Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase I Study of the Safety and Feasibility of Azacitidine After Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome After Allogeneic Stem Cell Transplantation
This phase I trial studies the effects and safety of adding azacitidine (5-AzaC) to the standard of care (Soc) for patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after being treated with donor stem cell transplant. SoC includes giving an infusion of the donor's white blood cells (donor lymphocyte infusion or DLI) to boost the anticancer effects of the transplant. Giving 5-AzaC after DLI may alter the function of T-cells resulting in reduced incidence of graft versus host disease (GVHD) while maintaining the anticancer effects.
PRIMARY OBJECTIVES:
-To determine the Maximum Tolerated Dose (MTD) of 5-AzaC (azacitidine) when given after
chemotherapy and DLI in patients with AML/MDS who relapse after allogeneic stem cell
transplant.
SECONDARY OBJECTIVES:
- To determine the rate of Grades II-IV and III-IV acute GVHD (aGVHD) in first 100 days
after DLI.
- To determine the rates of complete remission (CR), partial remission, (PR) and complete
remission with incomplete count recovery (CRi), and overall response rate (CR+ CRi +
PR).
- To determine overall survival 100 days after DLI.
- To determine the effects of increasing dose of 5-AzaC on frequency and absolute number
of resting regulatory T-cells (rTregs) and activated Tregs (aTregs) at baseline, 7
days, 14 days, 21 days, and ~60 days after first dose of 5-AzaC.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
| Terminated |
NCT04313881 -
Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
|
Phase 3 | |
| Recruiting |
NCT05088356 -
Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
|
Phase 1 | |
| Recruiting |
NCT04003220 -
Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
|
||
| Completed |
NCT02916979 -
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
|
Phase 1 | |
| Active, not recruiting |
NCT03755414 -
Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
|
Phase 1 | |
| Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
| Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
| Terminated |
NCT04866056 -
Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04701229 -
Haploinsufficiency of the RBM22 and SLU7 Genes in Del(5q) Myelodysplastic Syndromes
|
||
| Suspended |
NCT04485065 -
Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
|
Phase 1 | |
| Recruiting |
NCT04174547 -
An European Platform for Translational Research in Myelodysplastic Syndromes
|
||
| Enrolling by invitation |
NCT04093570 -
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
|
Phase 2 | |
| Completed |
NCT02508870 -
A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes
|
Phase 1 | |
| Completed |
NCT04543305 -
A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies
|
Phase 1 | |
| Recruiting |
NCT05384691 -
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
|
Phase 2 | |
| Recruiting |
NCT05365035 -
A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts
|
Phase 2 | |
| Recruiting |
NCT06008405 -
Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination Therapy
|
Phase 1 | |
| Not yet recruiting |
NCT05969821 -
Clonal Hematopoiesis of Immunological Significance
|
||
| Withdrawn |
NCT05170828 -
Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
|
Phase 1 |