NCT00001271 - 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)

Shen GL, Li JL, Ghetie MA, Ghetie V, May RD, Till M, Brown AN, Relf M, Knowles P, Uhr JW, et al
Evaluation of four CD22 antibodies as ricin A chain-containing immunotoxins for the in vivo therapy of human B-cell leukemias and lymphomas. Int J Cancer. 1988 Nov 15;42(5):792-7.
Thorpe PE, Detre SI, Foxwell BM, Brown AN, Skilleter DN, Wilson G, Forrester JA, Stirpe F
Modification of the carbohydrate in ricin with metaperiodate-cyanoborohydride mixtures. Effects on toxicity and in vivo distribution. Eur J Biochem. 1985 Feb 15;147(1):197-206.
Vitetta ES, Fulton RJ, May RD, Till M, Uhr JW
Redesigning nature's poisons to create anti-tumor reagents. Science. 1987 Nov 20;238(4830):1098-104. Review.

A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma

Clinical trial NCT00001271 - References