EUCTR2005-004977-12-SI进行中（未招募）不适用
A Phase IIIb study of MabThera® (rituximab) maintenance therapy in patients with follicular Non-Hodgkin’s Lymphoma who have responded to induction therapy. - MAXIMA
F. Hoffmann-La Roche Limited0 个研究点目标入组 500 人开始时间: 2006年6月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet all of the following criteria to be eligible for study entry:
- •1.Signed written informed consent form. (For Germany see also Section 17.11.1.1).
- •2.Histologically confirmed, CD20+, Grade 1, 2 or 3a follicular Non-Hodgkin’s lymphoma.
- •3.Patients must have received adequate induction therapy either as first line treatment or patients must have received adequate induction therapy as treatment for relapsed disease.
- •Adequate induction therapy is defined as treatment for a minimum of 8 cycles of rituximab either as monotherapy, or combined with induction chemotherapy. The time elapsed from the first to the last of the last 8 induction infusions should not exceed 30 weeks.
- •The type of chemotherapy and the number of cycles added to 8 cycles of rituximab is according to the investigator’s judgment (e.g., 6 x CVP + 8 x rituximab would be considered adequate for this study).
- •4.Patients must have a computerised tomography (CT) (or Positron Emission Tomography [PET] or Magnetic Resonance Imaging [MRI]) documented response to induction therapy: partial response (PR), complete response (CR) or unconfirmed complete response (CRu). Response assessment must be made within eight weeks of study entry. For lymphomas that cannot be measured by radiographic techniques (e.g. follicular lymphoma of the stomach) appropriate measurements replacing radiographic images need to be used (e.g. gastroscopy).
- •5.Induction therapy should have been completed to allow the first rituximab maintenance administration to occur eight to twelve weeks after day 1 of the last induction cycle (1 week before, or 2 weeks after, the period of eight to twelve weeks may be tolerated if these changes are due to documented administrative problems at the study site beyond the control of the site staff).
- •If patients are recovering from rituximab related toxicity from the most recent rituximab containing induction therapy, they may receive their first rituximab maintenance infusion up to six months after day 1 of the last cycle of induction therapy.
- •6.Patients must be = 18 years old.
- •7.Patients must have a performance status = 2 on the ECOG scale.
- •8.Adequate haematological function within 28 days prior to prior to their first rituximab maintenance infusion. This includes:
- •Haemoglobin = 8.0g/dL (5.0 mmol/L)
- •Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Platelets count = 100 x 109/L. (Lower platelet counts [= 50 x 109/L] are acceptable if low level is due to toxicity of previous chemotherapy and not accompanied by bleeding.)
- •9.Patients must have immunoglobulin of type G (IgG) levels = 2g/L within 28 days prior to their first rituximab maintenance infusion.
- •10.Agree to use effective contraception, and agree not to become pregnant during participation in the study or within 12 months after the last rituximab maintenance infusion. Men agree not to father a child during participation in the study or within 12 months after the last rituximab maintenance infusion. (For Germany see also Section 17.11.1.1)
- •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
排除标准
- •Patients with any of the following will be excluded from study entry:
- •1.Patients with poor compliance during induction therapy; judgment is up to investigators.
- •2.Patients who had significant delays / interruptions in their induction therapy such that completion of the planned rituximab therapy was more than four months longer than the planned schedule.
- •3.Stable disease (SD) or progressive disease (PD) after most recent induction therapy.
- •4.Transformation to high-grade lymphoma (secondary to low grade” follicular lymphoma).
- •5.Presence or history of central nervous system (CNS) lymphomatous disease (e.g., CNS lymphoma or lymphomatous meningitis).
- •6.Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 20 mg/day prednisone.
- •7.Patients with prior or concomitant malignancies other than a follicular non-Hodgkin’s lymphoma, except for non-melanoma skin cancer, adequately treated in situ cervical cancer, or patients who have had previous cancers if they are considered cured and there has been no evidence of recurrence in the last 3 years.
- •8.Major surgery (excluding lymph node biopsy) within 28 days prior to their first rituximab maintenance infusion.
- •9.Poor hepatic function: total bilirubin > 2.0 mg/dL (34 µmol/L), alanine-amino-transferase (ALT) > 3 x the upper limit of normal (ULN) unless these abnormalities are related to lymphoma.
- •10.Patients who have known Human Immuno-deficiency Virus (HIV) infection or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •11.Serious underlying medical conditions, which could impair the ability of the patient to participate in the study (e.g., uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease, uncontrolled hypertension or pre-existing cardiac condition). Judgment is up to the investigator.
- •12.Pregnant patients cannot enter the study. A negative serum pregnancy test is required for women of childbearing potential within seven days prior to first rituximab maintenance therapy infusion.
- •13.Breast-feeding patients are not permitted to enter the study.
- •14.Life expectancy of less than 6 months.
- •15.Known sensitivity or allergy to murine products. (For Germany see also Section 17.11.1.1)
- •16.Treatment within a clinical study within 30 days prior to study entry. (For Germany see also Section 17.11.1.1)
- •17.Patients unable to provide informed consent or patients under protection from a guardian. (For Germany see also Section 17.11.1.1)
- •18.Active infection requiring treatment, or chronic recurrent infection, e.g., osteomyelitis.
研究者
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