Nivolumab and Ipilimumab After Donor Stem Cell Transplant in Treating Patients With High Risk Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed · Phase 1

Conditions studied: Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia

In brief

This phase Ib trial studies the side effects and best dose of nivolumab and ipilimumab after donor stem cell transplant in treating patients with high risk acute myeloid leukemia or myelodysplastic syndrome that does not respond to treatment or has come back. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key facts

Study ID: NCT03600155
Run by: M.D. Anderson Cancer Center
People needed: 29
Starts: 2018-10-11
Expected to finish: 2024-12-02
Last updated by the study team: 2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with evidence of relapsed or refractory AML or MDS following allogeneic stem cell transplantation
Patients must have received preparative regimens to include either busulfan- or melphalan-based regimens
Patient must have achieved myeloid engraftment as defined by an absolute neutrophil count >= 500 micro/L on 3 consecutive days
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Total bilirubin =< 2 times upper limit of normal (x ULN) (=< 3 x ULN if considered to be due to Gilbert's syndrome)
Aspartate aminotransferase or alanine aminotransferase =< 2.5 x ULN
Serum creatinine =< 2 x ULN or glomerular filtration rate (GFR) >= 50
Patients must provide written informed consent
The interval from the infusion of stem cells to time of initiation of nivolumab or ipilimumab will be at least 6 weeks (42 days)
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment
Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment

You may not qualify if…

Patients with known allergy or hypersensitivity to nivolumab or ipilimumab or any of their components
Patients with acute GVHD > grade 2 at any time during the post-transplant course
Patients with a known history of severe interstitial lung disease or severe pneumonitis or active pneumonitis that is uncontrolled in the opinion of the treating physician
Patients with a known history of any of the following autoimmune diseases are excluded:
Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis)
Patients with a history of rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis)
Patients with solid organ allografts (such as renal transplant) are excluded
Ongoing immunosuppressive therapy for the treatment of GVHD. Patients receiving GVHD prophylaxis will be allowed on this study
Patients with symptomatic central nervous system (CNS) leukemia at the time of evaluation or patients with poorly controlled CNS leukemia
Active and uncontrolled disease/(active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association [NYHA] class III/IV, clinically significant and uncontrolled arrhythmia) as judged by the treating physician
Patients with known human immunodeficiency virus seropositivity will be excluded
Known to be positive for hepatitis B by surface antigen expression. Known to have active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months)
Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator
Patients unwilling or unable to comply with the protocol
Pregnant or breastfeeding

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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