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A Prospective, Single-Arm, Phase II Clinical Study of RP Regimen in Previously Untreated Indolent B-Cell Lymphoma

A Prospective, Single-Arm, Phase II Clinical Study of RP Regimen in Previously Untreated Indolent B-Cell Lymphoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106326
Enrollment
Unknown
Registered
2025-07-22
Start date
2025-07-22
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Lymphoma

Interventions

Treatment group:Rituximab + Pomalidomide (RP)

Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Gender: No restriction; Age: >=60 years; or =1 criterion required): (1) Hemoglobin 10 cm), or massive splenomegaly (>=6 cm below left costal margin); (4) B symptoms: Fever >38°C (persistent/recurrent for 2 weeks, non-infectious), night sweats, or >10% weight loss in 6 months; (5) Rapid progression (e.g., lymphocyte doubling time =3 months.

Exclusion criteria

Exclusion criteria: 1. Diagnosis or treatment for malignancies other than B-NHL within the past year (including active central nervous system lymphoma); 2. Clinical evidence of transformation to large cell lymphoma or progression to prolymphocytic leukemia (PLL); 3. Non-lymphoma-related hepatic or renal impairment: Alanine aminotransferase (ALT) >3× upper limit of normal (ULN); Aspartate aminotransferase (AST) >3× ULN; Total bilirubin (TBIL) >2× ULN; Serum creatinine >1.5× ULN; 4. Other severe medical conditions that may interfere with the study (e.g., uncontrolled diabetes, gastric ulcers, significant cardiopulmonary diseases, etc.). Final determination is at the investigator's discretion. 5. Severe or uncontrolled infections; 6. Central nervous system involvement or clinically manifest neurological dysfunction; 7. Major surgery within the past 30 days (excluding lymph node biopsy); 8. Pregnant or lactating women, or women of childbearing potential not using contraception; 9. Known hypersensitivity to any study drugs.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Overall response rate, ORR;Complete response rate, CRR;Overall survival rate;Molecular biology remission rate;Duration of tumor remission;Treatment related side effects;

Countries

China

Contacts

Public ContactLi Zengjun

Shandong Cancer Hospital

zengjunli@163.com+86 136 4213 8692

Outcome results

None listed

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