Clinical trials: Myelodysplastic Neoplasm
- Condition Myelodysplastic Neoplasm
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Paroxysmal Nocturnal Hemoglobinuria (PNH)
A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH
This study will be the initial exploration of pegcetacoplan in patients with PNH. The assessments of the safety, tolerability, PK, and PD following administration of single and multiples doses of pegcetacoplan will guide…
- Trial name
- NCT02264639
- Testing
- Pegcetacoplan
- Where
- 7 sites in United States
- Volunteers
- 9 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors
A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy.
- Trial name
- COMMODORE 2 (NCT04434092)
- Testing
- Crovalimab, Eculizumab
- Where
- 63 sites in Argentina, Brazil and 21 more
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
Leukemia, Myeloid, Acute
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
This is a Phase 1, open label, two-part study to determine recommended phase 2 dose (RP2D) and schedule of GSK3745417 administration in participants with relapsed/refractory AML or HR-MDS.
- Trial name
- NCT05424380
- Testing
- GSK3745417
- Where
- 10 sites in Canada, Germany and 3 more
- Volunteers
- 18 people
- Sponsor
- GlaxoSmithKline
Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL)
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute…
- Conditions
- Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML)
- Trial name
- NCT02730299
- Testing
- NiCord® (omidubicel), Cord Blood Unit
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 125 people
- Sponsor
- Gamida Cell ltd
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
The purpose of this study was to determine the safety and efficacy of ACH-0144471 (also known as danicopan and ALXN2040) in currently untreated participants with PNH.
- Trial name
- NCT03053102
- Testing
- Danicopan
- Where
- 5 sites in Italy, New Zealand and 2 more
- Volunteers
- 10 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Myelodysplastic Syndromes
Trial of Volasertib With or Without Azacitidine in Patients With Myelodysplastic Syndromes
The objectives of this trial are to evaluate the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics and preliminary efficacy of volasertib in two dosing schedules of intravenous volasertib as monotherapy or in…
- Trial name
- NCT02721875
- Testing
- Volasertib, Azacitidine
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- Boehringer Ingelheim
Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML)
Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies
Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second, Unmanipulated CBU in Patients with Hematological Malignancies
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS), Non-Hodgkin's Lymphoma
- Trial name
- NCT01221857
- Testing
- NiCord®
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Gamida Cell ltd
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
Myelodysplastic Syndrome, Iron Overload
Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients
The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.
- Trial name
- NCT00110266
- Testing
- Deferasirox
- Where
- 48 sites in United States, Canada
- Volunteers
- 176 people
- Sponsor
- Novartis Pharmaceuticals
Tumor Lysis Syndrome, Cancer
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
This is a randomized, multi-center, open-label, parallel group study with three arms: Rasburicase alone Rasburicase followed by Allopurinol Allopurinol alone The primary objective is to compare the adequacy of control of plasma…
- Conditions
- Tumor Lysis Syndrome, Cancer, Hyperuricemia
- Trial name
- NCT00230178
- Testing
- Rasburicase (SR29142), Allopurinol
- Where
- 15 sites in United States
- Volunteers
- 280 people
- Sponsor
- Sanofi
Leukemia, Acute Disease
Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML
- Conditions
- Leukemia, Acute Disease, Acute Myeloid Leukemia, Nonlymphocytic Leukemia
- Trial name
- NCT00607997
- Testing
- vosaroxin
- Where
- 20 sites in United States
- Volunteers
- 113 people
- Sponsor
- Sunesis Pharmaceuticals
Acute Myeloid Leukemia, Myelodysplastic Syndrome
A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome
The purpose of this study is to determine the activity of tamibarotene in participants with relapsed/refractory (R/R) AML (administered as a monotherapy or in combination with azacitidine), R/R higher-risk MDS (HR-MDS)…
- Trial name
- NCT02807558
- Testing
- Tamibarotene, Azacitidine, Daratumumab
- Where
- 26 sites in United States, France
- Volunteers
- 155 people
- Sponsor
- Syros Pharmaceuticals
Anemia
Study of Luspatercept for the Treatment of Anemia in Patients With Myelodysplastic Syndrome (MDS) (MK-6143-001)
The purpose of this study is to evaluate the effects of luspatercept (MK-6143, formerly called ACE-536) on anemia in patients with low or intermediate-1 risk myelodysplastic syndrome (MDS).
- Trial name
- NCT01749514
- Testing
- Luspatercept
- Where
- Germany
- Volunteers
- 116 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Myelodysplastic Syndromes
Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study
This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was conducted in 17 countries, started in 2010…
- Trial name
- TELESTO (NCT00940602)
- Testing
- Deferasirox
- Where
- 71 sites in United States, Australia and 14 more
- Volunteers
- 225 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndrome (MDS)
Darbepoetin Alfa MDS Companion Protocol
The primary objective of the study was to provide required access of investigational product (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin alfa MDS 20090160 (NCT01362140) study for…
- Trial name
- NCT02175277
- Testing
- Darbepoetin Alfa
- Where
- 4 sites in Belgium
- Volunteers
- 9 people
- Sponsor
- Amgen
Paroxysmal Nocturnal Hemoglobinuria
Pozelimab and Cemdisiran Combination Therapy in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy
The primary objective of the study is to evaluate the safety and tolerability of pozelimab and cemdisiran combination therapy in participants with PNH who switch from eculizumab therapy The secondary objectives of the study are…
- Trial name
- NCT04888507
- Testing
- Pozelimab, Cemdisiran
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Regeneron Pharmaceuticals
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML
Multicenter PK study of ASTX727 versus IV decitabine. Adult participants who were candidates to receive IV decitabine were randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m^2…
- Conditions
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia
- Trial name
- NCT03306264
- Testing
- ASTX727, Dacogen
- Where
- 84 sites in United States, Austria and 8 more
- Volunteers
- 227 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy
The purpose of this Phase 3 study was to determine whether iptacopan is efficacious and safe for the treatment of Paroxysmal nocturnal hemoglobinuria (PNH) patients who were naïve to complement inhibitor therapy.
- Trial name
- APPOINT-PNH (NCT04820530)
- Testing
- Iptacopan (LNP023)
- Where
- 12 sites in China, France and 6 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndrome, Myelofibrosis
Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza
The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold…
- Conditions
- Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
- Trial name
- NCT01290302
- Testing
- Luitpold Azacitidine, Vidaza®
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- American Regent, Inc.
Paroxysmal Nocturnal Hemoglobinuria
Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Study, Assessing Multiple LNP023 Doses in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria
This was a Phase II randomized, open-label, multicenter, efficacy, safety, pharmacokinetic and pharmacodynamic study assessing four iptacopan doses in adult Paroxysmal nocturnal hemoglobinuria (PNH) patients with active hemolysis…
- Trial name
- NCT03896152
- Testing
- LNP023
- Where
- 5 sites in Malaysia, Singapore and 2 more
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals