Phase II study of R-CODOX-M/R-IVAC therapy for the patients with newly diagnosed primary mediastinal large B-cell lymphoma

Phase II study of R-CODOX-M/R-IVAC therapy for the patients with newly diagnosed primary mediastinal large B-cell lymphoma - PMBL-R-CODOX-M/R-IVAC-P2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003793

Enrollment

Registered

2010-06-22

Start date

2007-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary mediastinal large B-cell lymphoma

Interventions

Treatment regimen consisted of alternating cycles of R-CODOX-M (rituximab, cyclophosphamide, vincristine, doxorubicin, and methotrexate) and R-IVAC (rituximab, ifosfamide, etoposide, and cytarabine) f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histological diagnosis of primary mediastinal large B-cell lymphoma, according to the WHO classification. 2) Newly diagnosed, previously untreated primary mediastinal large B-cell lymphoma (patients who received corticosteroids alone are eligible for this study). 3) Positive for CD20 in lymphoma cells by immunohistochemistry or flowcytometry. 4) Age 18-59 years. 5) Performance status (ECOG): 0-2. 6) Having evaluable lesion. 7) No major organ dysfunction. 8) Patient's written informed consent before registration.

Exclusion criteria

Exclusion criteria: 1) Uncontrollable hypertension. 2) History of myocardial infarction or angina or cardiomyopathy. 3) HBs antigen positive, HCV antibody positive or HIV antibody positive. 4) Accompanying interstitial pneumonitis, pulmonary fibrosis, or severe emphysema (all apparently diagnosed by chest X-ray). 5) Severe infections. 6) Liver cirrhosis, either biopsy proven or clinically diagnosed. 7) Active double cancer: overlapping cancer or asynchronous cancer within 5 years. Carcinoma in situ, intramucosal cancers, and other equivalent lesions are not included for the active double cancer. 8) Women during pregnancy, lactation period or of childbearing potentials not using a reliable contraceptive method. 9) Use of major tranquilizer, antidepressant or antimanic, or severe psychosis. 10) History of allogeneic or autologous hematopoietic stem cell transplantation.

Design outcomes

Primary

Measure	Time frame
Complete response rate	—

Secondary

Measure	Time frame
Progression-free survival, overall survival, incidence of adverse events, and utility of response criteria with FDG-PET/CT	—

Countries

Japan

Contacts

Public ContactDai Maruyama

National Cancer Center Hospital Hematology Division

dmaruyam@ncc.go.jp81-3-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026