[Clinical trials of new antitumor drugs in hematopoietic malignancies]

Although there is general agreement regarding the overall research goals of clinical trials of new antitumor drugs, there is a difference between the goal for chemotherapy sensitive tumors such as hematopoietic malignancies or germ cell tumors and the insensitive tumors such as most solid tumors. Hematopoietic malignancies like leukemia or malignant lymphoma are highly responsive to chemotherapy, approximately 70% of patients can reach complete remission, and some can survive for a long time. Furthermore, hematopoietic malignancies have a low incidence and the disease progresses rapidly. In this situation, clinical trials of new drugs for hematopoietic malignancies should be designed in the most efficient and ethically appropriate way. In this paper, we reviewed the recent clinical trials of new drugs for acute leukemia or malignant lymphoma. On the basis of these reviews, we proposed a frame-work that may improve the protocol design and address the ethical issues of phase studies for the development of new drugs for hematopoietic malignancies.