A Phase I, Multicenter, Dose-Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Hairy Cell Leukemia
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Robert J. Kreitman, M.D.
Natasha Kormanik, R.N., B.S.N., O.C.N.
Elizabeth Maestri, R.N.
Joan Aaron, R.N., B.S.N., O.C.N.
Key Eligibility Criteria:
- Confirmed diagnosis of hairy cell leukemia (HCL)
- At least one of the following:
- Neutropenia (ANC < 1,000 cells/μL)
- Anemia (Hgb < 10 g/dL)
- Thrombocytopenia (Plt < 100,000/μL)
- Absolute lymphocyte count of > 20,000 cells/μL or symptomatic splenomegaly
- At least 2 prior systemic therapies (must have had at least 2 courses of purine analog, or 1 if response lasted < 2 years or unacceptable toxicity to purine analog)
- ECOG performance 0–2
- Life expectancy > 6 months
- ≥ 18 years of age
- Measurable disease
- No history of bone marrow transplant
- Must use approved method of contraception
- Patients with other cancers who have had < 5 years disease free considered on a case-by-case basis
- ALT, AST or bilirubin < grade 2 (unless due to Gilbert’s disease)
- Creatinine clearance > 60 mL/min
- ANC ≥ 1,000/cmm or platelet ≥ 50,000/cmm (unless due to underlying disease)
- No baseline coagulopathy ≥ grade 3 (unless due to anticoagulation therapy)
- FEV ≥ 50%
- DLCO ≥ 50%
- Pancytopenia ≥ grade 3 or erythropoietin dependence allowed, if due to disease, based on bone marrow studies
- No ongoing CNS involvement (prior CNS involvement allowed)
- Not pregnant or nursing
- No significant level of antibody to CAT-8015 or antibody that neutralizes the binding of CAT-8015 to CD22
- No standard or investigational therapy for 3 weeks prior to study entry (patients who have received or are receiving radiation therapy are not excluded, providing that the volume of bone marrow treated is < 10% and the patient has measurable disease outside the radiation port)
- ≤ 3 months since prior monoclonal therapy
- No history of pseudomonas-exotoxin immunotoxin (PE)
- HIV negative
- No hepatitis B surface antigen positivity
- No uncontrolled, symptomatic illness including but not limited to:
- Infections requiring systemic antibodies
- Congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness
- Social situations limiting compliance with study requirements
This is a standard, 3+3 dose-finding study with an expanded maximum tolerated dose (MTD) cohort.
- Cohorts of 3 patients each will receive escalating doses of CAT-8015 until the maximum tolerated dose (MTD) is determined
- Once the MTD is determined, the MTD cohort will be expanded to 12 patients; MTD is defined as the dose level at which ≤ 1 of 6 patients experience DLT or the dose level immediately below the level at which > 1 out of 2–6 patients experience DLT
- Patients receive CAT-8015 every 4 weeks for a total of 10 cycles until progressive disease or until they become otherwise ineligible
- CAT-8015 will be given intravenously (IV) on Days 1, 3, and 5 of each cycle
- Dose escalation to a new cohort may not occur until authorized by the medical monitor, which will require that all patients from the prior cohort have reached Cycle 2, Day 10 without DLT if eligible for retreatment
- Disease assessment will be completed prior to the first cycle of CAT-8015, prior to Cycle 2, and prior to every other subsequent cycle and at post-treatment follow-up visit
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.