Myelodysplastic Syndromes (MDS) Clinical Trial
Official title:
The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study
NCT number | NCT02390414 |
Other study ID # | 11-056 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2011 |
Est. completion date | September 2020 |
Verified date | March 2023 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this observational study is to compare overall survival in older adults with myelodysplastic syndromes (MDS) who receive reduced intensity conditioning hematopoietic stem cell transplant (RIC HSCT) versus those who do not receive HSCT.
Status | Completed |
Enrollment | 290 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 75 Years |
Eligibility | Inclusion Criteria: - Histologically-confirmed diagnosis of: - Primary or secondary MDS using the World Health Organization (WHO) 2008 classification: - Refractory cytopenia with unilineage dysplasia - Refractory Anemia (RA) - Refractory Neutropenia (RN) - Refractory Thrombocytopenia (RT) - Refractory Anemia with Ring Sideroblasts (RARS) - Refractory Cytopenia with Multilineage Dysplasia (RCMD) - Refractory Anemia with Excess Blasts-1 (RAEB-1) - Refractory Anemia with Excess Blasts-2 (RAEB-2) - MDS with isolated del (5q) - MDS-Unclassified (MDS-U) - Another of the following related disorders: - Chronic Myelomonocytic leukemia (CMML) - Myelodysplastic/myeloproliferative neoplasm, unclassifiable (MDS/MPD-U) - Age 60 to 75 years - Any of the following (high-risk characteristics): - Intermediate-2 or High-Risk on International Prognostic Scoring System (IPSS) - Secondary MDS (any karyotype) - Documented non-IPSS intermediate- or poor-prognosis karyotype including: - +8 - t(11q23) - Rea 3q - +19 - 3 or greater abnormalities - del(7q) - -5 - t(5q) - Documented significant cytopenia for at least four months prior to enrollment, defined by the following criteria: - Red Blood Cell (RBC) Transfusion Dependence: four or more units of RBC transfusions within an eight-week period for symptomatic anemia with hemoglobin of = 9.0 g/dL; OR - Severe Anemia: average of two or more hemoglobin values = 8 g/dL within an eight-week period not influenced by RBC transfusions (i.e., must be seven days post transfusion); OR - Severe Thrombocytopenia: average of two or more platelet counts = 50 × 109/L within an eight-week period not influenced by platelet transfusions (i.e., must be at least three days post- transfusion) or a clinically significant hemorrhage requiring platelet transfusions within the prior four months; OR - Severe Neutropenia: average of two or more absolute neutrophil counts (ANC) = 500 within an eight-week period, or a clinically significant infection requiring IV antibiotics in the setting of ANC = 1000 within the prior four months. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. - Adequate organ function to permit RIC HSCT as indicated by the following: - Serum bilirubin = 2.5 mg/dL (except when Gilbert's syndrome or MDS-related hemolysis suspected). - Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) = 2.5 times the upper limit of normal (ULN). - Serum creatinine = 2.0 mg/dL. - Seemingly sufficient baseline cardiac function to undergo HSCT (no echocardiogram required). - Seemingly sufficient baseline pulmonary function to undergo HSCT (no pulmonary function tests required). - Seemingly sufficient neuro-psychiatric function to undergo HSCT (no specific neuro-psychiatric evaluation required). - Willingness to undergo human leukocyte antigen (HLA)-typing and consider subsequent HSCT. - Willingness and ability to give informed consent. Exclusion Criteria: - Known baseline conversion to AML (eg, = 20% peripheral or marrow blasts). - Knowledge of potential donor status at study entry. Of note, knowledge of HLA status WITHOUT a related or unrelated search is allowed. - History of prior malignancy within the past year, except for adequately-treated carcinoma in situ of uterine cervix, basal cell or squamous cell skin cancer. - Any severe concurrent disease, infection, or comorbidity that, in the judgment of the principal investigator, would make the patient inappropriate for HSCT at the time of study entry. - Psychiatric disorders including dementia that would preclude obtaining informed consent or the ability to participate in an ongoing research study. |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | To prospectively compare the overall survival of patients in the HSCT group to that of patients in the non-HSCT group. | 3 Years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02550535 -
A Phase I/II Study of Gene-modified WT1 TCR Therapy in MDS & AML Patients
|
Phase 1/Phase 2 | |
Completed |
NCT00186342 -
Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies
|
N/A | |
Completed |
NCT00528983 -
Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myelogenous Leukemia
|
Phase 1 | |
Completed |
NCT01355913 -
Screening and Genetic Monitoring of Patients With Myelodysplastic Syndromes (MDS) Under Different Treatment Modalities by Cytogenetic Analyses of Circulating CD34+Cells
|
||
Withdrawn |
NCT04985656 -
A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes
|
Phase 2 | |
Completed |
NCT01736683 -
Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)
|
Phase 2 | |
Completed |
NCT02333058 -
Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies
|
Phase 2 | |
Completed |
NCT01135849 -
B-Receptor Signaling in Cardiomyopathy
|
N/A | |
Withdrawn |
NCT04395092 -
Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)
|
Phase 2 | |
Completed |
NCT01885897 -
IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT
|
Phase 1/Phase 2 | |
Recruiting |
NCT05092451 -
Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances
|
Phase 1/Phase 2 | |
Recruiting |
NCT05884333 -
Cord Blood Transplant in Adults With Blood Cancers
|
Phase 2 | |
Completed |
NCT01326377 -
ON 01910.Na for Intermediate1-2, or High Risk Trisomy 8 Myelodysplastic Syndrome (MDS)
|
Phase 2 | |
Completed |
NCT02966782 -
A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS)
|
Phase 1 | |
Recruiting |
NCT02779569 -
A Clinical Trial Evaluating the Efficacy of Ultra Low Dose of Decitabine in Myelodysplastic Syndromes (MDS)
|
N/A | |
Recruiting |
NCT02099669 -
Red Blood Cell Transfusion Thresholds and QOL in MDS
|
N/A | |
Completed |
NCT01392989 -
Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders
|
Phase 2 | |
Not yet recruiting |
NCT06398457 -
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
|
Early Phase 1 | |
Recruiting |
NCT02775383 -
The National Myelodysplastic Syndromes (MDS) Study
|
||
Recruiting |
NCT04275518 -
A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
|
Phase 1 |