Phase II study of rituximab containing induction chemotherapy (R-high-CHOP followed by CHASER) and high-dose chemotherapy (LEED) supported with auto-PBSCT for previously untreated patients with advanced mantle cell lymphoma(JCOG0406)

Phase II study of rituximab containing induction chemotherapy (R-high-CHOP followed by CHASER) and high-dose chemotherapy (LEED) supported with auto-PBSCT for previously untreated patients with advanced mantle cell lymphoma(JCOG0406) - Phase II study of rituximab containing induction chemotherapy (R-high-CHOP followed by CHASER) and high-dose chemotherapy (LEED) supported with auto-PBSCT for previously untreated patients with advanced mantle cell lymphoma(JCOG0406)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001220

Enrollment

Registered

2008-06-30

Start date

2008-06-01

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

newly diagnosed advanced mantle cell lymphoma

Interventions

Phase II study to investigate efficacy and safety of rituximab containing induction chemotherpy (R-high-CHOP/CHASER) followed by high-dose chemotherapy (LEED) with auto-PBSCT for the newly diagnosed p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) pathohistological proved mantle cell lymphoma 2) positive for cyclin D1 in cell nucleus by immunohisitochemical technich 3) positive for CD5 and CD20 in lymphoma cells by flowcytometric analysis or immunohistochemical analysis 4) age : 20-65 5) performance status (PS) of 0-2 6) clinical stage of II bulky, III, or IV 7) peripheral lymphoma cells <=10,000/mm3 8) no CNS involvement 9) evaluable lesion 10) no previous history of chemotherapy, radiation therapy, interferon and/or antibody 11) no major organ dysfunction 12) patient's written informed consent

Exclusion criteria

Exclusion criteria: 1) history of glaucoma 2) in-treatment diabetes mellitus with insulin, or uncontrollable diabetes mellitus 3) uncontrollable hypertension 4) treatemnt required coronary disease, myocardiopathy and/or heart failure, and/or in-treatment arrythmia 5) positibe test for HBs antigen 6) positive test for HCV antibody 7)positive test for HIV antibody 8) interstitial pneumonia, pulmonary fibrosis or severe pulmonaly emphysema 9) severe bacterial infection 10) active another neoplasm 11) pregnant woman, or possible pregnant woman, or lactating woman 12) psychological disease or psychological symptom that seems to bedisturbe to participate in clinical trial

Design outcomes

Primary

Measure	Time frame
2-year progression-free survival rate	—

Secondary

Measure	Time frame
progression-free survival (PFS), 5-year PFS rate, overall survival (OS), 2-year OS rate, 5-year OS rate,complete response rate (%CR), overall response rate(ORR), %CR and ORR after induction therapy, incidense of adverse events, incidense of secindary neoplasms	—

Countries

Japan

Contacts

Public ContactMichinori Ogura

JCOG0406 Coordinating Office Dept. of Hematology & Oncology, Nagoya Daini Red Cross Hospital

JCOG_sir@ml.jcog.jp052-832-1121

Outcome results

None listed

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