Early Access Program for Moxetumomab Pasudotox in Treating Relapsed or Hard-to-Treat Hairy Cell Leukemia

Sponsor: AstraZeneca

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03501615

Provider View

This program offers early access to the drug moxetumomab pasudotox for patients with hairy cell leukemia that has returned or is not responding to treatment. It is available for adults who meet specific health criteria.

Patient Parameters

Program Overview

This program is designed to provide access to moxetumomab pasudotox for adults with hairy cell leukemia that has come back or is not responding to other treatments. Patients will receive the drug on Days 1, 3, and 5 of each 28-day cycle, for up to 6 cycles, or until their disease progresses, they start another treatment, or they experience unacceptable side effects.

Description

This multi-center program allows eligible patients with relapsed or refractory hairy cell leukemia to receive moxetumomab pasudotox. To participate, patients must be at least 18 years old, have good organ function, and not have been treated with Pseudomonas-immunotoxin before. The treatment involves administering moxetumomab pasudotox on specific days within a 28-day cycle, continuing until a complete response is documented, for up to 6 cycles, or until the disease progresses, another treatment is started, or side effects become unacceptable.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with hairy cell leukemia or a variant that requires treatment due to low blood counts or enlarged spleen.
  • Not previously treated with Pseudomonas-immunotoxin.
  • Have had at least two prior treatments, including specific chemotherapy or targeted therapy.
  • Aged 18 years or older.
  • In good general health with a performance status of 0 to 2.
  • Have adequate organ function based on specific blood tests.
  • Able to understand and sign a consent form.
  • Expected to live at least 6 more months.
  • Women of childbearing potential must use effective birth control during and after the study.

Exclusion Criteria

  • Recent chemotherapy, immunotherapy, or radiotherapy within the last 4 weeks.
  • Currently taking other experimental drugs.
  • Known brain cancer spread.
  • Eye problems identified during screening.
  • Pregnant or breastfeeding women.
  • Active hepatitis B infection unless controlled with medication.
  • Another active cancer requiring treatment.
  • Uncontrolled health issues like infections or heart problems.
  • HIV-positive unless well-controlled with medication.
  • History of bone marrow transplant.
  • History of blood clotting disorders.
  • Severe lung problems or low oxygen levels.
  • Low blood protein levels.
  • Recent radioimmunotherapy.
  • Very low blood cell counts unless due to the disease.
  • Severe lung function impairment.
  • History of specific blood vessel disorders.
  • Abnormal heart rhythm on ECG.
  • High-dose estrogen use.
  • Severe blood clotting disorder.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.