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A multicenter, One-arm, Open, Prospective study for Low-dose Lenalidomide plus Rituximab (Laili) Regimen in the treatment of Elderly or Relapsed/Refractory B-cell non-Hodgkin's Lymphoma

A multicenter, One-arm, Open, Prospective study for Low-dose Lenalidomide plus Rituximab (Laili) Regimen in the treatment of Elderly or Relapsed/Refractory B-cell non-Hodgkin's Lymphoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020022
Enrollment
Unknown
Registered
2018-12-11
Start date
2018-12-20
Completion date
Unknown
Last updated
2018-12-18

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

Conditions

B-cell non-Hodgkin's lymphoma

Interventions

Case series:low dose of lenalidomide and rituximab

Sponsors

The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 80 years old; (2) male and female; (3) diagnosed elderly or relapsed/refractory B-NHL; (4) elderly B-NHL refers to patients aged = 60 years; relapsed B-NHL refers to patients who relapse after at least 1 month of first-line treatment with complete remission (CR); refractory B-NHL means that CR cannot be achieved at any time during treatment, or part of the treatment process Disease progression (PD) during remission (PR), or early recurrence within 1 month after reaching CR; (5) Different types of non-high-invasive B-cell NHL, including Mantle cell Lymphoma, Follicular Lymphoma, Mucosa-associated Lymphoid tissue lymphoma, Marginal Zone Lymphoma, Small cell Lymphoma, Lymphoplasmacytic Lymphoma; (6) =60 years of age Diffuse large B-cell Lymphoma; (7) ECOG behavioral status score of 0 to 3 points (Appendix 4); (8) expected survival time = 3 months; (9) The heart function is basically normal (ECG, heart color ultrasound); (10) Liver and kidney function is basically normal: blood bilirubin = 35umol / L, AST / ALT is less than 2 times the upper limit of normal value, serum creatinine = 130umol/L; (11) not exposed to chemotherapyradiotherapy and other antineoplastons within 1 month; (12) without malignant tumors andserious infections; (13) signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Previously allergic to drugs included in the protocol or to drugs similar in chemical structure to the test drug; (2) non-relapsed/refractory B-NHL; (3) highly invasive B-NHL, including Burkitt's lymph Tumor or age-60 years of Diffuse large B-cell lymphoma; (4) in the course of chemotherapyradiotherapy and other antineoplastons; (5) pregnant, lactating women and women of childbearing age who are unwilling to take contraceptive measures; (6) serious activity infection; (7) Drug and long-term alcohol abuse; (8) psychotic episodes; (9) before Within 6 months, patients were associated with uncontrolled or severe cardiovascular disease, including myocardial infarction, grade III/IV heart failure as defined by the New York Heart Association (NYHA), uncontrolled angina, and clinically significant pericardial disease (Appendix 1, NYHA heart function classification) or cardiac amyloidosis; patients with clinically significant QTc interval prolongation (male > 450ms, female > 470ms), ventricular tachycardia (VT), heart Fibrillation (AF), heart block above II degree, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), symptomatic drug-treated coronary heart disease patients; (10) cardiac B-ultrasound display with end-diastolic pericardial fluid dark area width =10mm; (11) active bleeding; (12) new thrombosis, embolism, cerebral hemorrhage and other diseases or medical history in the past six months; (13) ALT / AST ?2.5×ULN orALT / AST ?5×ULN (previous liver invasion), STB?1.5×ULN,Scr?2.5×ULN; (14) The investigator determined that it is not suitable for participation in the test.

Design outcomes

Primary

MeasureTime frame
overall response rate;complete remission;part remission;

Secondary

MeasureTime frame
Duration of response;Progress-free surviva;

Countries

China

Contacts

Public ContactQingsong Yin

The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital

jnyinqingsong@163.com+86 13703904030

Outcome results

None listed

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