The randomized controlled trial of the R-THP-COP therapy (14 days) versus R-CHOP therapy (14 days) for treatment of patients under the age of 70 with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study

The randomized controlled trial of the R-THP-COP therapy (14 days) versus R-CHOP therapy (14 days) for treatment of patients under the age of 70 with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study - The randomized controlled trial of the R-THP-COP therapy (14 days) versus R-CHOP therapy (14 days) for treatment of patients under the age of 70 with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007283

Enrollment

Registered

2012-02-13

Start date

2008-07-01

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

diffuse large B-cell lymphoma

Interventions

R-THP-COP therapy (14 days) R-CHOP therapy (14 days)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who have been aounced as non-Hodgkin lymphoma. 2)Patients with histologically confirmed diffuse large B-Cell lymphomas (WHO classification 2008) 3)Patients with CD20-positive non-Hodgkin lymphoma on immunohistochemistry or flowcytometry. 4)Ann Arbor Stage:II, III, IV 5)Patients must have measurable disease. 6)Patients who were not previously treated. 7)Patients aged from 18 to 70 years old 8)ECOG performance status 0-3 9)Life expectancy greater than 4 months. 10)Patients must have normal marrow and organ function as defined below 10-1) Bone marrow function Absolute neutrophil count >= 1000/mm3 Platelet count >= 50,000/mm3 Hemoglobin >= 8.0 g/dL 10-2) Liver funciton AST, ALT <= 2.5 x ULN ALP <= 2.5 x ULN Total bilirubin <= 1.5 x ULN 10-3) Renal function Serum creatinine <= 2.0 x ULN 10-4) Cardiac function Normal electrocardiogram and cardiac function (without severe heart failure or cardiac arrhythmia) 11)Patients who give a written informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients with HIV or HTLV-1. 2)Patients with uncontrolled intercurrent illness including, but not limited to, malignant hypertension, congestive heart failure, coronary insufficiency, a new onset of myocardial infarction within 3 months , liver cirrhosis, uncontrolled hyperglycemia, renal failure, pulmonary fibrosis, or bleeding tendency. 3)Patients with another active malignancy 4)Patients who are pregnant or lactating, or have an intention to get pregnant 5)Patients with severe mental disease. 6)Patients who have had chemotherapy or radiotherapy prior to entering the study. 7)Patients who are judged inappropriate for the entry into the study by the principle doctor.

Design outcomes

Primary

Measure	Time frame
Remission rate	—

Secondary

Measure	Time frame
response rate, survival time, safety	—

Countries

Japan

Contacts

Public ContactHisashi Tsurumi

Gifu University Hospital First Department of Internal Medicine

htsuru@gifu-u.ac.jp058-230-6000

Outcome results

None listed

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