Clinical Trials
Clinical Trial Detail
Return to search results.
Phase 1b Safety and Efficacy Study of TRU-016 and Rituximab in Previously Untreated Chronic Lymphocytic Leukemia
Complete title: A Phase 1b, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia
| Research Study Number | 2631.00 | ||
| Principal Investigator | John Pagel, MD, PhD | ||
| Phase | I |
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Diagnosis of CLL by IWCLL criteria and with Rai stage intermediate or high risk CLL
- No prior therapy for CLL
- At least one of the following criteria for active disease requiring treatment: progressive splenomegaly and/or lymphadenopathy; anemia or thrombocytopenia due to bone marrow involvement; or progressive lymphocytosis with an increase of >50% over a 2-month period or an unanticipated doubling time of less than 6 months
- Contraindication to chemotherapy as first-line therapy due to patient age, comorbidity or patient preference
- Age >/= to 18 years
- ECOG performance status of </= 2
- Life expectancy > 6 months in opinion of Investigator
- Serum creatinine, total bilirubin, ALT/SGPT </= 2.0 x upper limit of normal
- ANC >/= 800/mm3
- Platelets >/= 30,000/mm3
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Has received an investigational therapy within 30 days of first dose of study drug
- Previous or concurrent additional malignancy
- Clinically significant pulmonary dysfunction, active infection, prior allogeneic bone marrow transplant, active autoimmune disease
- Positive serology for HIV or hepatitis C
- Hepatitis B surface antigen or hepatitis B core antibody positive
- Pregnant or breastfeeding
- Known current drug or alcohol abuse
Other exclusion criteria may apply.
|
Keywords
Leukemia; Lymphoma; Lymphoproliferative Disease
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.
Please remember:
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.
- Diseases
& Research
- Treatment
& Support
- About Us
- Labs &
Projects
- Events &
Community Programs
- How You
Can Help Us
The Hutchinson Center's world-renowned scientists are discovering new ways to detect, prevent and treat cancer, HIV/AIDS and many other diseases.
- License Our Discoveries
The Hutchinson Center's world-renowned researchers work together to pursue lifesaving therapies that will help eliminate cancer and related diseases.
The Hutchinson Center's clinical research breakthroughs are delivered to patients through our treatment arm, the Seattle Cancer Care Alliance. This collaboration combines the strengths of the Hutchinson Center, UW Medicine and Seattle Children's.
You can help eliminate cancer and related diseases by attending Hutchinson Center events and participating in our other fundraising and community efforts.
- Divisions
The Hutchinson Center's pioneering researchers push the boundaries of science to find new ways to prevent, detect and treat cancer and related diseases.
Private support is critical to fund new research ideas and innovations, accelerating our ability to make lifesaving discoveries.
