Myelodysplastic Syndromes Clinical Trial
Official title:
Epigenetic Priming With 5-Azacytidine Prior to in Vivo T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With High Risk Myeloid Malignancies in Morphologic Remission
Verified date | August 2021 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether 5-Azacytidine priming before the conditioning regimen for subjects receiving a hematopoietic stem cell transplant is an effective treatment for high risk myeloid malignancies in complete remission (CR).
Status | Completed |
Enrollment | 40 |
Est. completion date | June 17, 2021 |
Est. primary completion date | June 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must have histologically or cytologically confirmed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) as specified below: 1. Acute myeloid leukemia with poor risk cytogenetics in complete morphologic remission. These include: del (5q)/-5, del (7q)/-7, abn 3q, 9q, 11q, 20q, 21q, 17p, t(6;9), t(9;22) or complex karyotypes (= 3 unrelated abnormalities); or 2. Acute myeloid leukemia with either Flt-3, TET-2, p53, DNMT3A, or ASXL1 mutation, mutations of genes involved in the chromatin/spliceosome category (EZH2, SRSF2, U2AF1, ZRSR2), BCOR, and RUNX1, as well as MLL rearrangement, EVI1 overexpression in complete morphologic remission; or 3. Acute myeloid leukemia with a white blood cell count of greater than or equal to 50,000/mcL at presentation in first complete morphologic remission; or 4. Acute myeloid leukemia in first complete morphologic remission, having required more than one course of induction chemotherapy to attain remission status; or 5. Acute myeloid leukemia, all types, excluding M3 (Promyelocytic leukemia) in second or higher complete morphologic remission; or 6. Myelodysplastic syndromes (intermediate-2, high risk and chronic myelomonocytic leukemia (CMML) with bone marrow blasts <5%); or 7. Secondary acute myeloid leukemia on the basis of prior MDS or prior myeloproliferative neoplasm (MPN) in complete morphologic remission - Life expectancy not severely limited by concomitant disease - Karnofsky Performance Score greater than or equal to 70%. - Adequate organ function as defined below: Serum Bilirubin:<2.0 mg/dL; Alanine Aminotransferase (ALT) (SGPT): <3 x upper limit of normal; Creatinine Clearance:>60 mL/min (eGFR as estimated by the modified Modification of Diet in Renal Disease Study (MDRD) equation) - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Evidence of chronic active hepatitis or cirrhosis - HIV infection - Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown. - There are no prior therapies or concomitant medications that would render the patients ineligible |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease Free Survival at 1 Year Post-transplant | Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 1 year post-transplant. | 1 year post-transplant | |
Secondary | Disease Free Survival at 6 Months Post-transplant | Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 6 months post-transplant | 6 months post-transplant | |
Secondary | Disease Free Survival at 2 Years Post-transplant | Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 2 years post-transplant. | 2 years post-transplant | |
Secondary | Overall Survival at 6 Months Post-transplant | Number of participants alive at 6 months post-transplant | 6 months post-transplant | |
Secondary | Overall Survival at 1 Year Post-Transplant | Number of participants alive at 1 year post-transplant | 1 year post-transplant | |
Secondary | Overall Survival at 2 Years Post-Transplant | Number of participants alive at 2 years post-transplant | 2 years post-transplant | |
Secondary | Graft Failure | Number of patients who experience graft failure, defined as the absence of neutrophil engraftment by Day +21 or a drop in the absolute neutrophil count to <0.3 cells/microL for five consecutive days occurring after initial neutrophil engraftment within the first 3 weeks post-transplantation. | 21 days post-transplant | |
Secondary | Acute Graft-versus-Host Disease (GVHD) | Number of patients who develop acute graft-versus-host disease of any grade. | 2 years post-transplant | |
Secondary | High-Risk Extensive Chronic Graft-versus-Host-Disease | Number of patients who develop high-risk extensive chronic graft-versus-host disease. Extensive chronic GVHD is defined as generalized skin or multiple organ involvement. High risk chronic GVHD is defined as platelet count of less than 100k/microL | 2 years post-transplant |
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