EUCTR2009-010777-20-FRActive, not recruitingPhase 1
A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin’s Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant
Astellas Pharma Global Development, Inc. (APGD)0 sites60 target enrollmentStarted: October 16, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •A subject is eligible for the study if all of the following apply:
- •1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved
- •written Informed Consent and privacy language as per national regulations (e.g.,
- •HIPAA Authorization for U.S. sites) must be obtained from the subject or legally
- •authorized representative prior to any study-related procedures (including
- •withdrawal of prohibited medication, if applicable).
- •2. Male or female subject aged 18 years or older at the Baseline Visit.
- •3. Any stage, histologically confirmed CD20-positive primary or transformed DLBCL,
- •grade 3 FL or MCL.
- •4. Ineligible for or have previously received an ASCT.
- •5. Relapsed following receipt of last dose of systemic chemotherapy or ASCT.
- •o Relapsed = Completed systemic chemotherapy or ASCT exhibiting at least
- •a PR that was maintained for at least 6 months following completion of the
- •6. At least one, but no more than 3 prior chemotherapy regimens, including one
- •anthracycline-based combination regimen.
- •oAny planned maintenance therapy should be considered as part of the
- •previous treatment regimen.
- •oAny preparative treatment (salvage chemotherapy, high-dose
- •chemotherapy, radiation therapy, etc.) should be included with the ASCT
- •as one treatment regimen.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status = 1 at the
- •Baseline Visit.
- •8. Life expectancy greater than 12 weeks at the Baseline Visit.
- •9. At least one measurable lesion = or equal to 1.5 cm in the longest transverse
- •diameter as assessed via Screening Period computed tomography (CT) scan.
- •10. The subject with a previous history of non-CD20+ B cell NHL malignancy is
- •eligible for this study only if the subject meets the following criteria for a cancer
- •o Subject having basal cell or squamous cell carcinoma of the skin or
- •carcinoma-in-situ of the cervix is eligible if he/she has had potentially
- •curative treatment anytime prior to enrollment.
- •o The subject has undergone potentially curative therapy for all prior
- •malignancies, and the subject has been considered disease free for at
- •least 5 years.
- •11. If the subject is female, she must be non-pregnant and non-lactating at the
- •Baseline Visit. All sexually active males and females of childbearing potential
- •must agree to use an adequate method of contraception (double barrier)
- •throughout the study period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •A subject will be excluded from participation if any of the following apply:
- •1. Use of any standard/experimental anti-lymphoma drug therapy, within 21 days of the Baseline Visit.
- •2. Use of systemic steroids within 5 days of the Baseline Visit.
- •o A subject receiving steroids at the time of the Baseline Visit is eligible as
- •long as the subject is receiving a biologic dose or has been on a stable,
- •non-biologic dose for at least 4 weeks prior to the first dose of YM155 and
- •plans on continuing to receive the stable, non-biologic dose during study
- •participation.
- •3. Prior allogeneic stem cell transplant (SCT).
- •4. Inadequate marrow, hepatic and/or renal function at the Baseline Visit defined as:
- •o Serum creatinine = 1.5 x upper limit of normal (ULN) or calculated serum
- •creatinine clearance < 60 mL/min.
- •o Absolute neutrophil count (ANC) = 1000/mm3.
- •o Platelet = 100,000/mm3.
- •o Alanine transaminase (ALT) and Aspartate transaminase (AST)
- •= 2.5 x ULN or = 5 x ULN if secondary to liver metastases.
- •5. Central nervous system (CNS) or leptomeningeal involvement by lymphoma as
- •determined by the Investigator through physical examination and medical history
- •review at the Baseline Visit.
- •6. The subject has significant and/or uncontrolled cardiac, renal, hepatic, or other
- •systemic disorders or significant psychological conditions at the Baseline Visit that
- •in the Investigator’s judgment would jeopardize subject enrollment or compliance
- •with the study procedures.
- •7. The subject has known human immunodeficiency virus (HIV), hepatitis B surface
- •antigen, or hepatitis C antibody.
- •8. The subject has been previously treated with YM155.
- •9. The subject has received other investigational therapy or procedures within 28
- •days prior to the first study drug administration.
Investigators
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