Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

Summary: The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.

Detailed description: 852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability

Eligibility: Subjects are eligible for the study if they meet all of the following
  Inclusion Criteria:
  -  Diagnosis of one of the following hematologic malignancies not responding to at least 2 standard treatment regimens. Any criteria for persistent or recurrent disease acceptable, i.e. ≥5% blasts for acute leukemia.
  -  acute lymphoblastic leukemia (ALL)
  -  acute myeloid leukemia (AML)
  -  non-Hodgkin's lymphoma (NHL)
  -  Hodgkin's lymphoma (HL)
  -  multiple myeloma (MM)
  -  chronic lymphocytic leukemia (CLL)
  -  Performance status - Karnofsky > 50% for patients > 10 years of age or Lansky >50% for patients < 10 year of age
  -  Normal organ function within 14 days of study entry
  -  If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. A female is considered to be of childbearing potential unless she has had her uterus removed, had a double oophorectomy, or has been amenorrheic for at least 6 months after chemotherapy
  Exclusion Criteria:
  -  Had/have the following prior/concurrent therapy:
  -  Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)
  -  Investigational drugs/agents within 14 days of first dose of 852A
  -  Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)
  -  Drugs known to induce QT interval prolongation and/or induce Torsades De Pointes unless best available drug required to treat life-threatening conditions
  -  Radiotherapy within 4 weeks of the first dose of 852A
  -  Hematopoietic cell transplantation 4 weeks of first dose of 852A
  -  Active infection or fever > 38.5°C within 3 days of first dose of 852A
  -  Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
  -  History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
  -  Uncontrolled intercurrent or chronic illness
  -  Active autoimmune disease requiring immunosuppressive therapy within 30 days
  -  Active hepatitis B or C with evidence of ongoing viral replication
  -  Hyperthyroidism
  -  Uncontrolled seizure disorder
  -  Active coagulation disorder not controlled with medication
  -  Pregnant or lactating
  -  Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas adequately treated
  -  Proven active central nervous system (CNS) disease
  -  Human Immunodeficiency Virus (HIV) positive
  -  Congenital long QT syndrome or abnormal baseline QTc interval (> 450 msec in males and > 470 msec in females) after Bazett's correction (QTc msec = QT msec / square root of the RR interval in seconds) on screening electrocardiogram (ECG).

Relevance to patient case: not relevant