OHSU

IRB #

IRB00010274

Title

A Phase Ib Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of DCDS4501A in Combination with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients with B-Cell Non-Hodgkin’s Lymphoma

Principal Investigator

Andy Chen

Study Purpose

The purpose of this study is to see the effects, good or bad, the study drug DCDS4501A, in combination with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone, has in participants with Non-Hodgkin's Lymphoma. The study drug will be tested at increasing strengths until a tolerated dose is determined. That dose will then be used in a second stage of the study.

Medical Condition(s)

Non-Hodgkin's Lymphoma

Eligibility Criteria

Participants must have:
- B-cell Non-Hodgkin's Lymphoma (B-cell NHL): Patients with newly diagnosed B-cell NHL or relapsed/refractory B-cell NHL are eligible.
-No more than one treatment for B-cell NHL
- Or previously untreated patients with DLBCL
- Between 60 and 80 years old
- At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension determined by scans
- Life expectancy of at least 24 weeks
- Adequate routine blood test results:
Hemoglobin ≥ 9 g/dL
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
Platelet count ≥ 75 × 109/L
-Agreement to use adequate birth control methods
- Male participants must agree to abstain from sperm donation for at least 5 months after the last study drug dose

Participants must NOT have:
-Prior stem cell transplant
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- Contraindication to receive any of the individual components of R-CHP
- Current peripheral neuropathy
- Primary CNS lymphoma
- Vaccination with live vaccines within 6 months before starting study
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the participant
- Significant cardiovascular disease
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection within 4 weeks of starting study
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Presence of positive test results for hepatitis B (HBsAg and/or total anti-HBc) or hepatitis C (HCV antibody)
- Prior radiotherapy to the mediastinal/pericardial region
- Women who are pregnant or lactating
- Recent major surgery within 6 weeks before the start of study

Age Range

60 - 80

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive treatment for approximately 4 months and then return to clinic for follow up appointments every 3 months for the first year and every 6 months after that until his or her cancer gets worse.

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Genentech, Inc.

Recruitment End

12/18/2014

Compensation Provided

No


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