Clinical trials: Higher-risk Myelodysplastic Syndrome
Myelodysplastic Syndrome
Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia
This is a phase II study of lenalidomide in patients with myelodysplastic syndrome (MDS) and with acute myeloid leukemia (AML) with trilineage dysplasia. Patients will receive two cycles of lenalidomide.
- Trial name
- NCT00867308
- Testing
- Lenalidomide 50 mg, Lenalidomide 15 mg
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 Syndromes
LBH589 Plus Decitabine for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)
This study is designed to evaluate the combination of LBH589 and decitabine in patients age ≥ 60 years with high risk Myelodysplastic Syndrome (IPSS Int-2 or High) or Acute Myeloid Leukemia.
- Trial name
- NCT00691938
- Testing
- LBH589, Decitabine
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Washington University School of Medicine
Leukemia
Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation
The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can help to control the disease in patients with Acute Myeloid Leukemia (AML) and high risk Myelodisplastic Syndrome (MDS) with FLT3-ITD…
- Trial name
- NCT02196857
- Testing
- Azacytidine, Sorafenib
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- M.D. Anderson Cancer Center
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Study of ARGX-110 in Combination With Azacytidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)
The purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of…
- Trial name
- NCT03030612
- Testing
- ARGX-110, AZA
- Where
- 7 sites in France, Switzerland
- Volunteers
- 38 people
- Sponsor
- OncoVerity, Inc.
AML
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the…
- Trial name
- VOYAGE (NCT02152956)
- Testing
- Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
- Where
- 43 sites in United States, France and 6 more
- Volunteers
- 244 people
- Sponsor
- MacroGenics
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
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q)
Bendamustine and Idarubicin in Treating Older Patients With Previously Untreated AML or MDS
This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride when given together with idarubicin in treating older patients with previously untreated acute myeloid leukemia (AML) or…
- Conditions
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Trial name
- NCT01141725
- Testing
- bendamustine hydrochloride, idarubicin
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Fred Hutchinson Cancer Center
Myelodysplastic Syndrome (MDS), Infection
Myelodysplasic Syndromes and Risk Factors for Infection
Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone marrow failure and by a disorder of the medullary production which is a pre-leukemic state which can evolve into acute myeloid leukemia.
- Conditions
- Myelodysplastic Syndrome (MDS), Infection, Risk Factors, IPSS High Risk
- Trial name
- MYRIFIC (NCT02905552)
- Testing
- No intervention
- Where
- France
- Volunteers
- 320 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Myelodysplastic Syndromes, Acute Myeloid Leukemia
Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy
The purpose of this study is to evaluate the efficacy, in terms of hematologic improvement, and safety of imetelstat in participants with high-risk (HR) myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that is…
- Trial name
- IMpress (NCT05583552)
- Testing
- Imetelstat sodium
- Where
- 11 sites in Australia, France and 1 more
- Volunteers
- 46 people
- Sponsor
- GCP-Service International West GmbH
Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
This phase II trial studies the side effects and how well fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride work in treating patients with newly diagnosed acute myeloid…
- Conditions
- Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, de Novo Myelodysplastic Syndrome
- Trial name
- NCT00801489
- Testing
- Cytarabine, Decitabine, Filgrastim-sndz
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- M.D. Anderson Cancer Center
Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL
Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies.
- Conditions
- Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia, Relapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm
- Trial name
- ADAPT-HEM (NCT07523555)
- Testing
- Autologous CD19/CD22 dual-target CAR-T module, Autologous CD19/CD20 dual-target CAR-T module, Autologous BCMA/CD19 dual-target CAR-T module
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Beijing Biotech
Myelodysplastic Syndrome, Acute Myeloblastic Leukemia
SMD_FLAG-IDA_98: FLAG-IDA in Induction Treatment of High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia
Association group of therapeutic specialities authorized in a remission induction treatment(FLAG-IDA: fludarabine, cytarabine, G-CSF (lenograstim) and idarubicin) and an intensive postremission treatment with authorized…
- Trial name
- FLAG-IDA (NCT00487448)
- Testing
- Fludarabine, Cytarabine, G-CSF
- Where
- 15 sites in Spain
- Volunteers
- 200 people
- Sponsor
- PETHEMA Foundation
Myelodysplastic Syndromes
Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients
This study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is non-inferior to HSCT following bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS).
- Trial name
- ImmBridge (NCT06918834)
- Testing
- Immediate HSCT Group, Bridging Therapy Group
- Where
- 5 sites in China
- Volunteers
- 236 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological…
- Conditions
- Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory, Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasia
- Trial name
- NCT05086315
- Testing
- SAR443579
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 101 people
- Sponsor
- Sanofi
Acute Leukemia, Chronic Leukemia
Nonmyeloablative Haploidentical Transplant Followed by MLN9708
In an attempt to reduce relapse risk and improve outcomes following haploidentical transplantation for patients with high risk hematologic malignancies, the investigators will implement several strategies to augment the well…
- Conditions
- Acute Leukemia, Chronic Leukemia, Myelodysplastic Syndrome, Lymphomas
- Trial name
- NCT02169791
- Testing
- MLN9708
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Northside Hospital, Inc.
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q)
Clofarabine and Cytarabine in Treating Older Patients With AML or High-Risk MDS
This phase I/II trial studied the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating older patients with acute myeloid leukemia (AML) or high-risk…
- Conditions
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Trial name
- NCT00839982
- Testing
- clofarabine, cytarabine
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Fred Hutchinson Cancer Center
Hematopoietic and Lymphoid Cell Neoplasm, High Risk Acute Myeloid Leukemia
Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant
This phase II trial studies the side effect of busulfan, fludarabine phosphate, and post-transplant cyclophosphamide in treating patients with blood cancer undergoing donor stem cell transplant.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, High Risk Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, Lymphoproliferative Disorder
- Trial name
- NCT02861417
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Cyclophosphamide
- Where
- United States
- Volunteers
- 204 people
- Sponsor
- M.D. Anderson Cancer Center
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Decitabine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
This phase I trial is studying the side effects and best dose of decitabine in treating patients with myelodysplastic syndromes or acute myeloid leukemia.
- Conditions
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Trial name
- NCT00049582
- Testing
- decitabine, laboratory biomarker analysis, pharmacological study
- Where
- Canada
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
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