Clinical trials: AML/MDS
Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL)
Cord Blood Transplant in Adults With Blood Cancers
Cord blood transplants (CBT) are a standard treatment for adults with blood cancers. MSK has developed a standard ("optimized") practice for cord blood transplant (CBT).
- Conditions
- Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CML), Myelodysplastic Syndromes (MDS)
- Trial name
- NCT05884333
- Testing
- Conditioning Chemotherapy, Cord blood graft
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
AML, Adult, MDS
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML/HR-MDS and in Combination With Azacitidine in Previously Untreated HR-MDS
This is a Phase 1b open-label, multicenter, dose-escalation and randomized combination cohort study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of…
- Trial name
- NCT06533761
- Testing
- Eganelisib, Eganelisib in combination with cytarabine, Eganelisib in combination with azacitidine
- Where
- 12 sites in United States, Spain
- Volunteers
- 105 people
- Sponsor
- Stelexis BioSciences
AML (Acute Myelogenous Leukemia), MDS (Myelodysplastic Syndrome)
Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD)
AlloHeme is a blood-based monitoring test developed by the CareDx laboratory that utilizes NGS technology coupled with a proprietary algorithm to predict the likelihood of a relapse in post-allo-HCT AML/MDS patients.
- Conditions
- AML (Acute Myelogenous Leukemia), MDS (Myelodysplastic Syndrome), CMML
- Trial name
- FORWARD (NCT07607327)
- Testing
- AlloHeme
- Where
- 3 sites in United States
- Volunteers
- 400 people
- Sponsor
- CareDx
Ropeginterferon, Alfa-2b
A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in MDS/AML With TP53 Mutations
To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS/AML with TP53 mutations.
- Conditions
- Ropeginterferon, Alfa-2b, Azacitidine, MDS/AML
- Trial name
- NCT07646821
- Testing
- ropeginterferon alfa- 2b, Azacitidine (AZA)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- M.D. Anderson Cancer Center
AML/MDS, Acute Myeloid Leukemia
Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML
This is a Phase 1 study investigating the safety and efficacy of Danvatirsen as a monotherapy followed by combination with Venetoclax in patients with relapsed/refractory myelodysplastic syndromes (MDS) or acute myeloid leukemia…
- Conditions
- AML/MDS, Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Trial name
- NCT05986240
- Testing
- Danvatirsen, Danvatirsen + Venetoclax
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
R/R AML, R/R HR-MDS
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety.
- Conditions
- R/R AML, R/R HR-MDS, Acute Myeloid Leukemia, Higher-Risk Myelodysplastic Syndrome
- Trial name
- NCT07384715
- Testing
- GEN3018
- Where
- 6 sites in Denmark, Spain
- Volunteers
- 78 people
- Sponsor
- Genmab
AML, MDS
A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA)
This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating…
- Trial name
- NCT05473910
- Testing
- SOC + TSC-101, Control, SOC + TSC-100
- Where
- 21 sites in United States
- Volunteers
- 310 people
- Sponsor
- TScan Therapeutics, Inc.
Hematologic Malignancy, Bone Marrow Transplant Rejection
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor…
- Conditions
- Hematologic Malignancy, Bone Marrow Transplant Rejection, Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS)
- Trial name
- NCT06398457
- Testing
- Darzalex Faspro (Daratumumab and hyaluronidase-fihj), JH-DSA Semi-Quant Screen and Response Score
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
AML, MDS
A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
This is a multicenter, genetically-randomized, controlled, Phase 3 study evaluating the efficacy and safety of T-cell receptor-engineered donor T cells targeting HA-2 (TSC-101) administered following reduced-intensity…
- Trial name
- ALLOHA-2 (NCT07702578)
- Testing
- TSC-101, Control
- Where
- 26 sites in United States
- Volunteers
- 310 people
- Sponsor
- TScan Therapeutics, Inc.
Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies
- Conditions
- Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma
- Trial name
- NCT05877599
- Testing
- NT-175
- Where
- 20 sites in United States
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
MYELODYSPLASTIC SYNDROME; MDS, ACUTE MYELOID LEUKEMIA; AML
JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation
This is a Phase 1a/b study to evaluate the safety and tolerability of an antibody conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine, in subjects with Myelodysplastic Syndrome (MDS) or…
- Trial name
- NCT04429191
- Testing
- Humanized anti-CD117 Monoclonal Antibody (JSP191)
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Jasper Therapeutics, Inc.
Myelodysplastic Syndrome(MDS), Acute Myelogenous Leukemia (AML)
A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem/progenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of…
- Trial name
- NCT06548230
- Testing
- Nadunolimab, Azacitidine, Venetoclax
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- M.D. Anderson Cancer Center
Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML)
TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies
Patients less than or equal to 21 years old with high-risk hematologic malignancies who would likely benefit from allogeneic hematopoietic cell transplantation (HCT).
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), NK-Cell Leukemia
- Trial name
- NCT03849651
- Testing
- Cyclophosphamide, Fludarabine, Thiotepa
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- St. Jude Children's Research Hospital
MDS, AML
Allogeneic Stem Cell Transplant With Clofarabine, Busulfan and Antithymocyte Globulin (ATG) for Adult Patients With High-risk Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS) or Acute Lymphoblastic Leukemia (ALL)
Clofarabine is known to have a stronger anti-tumor effect than Fludarabine and has shown its efficacy in treating aggressive acute leukemias.
- Conditions
- MDS, AML, ALL, BAL
- Trial name
- Cloric (NCT00863148)
- Testing
- Clofarabine in combination with IV busulfan and ATG
- Where
- 6 sites in France
- Volunteers
- 30 people
- Sponsor
- Nantes University Hospital
Leukemia, Myeloid, Acute(AML), Precursor Cell Lymphoblastic Leukemia-Lymphoma
CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial
Adult patients with refractory or relapsed CD123+ hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or blastic plasmocytoid dentritic cell neoplasm will be…
- Conditions
- Leukemia, Myeloid, Acute(AML), Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes (MDS), Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- Trial name
- UHKT-CAR123-01 (NCT06765876)
- Testing
- Autologous CAR123 T lymphocytes
- Where
- Czechia
- Volunteers
- 18 people
- Sponsor
- Institute of Hematology and Blood Transfusion, Czech Republic
MDS, AML
Comparison of Therapies Before Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML
To compare the event-free survival at 2 years of CPX-351 vs. conventional care regimens before allogeneic blood cell transplantation as first line treatment in patients with higher risk MDS and oligoblastic AML.
- Trial name
- PALOMA (NCT04061239)
- Testing
- CPX-351, Daunorubicin, Cytarabine
- Where
- 27 sites in Austria, Germany
- Volunteers
- 150 people
- Sponsor
- GWT-TUD GmbH
AML, Adult Recurrent, ALL, Recurrent, Adult
BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS
The goal of this clinical trial is to test BSB-1001 which is a new type of cellular therapy to treat blood cancers (AML, ALL and MDS).
- Conditions
- AML, Adult Recurrent, ALL, Recurrent, Adult, MDS
- Trial name
- NCT06704152
- Testing
- SOC + BSB-1001 Dose Escalation Cohort, SOC+BSB-1001 Expansion Dose
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- BlueSphere Bio, Inc
AML - Acute Myeloid Leukemia, MDS (Myelodysplastic Syndrome)
Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation
The aim of this study is to compare the effectiveness and tolerability of two conditioning chemotherapies prior to allogeneic stem cell transplantation.
- Trial name
- RELEVANT (NCT07025824)
- Testing
- Treosulfan (Treo), Melphalan (Mel), Fludarabine (Flud)
- Where
- 17 sites in Germany
- Volunteers
- 220 people
- Sponsor
- Technische Universität Dresden
Graft Vs Host Disease, Peripheral Blood Stem Cell Transplantation
GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG
Post-transplantation cyclophosphamide (PTCY) has become increasingly popular in the haploidentical HCT setting because it overcomes the HLA-mismatch barrier and levels GVHD risk.
- Conditions
- Graft Vs Host Disease, Peripheral Blood Stem Cell Transplantation, AML, MDS
- Trial name
- GRAPPA (NCT05153226)
- Testing
- Cyclophosphamide, ATG
- Where
- 23 sites in Germany
- Volunteers
- 640 people
- Sponsor
- DKMS gemeinnützige GmbH
AML, MDS
Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation
maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days
- Trial name
- PIVOT (NCT06717958)
- Testing
- Ivosidenib 250 MG (milligram)
- Where
- 17 sites in Germany
- Volunteers
- 76 people
- Sponsor
- Technische Universität Dresden