Ipilimumab in Treating Patients With Relapsed Hematologic Malignancies After Donor Stem Cell Transplantation

Status: Recruiting
Phase: Phase 1
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT01822509 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-537

 

This phase I trial studies the side effects and the best dose of ipilimumab in treating patients with relapsed hematologic malignancies after donor stem cell transplantation. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Matthew Davids, MD, Dana Farber Cancer Institute

Site-responsible Investigators:
David Avigan, MD, Beth Israel Deaconess Medical Center
Yi-Bin Chen, MD, Massachusetts General Hospital

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Mildred Pasek, mpasek@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically confirmed hematologic malignancy - The following malignancies will be considered eligible if progressive or persistent: - Chronic Lymphocytic Leukemia (CLL) - Non-Hodgkin Lymphoma (NHL) - Hodgkin Lymphoma (HL) - Multiple Myeloma (MM) - Acute Leukemia (AML, ALL) - Myelodysplastic Syndrome (MDS) - Myeloproliferative Neoplasms (MPN) - Chronic Myeloid Leukemia (CML) - Must have undergone allogeneic hematopoietic stem cell transplantation (HSCT) (regardless of stem cell source) - Must be less than 3 years after withdrawal of all prophylactic immunosuppression - Must have baseline donor T cell chimerism of >= 20% - Life expectancy of greater than 3 months - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless due to Gilbert's disease or disease- related hemolysis, then =< 3.0 x ULN) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN - Creatinine =< 1.5 x institutional ULN - Must be off all immunosuppressive medications for at least 4 weeks prior to study entry - Ability to understand and the willingness to sign a written informed consent document - Men and women of all races and ethnic groups are eligible for this trial Exclusion Criteria: - Participants who have had anti-tumor therapy or other investigational agents within 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C), or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration - Patients with prior history of severe (grade 3 or 4) acute graft-versus-host disease (GVHD) - Patients with a history of prior treatment with ipilimumab, anti-programmed cell death protein 1 (PD 1) antibody, or cluster of differentiation (CD) 137 agonist therapy - Patients who have had donor lymphocyte infusion (DLI) within 8 weeks prior to registration - 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 (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's granulomatosis]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis); patients with Hashimoto's thyroiditis are eligible to go on study - Patients with known chronic human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections should be excluded because of potential effects on immune function and/or drug interactions - 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 ipilimumab is an immunomodulatory agent with the potential for teratogenic or abortifacient effects - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of ipilimumab administration
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