CLINICAL TRIAL SUMMARY

MDACC Study No:2012-0630 (clinicaltrials.gov NCT No: NCT01777152)
Title:A randomized, double-blind, placebo-controlled, phase 3 study
of brentuximab vedotin and CHP (A+CHP) versus CHOP in the
frontline treatment of patients with CD30-positive mature T-cell
lymphomas
Principal Investigator:Michelle A. Fanale
Treatment Agent:Cyclophosphamide; Doxorubicin; Prednisone; SGN-35; Vincristine
Study Status:Open
Study Description:The goal of this clinical research study is to compare the effectiveness and
safety of 2 chemotherapy combinations. Participants on this study will receive
either a standard combination called CHOP (cyclophosphamide,
hydroxydaunorubicin [doxorubicin], oncovin [vincristine], and prednisone), or
an investigational combination called A+CHP. A+CHP is similar to CHOP, but the
patient receives brentuximab vedotin instead of vincristine.

Brentuximab vedotin has 2 parts. The first part is designed to attach to a
protein called CD30. CD30 is found on some normal cells in the body’s immune
system and on some types of MTCL, such as anaplastic large cell lymphoma
(ALCL). The second part of brentuximab vedotin may kill the cancer cells that
the first part targeted.

Cyclophosphamide, doxorubicin, and vincristine are designed to stop cancer
cells from growing and/or dividing, which may cause the cells to die.

Prednisone is a corticosteroid that is similar to a natural hormone made by
your body. Prednisone is often given in combination with other chemotherapy to
treat cancer.

Hide details for General InformationGeneral Information

Disease Group:Lymphoma
Phase of Study:Phase III
Treatment Agents:Cyclophosphamide
Doxorubicin
Prednisone
SGN-35
Vincristine
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Seattle Genetics Inc.
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Michelle A. Fanale
Dept:Lymphoma
For Clinical Trial Enrollment:713-792-2806
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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