Clinical trials: High-risk Myelodysplastic Syndromes
Myelodysplastic Syndrome
Vosaroxin for Intermediate 2 or High-risk MDS After Failure With Hypomethylating Agent-based Therapy
Study WCMC IST/VOS/MDS evaluates the safety and tolerability of escalating doses of vosaroxin in adult patients with pathologically confirmed Myelodysplastic Syndrome, or MDS, (< 20% blasts in bone marrow, peripheral blood, or…
- Trial name
- NCT01980056
- Testing
- Vosaroxin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Weill Medical College of Cornell University
Acute Myelogenous Leukemia
Randomized Study of Haploidentical Hct and Subsequent Donor nk Cell Infusion in High-risk AML and MDS
This is a single center, open label, random comparison phase 2b study. The primary objective of this study is, by random comparison, to assess the anti-leukemia effect of allogeneic, donor-derived natural killer (NK) cells…
- Trial name
- DNKI-4 (NCT02477787)
- Testing
- allogeneic, donor-derived NK cells
- Where
- South Korea
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Asan Medical Center
Myelodysplastic Syndrome (MDS)
Study of Azacitidine to Evaluate Safety and Effectiveness for Chinese Patients With Higher Risk Myelodysplastic Syndrome
The purpose of the study is to determine whether azacitidine is safe and effective in the treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).
- Trial name
- NCT01599325
- Testing
- Azacitidine
- Where
- 11 sites in China
- Volunteers
- 72 people
- Sponsor
- Celgene
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
This first-in-human study will evaluate RVU120 (SEL120), a novel small molecule CDK8/19 inhibitor, in patients with Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (HR-MDS), in terms of selection of the…
- Trial name
- NCT04021368
- Testing
- RVU120(SEL120)
- Where
- 10 sites in United States, Poland
- Volunteers
- 51 people
- Sponsor
- Ryvu Therapeutics SA
Cancer
Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or peripheral stem cell transplantation.
- Trial name
- NCT00008359
- Testing
- caspofungin acetate, liposomal amphotericin B
- Where
- United States
- Sponsor
- Memorial Sloan Kettering Cancer Center
Myelodysplastic Syndromes, Acute Myeloid Leukemia
Combining Active and Passive DNA Hypomethylation
This is a multicentre, randomized, parallel-group, placebo-controlled, double-blind phase 2 study of the efficacy and safety of oral vitamin C supplement in combination with azacitidine in patients with higher-risk MDS, CMML-2 or…
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
- Trial name
- EVI-3 (NCT03999723)
- Testing
- Vitamin C
- Where
- 10 sites in Denmark, Sweden
- Volunteers
- 196 people
- Sponsor
- Kirsten Grønbæk
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
This randomized phase II/III trial studies how well azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone work in treating older patients with newly diagnosed acute myeloid leukemia or high-risk…
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome/Acute Myeloid Leukemia
- Trial name
- NCT03092674
- Testing
- Azacitidine, Cytarabine, Decitabine
- Where
- 506 sites in United States
- Volunteers
- 76 people
- Sponsor
- National Cancer Institute (NCI)
Higher Risk Myelodysplastic Syndromes
Bexmarilimab + Azacitidine Versus Placebo + Azacitidine in Participants With Treatment-naïve Higher-risk Myelodysplastic Syndromes
This Phase IIb study (BEXERA) will evaluate the safety and efficacy of bexmarilimab (FP-1305), an antibody targeting Clever-1, given in combination with azacitidine compared with azacitidine plus placebo in adults with…
- Trial name
- BEXERA (NCT07672769)
- Testing
- bexmarilimab (1mg/kg), azacitidine, bexmarilimab (3mg/kg)
- Where
- 35 sites in United States, Czechia and 5 more
- Volunteers
- 90 people
- Sponsor
- Faron Pharmaceuticals Ltd
Hematologic Malignancy, Acute Myeloid Leukemia
CLL1-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies
Phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CLL1-CD33 cCAR in patients with relapsed and/or refractory, high risk hematologic malignancies.
- Conditions
- Hematologic Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasm
- Trial name
- NCT03795779
- Testing
- CLL1-CD33 cCAR T cells
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia
This phase Ib/II trial tests the best dose of axatilimab and effectiveness of axatilimab with or without azacitidine for the treatment of patients with advanced phase myeloproliferative neoplasms (MPN), myeloproliferative…
- Conditions
- Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myelodysplastic/Myeloproliferative Neoplasm
- Trial name
- NCT06523556
- Testing
- Axatilimab, Azacitidine, Biospecimen Collection
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Uma Borate
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
The purpose of the study is to determine how effective azacitidine, MGCD0103, and the combination of azacitidine and MGCD0103 are in treating AML or MDS in people over 60 years of age.
- Trial name
- NCT00666497
- Testing
- Azacitidine, MGCD0103
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 6 people
- Sponsor
- Mirati Therapeutics Inc.
Leukemia, Myelodysplastic Syndrome
Pharmacokinetics of Anidulafungin (Ecalta ®) Intravenous Given to Patients at High Risk for Developing Invasive Fungal Disease
The purpose of this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative…
- Conditions
- Leukemia, Myelodysplastic Syndrome, Leukemia, Myeloid, Acute
- Trial name
- ANIDULAPK (NCT01249820)
- Testing
- anidulafungin 200 mg q48h, anidulafungin 300 mg q72h
- Where
- Netherlands
- Volunteers
- 26 people
- Sponsor
- Radboud University Medical Center
Graft Versus Host Disease, Leukemia
Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of…
- Conditions
- Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Trial name
- NCT00014469
- Testing
- busulfan, melphalan, methotrexate
- Where
- United States
- Sponsor
- Memorial Sloan Kettering Cancer Center
High Risk MDS
Phase II Study to Evaluate Overall Response in Patients With Higher Risk Myelodysplastic Syndromes (MDS) Treated With Azacitidine With or Without Deferasirox.
The primary objective of the study is to compare the overall response rate (inclusive of complete response, partial response and hematologic improvement) per IWG 2006 criteria in patients with higher risk MDS treated with…
- Trial name
- NCT02159040
- Testing
- Azacitidine, Azacitidine plus Deferasirox
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Novartis Pharmaceuticals
High-risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (CMML)
A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias
Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed/refractory AML, HR-MDS, CMML, and CML. Participants aged ≥ 12 years are planned to be enrolled.
- Conditions
- High-risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (CMML), AML - Acute Myeloid Leukemia, Chronic Myeloid Leukemia
- Trial name
- CROSSCHECK-001 (NCT06994676)
- Testing
- CBX-250
- Where
- 11 sites in United States
- Volunteers
- 72 people
- Sponsor
- Crossbow Therapeutics, Inc.
Myelodysplastic Syndromes or Acute Myeloid Leukemia With Multilineage Dysplasia
Characterization of the Mechanisms of Resistance to Azacitidine
Myelodysplastic syndromes (MDS) are frequent diseases in elderly patients (median age: 71 years). IPSS classification defines low risk (Low and Intermediate 1), and high risk (Intermediate 2 and High) MDS.
- Trial name
- NCT01210274
- Where
- 4 sites in France, Monaco
- Volunteers
- 250 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Myelodysplastic Syndromes
A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).
This Phase II was a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R…
- Trial name
- STIMULUS-MDS1 (NCT03946670)
- Testing
- MBG453, Hypomethylating agents
- Where
- 48 sites in United States, Austria and 15 more
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
Relapsed/Refractory Multiple Myeloma (RRMM), Metastatic Colorectal Cancer (mCRC)
Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications
This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1…
- Conditions
- Relapsed/Refractory Multiple Myeloma (RRMM), Metastatic Colorectal Cancer (mCRC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Higher-Risk Myelodysplastic Syndrome (HR-MDS)
- Trial name
- NCT02649790
- Testing
- KPT-8602, ASTX727, Dexamethasone
- Where
- 46 sites in United States, Canada and 3 more
- Volunteers
- 277 people
- Sponsor
- Karyopharm Therapeutics Inc
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Intraosseous Infusion of Unrelated Cord Blood Grafts
In this trial the investigators seek to determine if injecting cord blood cells directly into the bone marrow (intraosseous injection), rather than infusing them intravenously, can improve engraftment.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT00967525
- Testing
- cord blood infusion
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Emory University
AML/MDS
Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients
The aim of this study is to investigate how safe and effective the addition of the new medicine midostaurin to decitabine is for the treatment of unfit acute myeloid leukemia (AML) and high-risk myelodysplasia (MDS) patients.
- Trial name
- HO155 (NCT04097470)
- Testing
- Decitabine, Midostaurin
- Where
- 37 sites in Belgium, Germany and 2 more
- Volunteers
- 140 people
- Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland