A Pharmaceutical Company Plans to Conduct a Study to Evaluate

A pharmaceutical company plans to conduct a study to evaluate the efficacy of the addition of a novel conjugated anti-CD22 monoclonal antibody (mAb) to frontline therapy in adults age 18-39 with newly diagnosed precursor B-cell acute lymphoblastic leukemia (ALL) .  Researchers will assess the adverse reactions associated with treatment with the anti-CD22 mAb.  A total of 1,200 patients newly diagnosed with CD22 positive B-cell ALL will be randomized to either frontline chemotherapy or intravenous infusion of the mAb given on days 1, 8, and 15.  All participants will undergo bone marrow aspirate and biopsy on day 28.  The study's primary outcome measure will be event-free survival, and its secondary outcome will include disease-free survival, overall survival, and complete response.  Which of the following best describes this type of study?

A) Preclinical study
B) Phase I clinical trial
C) Phase II clinical trial
D) Phase III clinical trial
E) Phase IV clinical trial

Correct Answer:

Verified

Unlock this answer now
Get Access to more Verified Answers free of charge

Access For Free