Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma (NCT00099255) | Clinical Trial Compass
CompletedPhase 2
Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma
United States40 participantsStarted 2004-09
Plain-language summary
This multi-center, phase II study will be conducted to define the toxicity profile and antitumor activity of SGN-30 in patients with pcALCL and other closely related lymphoproliferative disorders.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Patients must have a definite diagnosis.
* Patients must be histologically confirmed CD30 positive within 3 months of enrollment
* Patients with pcALCL must have target lesions present for at least 1 month without spontaneous regression
* pcALCL patients must have failed treatment with local radiation therapy, or failed systemic therapy of a single agent
* Patients must be considered an eligible candidate for systemic therapy as determined by the investigator
* All patients must have a three week wash-out from previous treatments, unless in the opinion of the investigator it is not in the best interest of the patient, at which point the individual case must be discussed with the medical monitor prior to enrollment.
* Patients must have an ECOG performance status of \< 2 (Appendix B) and a life expectancy \> six months.
* Patients must be at least 18 years of age.
* Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
* Females of childbearing potential must have a negative HCG pregnancy test result within three days of enrollment. All patients must agree to use an effective contraceptive method during the course of the study.
* Patients must give written informed consent.
* Required baseline laboratory data: Absolute neutrophil count greater than or equal to to 1,000/mm3, Platelet count greater than or equal to 75,000/mm3, Serum bilirubin less than or equal to 1.5 times…
What they're measuring
1
To determine the objective response rate in patients with pcALCL, T-MF, and LyP
2
To determine the duration of response in patients treated with SGN-30