Phase II study of safety and efficacy of alternating R-CHOP and R-HDMA therapy in high-risk diffuse large B-cell lymphoma

Phase II study of safety and efficacy of alternating R-CHOP and R-HDMA therapy in high-risk diffuse large B-cell lymphoma - Safety and efficacy of alternating R-CHOP and R-HDMA therapy in high-risk DLBCL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031459

Enrollment

Registered

2018-03-01

Start date

2018-03-01

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

8 courses of alternating R-CHOP and R-HDMA therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Histologically confirmed DLBCL 2 No previous chemotherapy 3 Evaluable disease 4 Confirmed to be CD20-positive lymphoma by flowcytometry or immunohistochemistry 5 Age: between 16 and 70 6 PS scale: between 0 and 2 7 Revised IPI; poor 8 No organ dysfunction; leukocyte count more than 2000/mm3, neutrophil count more thhan 1000/mm3, platelet count more than 10000/mm3, AST and ALT less than 150IU/L, total bilirubin less than 2.0 mg/dl, serum creatinine less than 2.0 mg/dl, SpO2 more than 93% (room air), normal ECG. 9 Obtaining written informed consent.

Exclusion criteria

Exclusion criteria: 1 Involvement of central nervous system 2 HBs antigen positive 3 HCV antibody positive 4 HIV antibody positive 5 Active synchronous malignancy 6 Patients who are pregnant, lactating, or possibly pregnant 7 Patients who receive steroid therapy for other diseases 8 Patients with uncontrolled infection 9 Severe allergy to drugs used in this study 10Patients who the researcher judged inappropriate as the subject

Design outcomes

Primary

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

Secondary

Measure	Time frame
2-year overall survival rate Response rate Adverse event Completion rate of protocol treatment Duration of therapy	—

Countries

Japan

Contacts

Public ContactKota Mizuno

Keio University School of Medicine Hematology Division

kota10@keio.jp03-3353-1211

Outcome results

None listed

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