Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT00276159
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00276159
Study Brief:
Protocol Section:
NCT00276159