CLINICAL TRIAL SUMMARY

MDACC Study No:2012-0293 (clinicaltrials.gov NCT No: NCT01569750)
Title:A Phase 1b Study Combining Ibrutinib with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with CD20-Positive B-Cell Non-Hodgkin Lymphoma (NHL)
Principal Investigator:Yasuhiro Oki
Treatment Agent:Cyclophosphamide; Doxorubicin; PCI-32765; Prednisone; Rituximab; Vincristine
Study Status:Closed
Study Description:The goal of this clinical research study is to learn the highest tolerable dose
of PCI-32765 (ibrutinib) that can be given to patients with NHL in combination
with standard R-CHOP chemotherapy. The safety of these combinations will also
be studied.

Ibrutinib is designed to block a protein that may help blood cancer cells to
live and grow. This may kill the cancer cells or stop them from growing.

R-CHOP chemotherapy is made up of the following drugs:
Cyclophosphamide is designed to block cancer cells from dividing, which may
slow or stop their growth and spread throughout the body. This may cause the
cancer cells to die.
Doxorubicin is designed to stop the growth of cancer cells, which may cause the
cells to die.
Vincristine is designed to block cancer cells from dividing, which may slow or
stop their growth and spread throughout the body. This may cause the cancer
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.
Rituximab is designed to attach to cancer cells and damage them, which may
cause the cells to die.

Hide details for General InformationGeneral Information

Disease Group:Lymphoma
Phase of Study:Phase I
Treatment Agents:Cyclophosphamide
Doxorubicin
PCI-32765
Prednisone
Rituximab
Vincristine
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Janssen Research & Development
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Yasuhiro Oki
Dept:Lymphoma/Myeloma
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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