Clinical trials: Higher-risk Myelodysplastic Syndrome
Acute Myelogenous Leukemia, Myelodysplastic Syndromes
A Phase 2a, Open-Label, Two Stage Study of Nerofe or Nerofe With Doxorubicin in Subjects With AML or MDS
This is a Phase 2a, Open-label, one arm study in which the eligible patients will be treated with IV Nerofe, three times a week in 28 days cycles (up to 12 cycles).
- Trial name
- NCT03059615
- Testing
- Nerofe, Doxorubicin
- Where
- 2 sites in Israel
- Sponsor
- Immune System Key Ltd
Advanced Solid Tumors, Acute Myeloid Leukaemia (AML)
RVU120 Rollover Study
This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the time on treatment when…
- Conditions
- Advanced Solid Tumors, Acute Myeloid Leukaemia (AML), High-risk Myelodysplastic Syndrome
- Trial name
- ROVER-01 (NCT06987058)
- Testing
- RVU120, Ruxolitinib
- Where
- 7 sites in France, Poland
- Volunteers
- 14 people
- Sponsor
- Ryvu Therapeutics SA
Myelodysplastic Syndrome (MDS)
A Study of BLEX 404 Oral Liquid in Patients With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-Risk Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML)
This is a clinical trial to determine the safety, recommended dose level (RDL), and infection control of BLEX 404 Oral Liquid in combination with azacitidine in patients with International Prognostic Scoring System (IPSS)…
- Trial name
- NCT02944955
- Testing
- BLEX 404 Oral Liquid
- Volunteers
- 52 people
- Sponsor
- BioLite, Inc.
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
Myelodysplastic Syndrome, Myelodysplastic Syndromes
Safety, Clinical Activity, Pharmacokinetics (PK) and Pharmacodynamics Study of GSK2879552, Alone or With Azacitidine, in Subjects With High Risk Myelodysplastic Syndromes (MDS)
This is a Phase I/II, open-label, 2 arm study to evaluate the safety and clinical activity of GSK2879552 alone, or in combination with azacitidine in subjects with MDS. The study consisted of 2 parts.
- Trial name
- NCT02929498
- Testing
- GSK2879552, Azacitidine
- Where
- 6 sites in United States, Spain
- Volunteers
- 7 people
- Sponsor
- GlaxoSmithKline
Leukemia, Myeloid, Acute
A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment
The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment naïve acute myeloid leukemia (AML) who are…
- Trial name
- NCT04241549
- Testing
- Cusatuzumab, Azacitidine
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- OncoVerity, Inc.
Myelodysplastic Syndromes, Myelogenous Leukemia, Acute
A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome
This study will assess the safety and efficacy of vismodegib in patients with relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS).
- Trial name
- NCT01880437
- Testing
- cytarabine, vismodegib
- Where
- 14 sites in United States, Canada and 1 more
- Volunteers
- 38 people
- Sponsor
- Hoffmann-La Roche
Acute Myeloid Leukemia, Myelodysplastic Syndromes
PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS
This is a first-in-human dose escalation/dose expansion study to evaluate the safety and identify the best dose of modified immune cells, PRGN-3006 (autologous chimeric antigen receptor (CAR) T cells), in adult patients with…
- Trial name
- NCT03927261
- Testing
- PRGN-3006 T Cells
- Where
- 2 sites in United States
- Volunteers
- 88 people
- Sponsor
- Precigen, Inc
Leukemia, Leukemia, Myeloid
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome…
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Preleukemia
- Trial name
- NCT06501196
- Testing
- BH-30236, Venetoclax
- Where
- 13 sites in United States
- Volunteers
- 170 people
- Sponsor
- BlossomHill Therapeutics
Myelodysplastic Syndrome (MDS)
A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants
The purpose of the study was to find out if the new drug sabatolimab when given in combination with azacitidine and venetoclax, was safe and had beneficial effects in participants with high or very high risk myelodysplastic…
- Trial name
- STIMULUS-MDS3 (NCT04812548)
- Testing
- sabatolimab, azacitidine, venetoclax
- Where
- 10 sites in Belgium, France and 5 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and…
- Trial name
- NCT02641002
- Testing
- CC-90002
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Celgene
Myelodysplastic Syndrome (MDS)
A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes
An open label, Phase 1, study of AMV564 as monotherapy to assess the safety and efficacy in patients with Myelodysplastic Syndromes
- Trial name
- NCT03516591
- Testing
- AMV564 14-Day CIV
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Amphivena Therapeutics, Inc.
High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia
GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies
This is a multi-center Phase I/II clinical trial of GTB-3550 (CD16/IL-15/CD33) tri-specific killer cell engager (TriKE®) for the treatment of CD33-expressing high risk myelodysplastic syndromes, refractory/relapsed acute myeloid…
- Conditions
- High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia, Systemic Mastocytosis, Mast Cell Leukemia
- Trial name
- NCT03214666
- Testing
- GTB-3550 TriKE® Phase I, GTB-3550 TriKE® Phase II
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- GT Biopharma, Inc.
Myelodysplastic Syndromes
Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)
The primary purpose of this study is to determine the effectiveness and safety of azacitidine in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).
- Trial name
- NCT01201811
- Testing
- Azacitidine
- Where
- 11 sites in Taiwan
- Volunteers
- 44 people
- Sponsor
- Celgene
Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN)
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm…
- Conditions
- Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL), Aggressive Systemic Mastocytosis (ASM)
- Trial name
- NCT04996875
- Testing
- bezuclastinib
- Where
- 42 sites in United States, Australia and 12 more
- Volunteers
- 140 people
- Sponsor
- Cogent Biosciences, Inc.
Acute Myeloid Leukemia
A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies
This is an open-label, multi-center, Phase 1 study of PF-04449913 in Japanese patients. PF-04449913 will be administered orally as a single agent in patients with select advanced hematologic malignancies, or in combination with…
- Trial name
- NCT02038777
- Testing
- PF-04449913, Low dose ARA-C (LDAC), Daunorubicin
- Where
- 9 sites in Japan
- Volunteers
- 48 people
- Sponsor
- Pfizer
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or…
- Trial name
- NCT04477291
- Testing
- CG-806
- Where
- 10 sites in United States
- Volunteers
- 45 people
- Sponsor
- Aptose Biosciences Inc.
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
Myelodysplastic Syndrome
Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS
This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk…
- Trial name
- NCT02706899
- Testing
- vadastuximab talirine, Azacitidine
- Where
- 34 sites in United States
- Volunteers
- 19 people
- Sponsor
- Seagen Inc.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)
The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for…
- Trial name
- NCT04264806
- Testing
- Azacitidine, Cusatuzumab
- Where
- 73 sites in Australia, Brazil and 9 more
- Sponsor
- Janssen Research & Development, LLC