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Clinical Trial 19239
Interventions:Ipilimumab; Yervoy (Ipilimumab); decitabine (5-aza-2'-deoxycytidine)
Study Type: Treatment
Phase of Study: Phase I
- Kendra Sweet
A Phase 1 Study of Ipilimumab in Combination with Decitabine in Relapsed or Refractory Myelodysplastic Syndrome/Acute Myeloid Leukemia
This phase I trial studies the side effects and best dose of ipilimumab when given together with decitabine in treating patients with myelodysplastic syndrome or acute myeloid leukemia that has returned after a period of improvement or does not respond to treatment. Monoclonal antibodies, such as ipilimumab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ipilimumab and decitabine may work better in treating patients with relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia.
1.1 Primary Objectives: To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of combination decitabine and ipilimumab for relapsed or refractory MDS or relapsed or refractory AML in patients who are post allogeneic hematopoietic stem cell transplant (allo-HCT). To determine the MTD or RP2D of combination decitabine and ipilimumab for relapsed or refractory MDS or relapsed or refractory AML in patients who are transplant naive. 1.2 Secondary Objectives: To observe and record anti-tumor activity. Although the clinical benefit of this novel combination has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. To determine the overall response rate (ORR) including complete remission (CR) and complete remission with incomplete count recovery (CRi) for AML following 2003 IWG response criteria . To determine the ORR including CR, partial remission, marrow CR, hematologic improvement for MDS using 2006 IWG criteria . To determine the overall survival and progression free survival at 1 year. To determine the duration of remission. To capture the incidence and severity of acute graft-versus-host disease (GVHD) in the post allo-HCT cohort. To capture the incidence and severity of chronic graft-versus-host disease (GVHD) in the post allo-HCT Cohort 1.3 Exploratory Objectives: To measure the absolute lymphocyte count (ALC) prior to treatment and during treatment. We will compare changes in ALC between responders and non-responders given evidence that ALC after two cycles may be a predictor of clinical response in solid tumors. To evaluate the genome for evidence of clonal evolution among longitudinal samples (prior to treatment, during treatment, and at relapse if relevant) from individual patients. We will compare leukemic genotypic patterns among responders and non-responders. To evaluate the histopathologic findings of immune response using immunohistochemistry. To determine the immune response in the AML tumor microenvironment by using flow cytometry and single cell mass cytometry to evaluate T cell subsets. We will evaluate cytokine and chemokine panels. We will further evaluate the gene expression patterns of immune infiltrates. We will evaluate for alterations in antigen presenting cells in response to decitabine and combination therapy. We will evaluate for resistance to immune response due to STAT3 activation.