A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia
PhasePhase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.
Inclusion and Exclusion Criteria
- INCLUSION CRITERIA:
- Patients must have histologically confirmed hairy cell leukemia or hairy cell leukemia variant .with a need for therapy
- Patients must be Pseudomonas-immunotoxin naive
- Patients must have had at least 2 prior purine analogs, or at least 1 course of purine analog and 1 of either rituximab or BRAF inhibitor.
- Men or women age greater than or equal to 18 years.
- ECOG performance status less than or equal to 2.
- Patients must have adequate organ function EXCLUSION CRITERIA
- Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to entering the study.
- Patients who are receiving any other investigational agents.
- Patients with known brain metastases should be excluded from this clinical trial
- Patients with clinically significant ophthalmologic findings during screening
- Pregnant or breastfeeding females.
- Positive for Hepatitis B core antibody or surface antigen unless the patient is on Lamivudine or Entecavir and Hepatitis B Viral DNA load is less than 2000 IU/mL.
- Active second malignancy requiring treatment other than minor resection of indolent cancers like basal cell and squamous skin cancers
- HIV-positive patients unless taking appropriate anti-HIV medications with a CD4 count of greater than 200.
- History of allogeneic bone marrow transplant.
- Patients with history of both thromboembolism and known congenital hypercoagulable conditions.
- Uncontrolled pulmonary infection, pulmonary edema.
- Adequate oxygen saturation
- Radioimmunotherapy within 2 years prior to enrollment in study.
- Adequate hematologic function
- Adequate lung function
- Patients with history of thrombotic microangiopathy or thrombotic microangiopathy / hemolytic uremic syndrome
- Patients with QTc interval (Friderica) elevation > 500 msec based on at least 2 separate 12-lead ECGs
- Patient on high dose estrogen
- Patients with clinical evidence of disseminated intravascular coagulation
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.