Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Histologically or cytologically confirmed relapse of AML, MDS or MPN (CMML or myelofibrosis or MDS/MPN with ≥5% blasts in the marrow).
- - Relapse at ≥2 months after any 8/8 or better HLA-matched HCT.
- - Available original stem cell donor.
- - Age ≥18 years.
- - ECOG performance status ≤2 (Karnofsky performance status ≥60, see Appendix A).
- - Recipient donor T cell chimerism ≥20% within 4 weeks prior to cell infusion.
- - <50% bone marrow involvement within 4 weeks prior to cell infusion.
- - No systemic corticosteroid therapy for GVHD (≤5 mg of prednisone or equivalent doses of other systemic steroids for non-GVHD, non-autoimmune indications for at least 4 weeks prior to cell infusion).
- - No other systemic medications/treatments (e.g. ECP) for GVHD for at least 4 weeks prior to cell infusion.
- - Ability to understand and willingness to sign written informed consents.
- - Adequate organ function as defined below: - Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then < 3 x ULN) - AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN.
- - creatinine clearance: ≤1.5 x institutional ULN.
- - O2 saturation: ≥90% on room air.
- - LVEF >40% - The effects of CD25/Treg-depleted DLI and Ipilimumab on the developing human fetus are unknown.
- - Negative pregnancy test for females of childbearing potential only.
- - Extramedullary relapse involving immuno-privileged sites (e.g. CNS, testes, eyes).
- - Participants who have had anti-tumor chemotherapy or other investigational agents within 4 weeks prior to cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 8 weeks prior, or those who have not recovered from adverse events due to agents administered more than 4 weeks prior.
- - Prior history of DLI.
- - Prior history of treatment with anti-CTLA-4 or anti-PD-1 pathway therapy, or CD137 agonist therapy.
- - Prior history of severe (grade 3 or 4) acute GVHD, or ongoing active GVHD requiring systemic treatment.
- - Organ transplant (allograft) recipient.
- - History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ipilimumab or other agents used in study.
- - Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).
- - Uncontrolled intercurrent 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 women are excluded from this study because of the unknown teratogenic risk.
- - HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with agents used in this study.
- - Individuals with active uncontrolled hepatitis B or C are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after HCT.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Dana-Farber Cancer Institute|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|John Koreth, MD|
|Principal Investigator Affiliation||Dana-Farber Cancer Institute|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia, Myelofibrosis|
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has not approved ipilimumab for this specific disease but it has been approved for other uses. This drug has been used in other research studies and is now FDA-approved for the treatment of melanoma. Many people have also received ipilimumab on research studies for possible treatment of prostate cancer, lymphoma, kidney cancer, ovarian cancer and HIV infection. Information from those other research studies suggests that ipilimumab may help to treat the participant's cancer. Ipilimumab is an antibody that acts against CTLA-4. An antibody is a common type of protein produced by the body that the immune system (a system that defends the body against potentially harmful particles) uses to find and destroy foreign molecules (particles not typically found in the body) such as bacteria and viruses.
Experimental: CD25/Treg-depleted DLI + Ipilimumab
Ipilimumab is administered intravenously every 12 weeks Patients will receive a defined dose of CD25hi Treg depleted DLI intravenously
Drug: - Ipilimumab
Ipilimumab is an antibody that acts against CTLA-4
Biological: - CD25hi Treg depleted DLI
Donor lymphocyte product
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.