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A single-institution, randomized, phase III study for Lenalidomide plus ICE versus ICE in relapsed or refractory non - GCB diffuse large B cell lymphoma

A single-institution, randomized, phase III study for Lenalidomide plus ICE versus ICE in relapsed or refractory non - GCB diffuse large B cell lymphoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022909
Enrollment
Unknown
Registered
2019-05-01
Start date
2019-05-10
Completion date
Unknown
Last updated
2019-05-05

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

A:R-ICE
B:ICE

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old, ECOG performance status of 0, 1, or 2, Life expectancy of >12 weeks; 2. All patents are diagnosed as Relapse/Refractory non-GCB diffuse large B cell lymphoma by pathology and history; 3. Adequate hematologic and hepatic-renal function: Hemoglobin >=9 g/dl, Absolute neutrophil count >=1.5*10^9/L, Platelet count >=100*10^9/L, ALT = 12 months after the last chemotherapy; 7. Ability and willingness to comply with the study protocol.

Exclusion criteria

Exclusion criteria: 1. Refuse to provide the blood sample; 2. History of severe allergic or anaphylactic reactions to any drugs including the protocol; 3. All patients of reproductive potential refuse to use adequate methods of contraception during the treatment period and until >12 months after the last chemotherapy; 4. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease, uncontrolled diabetes mellitus, pulmonary disease or severe hepatic and renal dysfunction; 5. Serious infections; 6. Contraindications of radiotherapy and chemotherapy; 7. History of other malignancy; 8. Mental disorder.

Design outcomes

Primary

MeasureTime frame
ORR;CR;PR;SD;PD;

Secondary

MeasureTime frame
OS;PFS;EFS;

Countries

China

Contacts

Public ContactLiling Zhang

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

lily1228@sina.com+86 15871725926

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026