2022-502790-42-00招募中2 期
Pilot-trial of methotrexate, tafasitamab (Minjuvi®), lenalidomide (Revlimid®) and rituximab in patients ineligible for HCT-ASCT with primary central nervous system lymphoma (PCNSL) -MTR²
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Efficacy will be determined using the complete response rate (CRR) after at least 2 cycles of treatment with MTR² (Methotrexate, Tafasitamab, Rituximab, Revlimid), as determined by independent review committee (IRC) and according to International Primary CNS Lymphoma Collaborative Group (IPCG) criteria
研究概览
简要总结
to estimate the efficacy of the Methotrexate, Tafasitamab, Rituximab, Revlimid (MTR²) regimen, to develop a feasible and effective regimen for the treatment of PCNSL patients who are unable to receive intensice induction and consolidation therapies.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18-69 years with ECOG PS ≥2 or ≥70 years ineligible for HCT-ASCT as per investigators discretion
- •Previously untreated, histologically (or cytologically) confirmed diagnosis of primary B-cell lymphoma of the central nervous system (PCNSL) by local pathologist. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy
- •At least one measurable lesion
- •Adequate organ function: o Adequate kidney function, defined as: Serum creatinine estimated glomerular filtration rate (MDRD) ≥ 60 ml/min o Adequate hepatic function, defined as: ALAT and ASAT ≤ 3 ULN Bilirubin ≤ 2.0 mg/dl (except for Meulengracht disease) o Adequate bone marrow function, defined as: White blood cell (WBC) count ≥ 3000/µL or absolute neutrophil count (ANC) ≥ 1000/µL Platelets ≥ 50.000/µL Hemoglobin > 8.0 g/dl o Adequate cardiac function, defined as: Cardiac ejection fraction ≥ 40% o Adequate pulmonary function as per investigators discretion
- •Written, signed, and dated informed consent for the trial provided by the participant
- •Female persons are eligible to participate if they are post-menopausal or females of no childbearing potential or if they agree to use a method of contraception considered safe as described in Section12.1.2.1
- •Male persons with female partners of childbearing potential are eligible to participate if they agree to contraceptive methods as described in Section 12.1.2.2
排除标准
- •Prior treatment for PCNSL with the exception of a pre-phase treatment comprising steroid treatment and / or single application of rituximab 375 mg/m2 and methotrexate 3.5 g/m2
- •Severe active infection
- •Congenital or acquired immunodeficiency including previous organ transplantation
- •Pregnant or nursing (lactating) women
- •Lack of accountability and inability to appreciate the nature, meaning and consequences of the trial and to formulate their own wishes correspondingly
- •Non-compliance, for reasons including, but not limited to the following: a. Increased alcohol consumption, Ddrug dependency or substance abuse that would interfere with cooperation with requirements of the trial b. Refusal of blood products during treatment c. Any similar circumstances that appear to make protocol treatment or long-term follow-up impossible
- •Relationship of dependence or employeremployee relationship to the sponsor or the investigator
- •Systemic lymphoma manifestation outside the CNS
- •Diagnosis of previous Non-Hodgkin lymphoma at any time
- •Primary vitreoretinal or leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord
- •HIV infection of any stage as determined by presence of anti-HIV antibodies (confirmatory test) and / or presence of RNA confirmed by PCR
- •Previous or concurrent malignancies with the following exceptions: a. Surgically cured carcinoma in-situ b. Other kinds of cancer without evidence of disease for at least 5 years
- •Hypersensitivity to study treatment or any component of the formulation
- •Stomatitis or gastrointestinal ulcerations preventing the use of methotrexate
- •Hepatitis B, hepatitis C or hepatitis E infection as determined by PCR
结局指标
主要结局
Efficacy will be determined using the complete response rate (CRR) after at least 2 cycles of treatment with MTR² (Methotrexate, Tafasitamab, Rituximab, Revlimid), as determined by independent review committee (IRC) and according to International Primary CNS Lymphoma Collaborative Group (IPCG) criteria
Efficacy will be determined using the complete response rate (CRR) after at least 2 cycles of treatment with MTR² (Methotrexate, Tafasitamab, Rituximab, Revlimid), as determined by independent review committee (IRC) and according to International Primary CNS Lymphoma Collaborative Group (IPCG) criteria
次要结局
- Best overall response rate (BORR) after 4 cycles of MTR² is defined as the rate of patients having achieved a CR or PR according to at least one post-baseline tumor assessment
- Objective response rate (ORR) at RA I and RA II defined as rate of patients showing CR, CRr or PR
- Progression-free survival (PFS) will be calculated for each patient as time between the start of treatment with MTR2 and the date of first progression, relapse or death or, in cases of continuing response, the date of the last documented follow-up . One-year PFS rates and 90% confidence intervals will be estimated using the Kaplan-Meier method.
- Overall survival (OS) will be calculated for each patient as time between the start of treatment with MTR² and the date of death or the date of the last documented followup (FU-eCRF, QoL CRF or written medical report). One-year OS rates and 90% confidence intervals will be estimated using the Kaplan-Meier method.
- Incidence and severity of adverse events, including toxic deaths during induction therapy will be summarized based on CTCAE grades
- Quality of life and neurocognitive impairment over time as determined by EORTC QLQC30 and BN20 questionnaires as well as Montreal Cognitive Assessment (MoCA), respectively
- Safety as determined by incidence and severity of adverse events
- Feasibility as determined by proportion of patients completing 4 cycles of MTR2 and relative dose intensity of planned and administered cycles
研究者
Peter Borchmann
Scientific
University Of Cologne
研究点 (8)
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