Clinical trials: High-risk Myelodysplastic Syndromes
Myelodysplastic Syndromes
Vorinostat and Low Dose Cytarabine for High Risk Myelodysplasia
The purpose of this study is to determine the maximum tolerated duration and schedule of oral VORINOSTAT in addition to low dose cytarabine in the treatment of Intermediate-2 and High risk myelodysplastic syndromes.
- Trial name
- GFMVOR2007 (NCT00776503)
- Testing
- VORINOSTAT
- Where
- 14 sites in France
- Volunteers
- 52 people
- Sponsor
- Groupe Francophone des Myelodysplasies
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
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
Cancer
Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus. PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have…
- Trial name
- NCT00769613
- Testing
- cytomegalovirus IE-1-specific cytotoxic T lymphocytes, cytomegalovirus pp65-specific cytotoxic T lymphocytes, therapeutic allogeneic lymphocytes
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Milton S. Hershey Medical Center
Myelodysplastic Syndrome (MDS)
STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
The main objective of this study was to assess the safety profile of MBG453 (sabatolimab) in combination with FDA approved hypomethylating agents (HMAs) of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral…
- Trial name
- NCT04878432
- Testing
- MBG453, Azacitidine, Decitabine
- Where
- 15 sites in United States
- Volunteers
- 39 people
- Sponsor
- Novartis Pharmaceuticals
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
Acute Biphenotypic Leukemia, de Novo Myelodysplastic Syndrome
Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
This phase I/II trial studies the side effects and best dose of mitoxantrone hydrochloride when given together with filgrastim, cladribine, and cytarabine and to see how well they work in treating patients with acute myeloid…
- Conditions
- Acute Biphenotypic Leukemia, de Novo Myelodysplastic Syndrome, Previously Treated Myelodysplastic Syndrome, Recurrent Adult Acute Myeloid Leukemia
- Trial name
- NCT02044796
- Testing
- Cladribine, Cytarabine, Filgrastim
- Where
- United States
- Volunteers
- 199 people
- Sponsor
- Fred Hutchinson Cancer Center
Acute Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant
This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or…
- Conditions
- Acute Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Diffuse Large B-Cell Lymphoma
- Trial name
- NCT03128359
- Testing
- Busulfan, Cyclophosphamide, Fludarabine Phosphate
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- City of Hope 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
Myelodysplastic Syndromes
A Study to Investigate the Efficacy and Safety of Roxadustat (FG-4592) for Treating Anemia in Participants With Myelodysplastic Syndromes (MDS)
The study is designed to determine the efficacy and safety of roxadustat for the treatment of anemia due to very low, low, or intermediate risk MDS in participants with high transfusion burden (HTB).
- Trial name
- NCT07722988
- Testing
- Roxadustat
- Volunteers
- 201 people
- Sponsor
- Kyntra Bio
Cancer
Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy
RATIONALE: Vaccines may help the body build an effective immune response to kill cytomegalovirus infections. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who have…
- Trial name
- NCT00509691
- Testing
- cytomegalovirus pp65-specific cytotoxic T lymphocytes, polymerase chain reaction, diagnostic laboratory biomarker analysis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Louisville
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q)
Sirolimus and Azacitidine in Treating Patients With High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia That is Recurrent or Not Eligible for Intensive Chemotherapy
This phase II trial studies how well sirolimus and azacitidine works in treating patients with high-risk myelodysplastic syndrome or recurrent acute myeloid leukemia.
- 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
- NCT01869114
- Testing
- Sirolimus, Azacitidine
- Where
- 5 sites in United States
- Volunteers
- 57 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Myelogenous Leukemia, Acute, Myelodysplastic Syndromes
MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease
In this study, MGCD0103, a new anticancer drug under investigation, is given three times per week to elderly patients with previously untreated acute myelogenous leukemia/high risk myelodysplastic syndrome or adults with…
- Trial name
- NCT00374296
- Testing
- MGCD0103
- Where
- 13 sites in United States, Canada
- Volunteers
- 35 people
- Sponsor
- Mirati Therapeutics Inc.
Myelodysplastic Syndromes
Venetoclax-containing Therapy Combined With Microtransplant for Intermediate-risk and Higher MDS
This study aims to evaluate the safety and efficacy of a Venetoclax and hypomethylating agent-based regimen combined with infusion of HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cells (GPBMC) in patients…
- Trial name
- NCT07238686
- Testing
- Venetoclax, Azacitidine (AZA) or Decitabine (DAC), GPBMC infusion
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Beijing 302 Hospital
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
Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
A Phase II Study Of The Farnesyltransferase Inhibitor ZANESTRA (R115777, NSC #702818, IND #58,359) In Complete Remission Following Induction And/Or Consolidation Chemotherapy In Adults With Poor-Risk Acute Myelogenous Leukemia (AML) And High-Risk Myelodysplasia (MDS)
Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of tipifarnib in treating patients who have acute myeloid leukemia or myelodysplastic…
- Conditions
- Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Trial name
- NCT00045396
- Testing
- tipifarnib
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- National Cancer Institute (NCI)
Myelodysplastic Syndromes
Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q
Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is currently tested in non del 5q MDS patients.
- Trial name
- GFM-AZA-REV-09 (NCT01088373)
- Testing
- Azacitidine combined to Lenalidomide
- Where
- 34 sites in France
- Volunteers
- 50 people
- Sponsor
- Groupe Francophone des Myelodysplasies
Myelodysplastic Syndromes
Treatment of High Risk Myelodysplastic Syndromes (MDS) Not Candidates for Allogeneic Transplantation of Hematopoietic Progenitors (ALO-HSCT)
An observational, non-interventional, prospective and multicenter study of Azacitidine in newly diagnosed High Risk Myelodysplastic Syndromes.
- Trial name
- NCT04602273
- Testing
- Azacitidine Injection [Vidaza]
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Acute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia
Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia
This phase II clinical trial is studying how well giving busulfan, fludarabine phosphate, and anti-thymocyte globulin followed by donor stem cell transplant and azacitidine works in treating patients with high-risk…
- Conditions
- Acute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic Leukemia
- Trial name
- NCT01168219
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Anti-Thymocyte Globulin, Azacitidine
- Where
- 17 sites in United States
- Volunteers
- 68 people
- Sponsor
- National Cancer Institute (NCI)
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia
This phase I/II trial studies the side effects and best dose of 211^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic…
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
- Trial name
- NCT03128034
- Testing
- Cyclosporine, Fludarabine Phosphate, Mycophenolate Mofetil
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Fred Hutchinson Cancer Center