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Early Access Programme to provide treatment access to moxetumomab pasudotox for eligible patients with relapsed/refractory hairy cell leukemia
Full description
Multicentre Early Access Programme, designed to provide treatment access to moxetumomab pasudotox for eligible patients with relapsed/refractory hairy cell leukemia who are at least 18 years of age, have adequate organ function and are Pseudomonas-immunotoxin naïve. Patients will be administered moxetumomab pasudotox on Days 1, 3 and 5 of each 28-day cycle until documentation of CR or for up to 6 cycles, progressive disease (PD), initiation of alternate therapy or unacceptable toxicity.
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Inclusion criteria
Histologically confirmed HCL or HCL variant with a need for therapy based on at least one of the following criteria:
a neutrophils < 1.0x 109/L b platelets < 100 x 109/L c hemoglobin < 10 g/dL d symptomatic splenomegaly
Pseudomonas-immunotoxin naïve
At least 2 prior systemic therapies, including 2 courses of a PNA, or 1 course of either rituximab or BRAF inhibitor following a single prior course of PNA.
Age ≥ 18 years.
ECOG performance status ≤ 2
Adequate organ function as defined below:
Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) < 2.5 ULN, fibrinogen ≥ 0.5 lower limit of normal; if on warfarin, INR < 3.5, if on any other anticoagulation, PT < 2.5 x baseline
Ability to understand and the willingness to sign a written informed consent document.
Life expectancy ≥ 6 months.
Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception prior to study entry and for the duration of study participation, and must agree to continue using such precautions for 4 months after completion of moxetumomab pasudotox administration; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
Exclusion criteria
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Data sourced from clinicaltrials.gov
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