R-MPV-R-A EGA trial

JRCT ID: jRCTs061180093

Registered date:22/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Primary central nervous system lymphoma
• Date of first enrollment: 12/07/2019
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Dose modification of chemotherapy by G8 results

Outcome(s)

• Primary Outcome: Overall survival

Secondary Outcome

1) PFS (Relapse free survival).
2) TFFS (Treatment failure-free survival).
3) Response rate after R-MPV, response rate after radiotherapy, complete response rate after R-MPV, complete response rate after radiotherapy.
4) Development of adverse events, early deaths, treatment-related deaths, Grade 4 non-hematologic adverse events, proportion of MMSE non-worsening.
5) Completion of HD-MTX, completion of radiotherapy, completion of high dose Ara-C.

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically proven CD20 positive diffuse large B-cell lymphoma.
2) Lymphoma originating from the central nervous system except for the spinal cord. Existence of intraocular lymphoma a is eligible.
3) Both solitary/multiple lesions are eligible.
4) Both measurable/immeasurable lesions are eligible.
5) No evidence of lymphomatous meningitis confirmed by cerebrospinal fluid cytology or brain/whole spine MRI.
6) Postoperative date between 3 and 20 days.
7) Age 70-year-old or more.
8) ECOG PS 0-3, or PS 4 caused by neurological deficits associated with tumors.
Following cases are also eligible: PS 0-3 ameliorated by administration of corticosteroids, glycerol or mannitol.
9) No prior treatment with chemotherapy or cranial radio-therapy as treatment for other malignancies and malignant lymphoma.
10) No evidence of lymphoma outside the CNS and the eyes confirmed by CT scanning with contrast enhancement of the chest, abdomen and the pelvis.
11) Adequate organ function.
12) Written informed consent.

Exclude criteria

1) Concurrent malignancies (concurrent double cancer or metachronous cancer within 5 years) excluding basal cell carcinoma of the skin or cervical carcinoma in situ.
2) Previous history of lymphoma except for the CNS and the eyes.
3) Evidence of lymphomatosis cerebri.
4) Concurrent infectious diseases necessitate systemic treatment.
5) Body temprature equal to 38 degrees Celsius or more.
6) Starting treatment with corticosteroids before onset of this PCNSL.
7) Complication of uncontrolled diabetes mellitus or hypertension.
8) Evidence of unstable angina (onset within 3 weeks or deteriorating symptoms) or history of cardiac infarction within 6 months. EF is less than50%.
9) Patients with immune deficiency syndrome such as AIDS (HIV antibody positive), X-linked agammaglobulinemia, chronic granulomatous diseases or Wiskott-Aldrich Syndrome.
10) Concurrent psychiatric problems.
11) Concurrent pulmonary fibrosis or interstitial pneumonia.
12) Patients for whom both gadolinium and iodine contrast media cannot be applied because of allergy.

Related Information

• Primary Sponsor: Yamasaki Fumiyuki
• Secondary Sponsor: Department of Clinical Oncology & Neuro-oncology Program, Hiroshima University Hospital