients in Italy with Acute Myeloid Leukaemia (AML) with myelodysplastic-related changes or therapy related AML initiating treatment with JZP351…
- Conditions
- Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia
- Trial name
- VYSION (NCT06143839)
- Testing
- Vyxeos liposomal
- Where
- 24 sites in Italy
- Volunteers
- 113 people
- Sponsor
- Jazz Pharmaceuticals
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic…
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia, Acute Lymphoblastic Leukemia
- Trial name
- NCT03802695
- Testing
- OrcaGraft (Orca-Q)
- Where
- 12 sites in United States
- Volunteers
- 300 people
- Sponsor
- Orca Biosystems, Inc.
Paroxysmal Nocturnal Hemoglobinuria, PNH
A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy
A study of the efficacy and safety of VSA012 Injection compared to eculizumab for 24 weeks in patients with PNH.
- Trial name
- NCT07816237
- Testing
- VSA012, Eculizumab (Soliris®)
- Where
- 14 sites in China
- Volunteers
- 70 people
- Sponsor
- Bisirna Therapeutics (Suzhou) Co., Ltd.
Myelodysplastic Syndromes
Extension Study to Evaluate Long-Term Effects of Luspatercept in Patients With Myelodysplastic Syndromes (MDS) (A536-05/MK-6143-003)
This study is an open-label extension study for participants previously enrolled in study MK-6143-001 (formerly called A536-03, ClinicalTrials.gov Identifier NCT01749514), to evaluate the long-term safety and tolerability of…
- Trial name
- NCT02268383
- Testing
- Luspatercept
- Where
- Germany
- Volunteers
- 75 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of RO6870810/TEN-010 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndrome
RO6870810 (formerly TEN-010) is a small molecule, bromodomain and extra-terminal (BET) bromodomain inhibitor. This study is designed to characterize the safety, tolerability, and pharmacokinetics of RO6870810 monotherapy in…
- Trial name
- NCT02308761
- Testing
- RO6870810
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
Myelodysplastic Syndrome
Long Term Safety Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study
This is an extension study study to investigate long term safety of SyB L-1101 when administered intravenously every 4 weeks to the patients who have completed 8 cycles in the study 2011005 whose purpose is to investigate…
- Trial name
- NCT02000154
- Testing
- SyB L-1101
- Where
- 9 sites in Japan
- Volunteers
- 1 people
- Sponsor
- SymBio Pharmaceuticals