NCT00117845 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Poiesz BJ, Ruscetti FW, Gazdar AF, Bunn PA, Minna JD, Gallo RC
Detection and isolation of type C retrovirus particles from fresh and cultured lymphocytes of a patient with cutaneous T-cell lymphoma. Proc Natl Acad Sci U S A. 1980 Dec;77(12):7415-9.
Uchiyama T, Yodoi J, Sagawa K, Takatsuki K, Uchino H
Adult T-cell leukemia: clinical and hematologic features of 16 cases. Blood. 1977 Sep;50(3):481-92.
Yates AD, Morgan WT, Watkins WM
Linkage-specific alpha-D-galactosidases from Trichomonas foetus: characterisation of the blood-group B-destroying enzyme as a 1, 3-alpha-galactosidase and the blood-group P1-destroying enzyme as a 1, 4-alpha-galactosidase. FEBS Lett. 1975 Dec 15;60(2):281-5.

Phase II Study of the Efficacy and Toxicity of Ontak (Denileukin Diftitox) in the Therapy of Adult T-Cell Leukemia

Clinical trial NCT00117845 - References