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A phase I/II clinical trail of recombinant chimeric human/murine anti CD20 monoclonal antibody in treatment of relapsed indolent CD20-positive B-cell non-Hodgkin Lymphoma.

A phase I/II clinical trail of recombinant chimeric human/murine anti CD20 monoclonal antibody in treatment of relapsed indolent CD20-positive B-cell non-Hodgkin Lymphoma.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042103
Enrollment
Unknown
Registered
2021-01-13
Start date
2016-03-17
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Non-Hodgkin's lymphoma

Interventions

Sponsors

Peking University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years of age with no gender limit; 2. The patients must be confirmed by pathological examination as CD20-positive B-cell relapsed follicular lymphoma (pathological grading as grade I, II, IIIA) or marginal zone B-cell lymphoma within half a year, and the single drug therapy with CD20 monoclonal antibody can be effective judged by investigators; 3. At least one measurable lesion: non-radiation injury, at least one of the 2 vertical diameters was > 1.5cm; 4. ECOG performance status score is 0-2 at the time of selection; 5. The interval from the last systematic anti-tumor treatment must be more than 4 weeks (if it was carmustine, the interval should be more than 6 weeks); 6. There must be no glucocorticoid treatment within 28 days, or the dosage of prednisone is no more than 20 mg / day for relieving symptoms other than lymphoma or lymphoma related symptoms; 7. Blood routine examination: WBC >= 3 x 10^9 / L; NEUT >= 1.5 x 10^9 / L; Hgb >= 80g / L; PLT >= 75 x 10^9 / L (except due to bone marrow involvement of lymphoma); liver function: TBIL <= 2 times of the upper limit of normal value; ALT or AST <= 2.5 times of the upper limit of normal value without liver invasion; ALT or AST <= 5.0 times of normal value under liver invasion; renal function: Cr <= 1.5 times of upper limit of normal value; 8. The expected survival time should be more than 3 months; 9. ADA is negative; 10. No live virus vaccine inoculated within 28 days before the treatment, and the virus live vaccine cannot be accepted util half a year after the last medication; 11. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who transform into higher grade lymphoma; 2. Patients with rituximab resistance (defined as: patients treated with rituximab based treatment have never obtained a efficacy >= PR, or disease progression occurs during rituximab treatment, or disease progression occurs within half a year after the drug withdrawal); 3. Those who have received monoclonal antibody therapy within half a year; 4. Patients with central nervous system involvement lymphoma; 5. Patients who meet any of the following conditionsHIV positive, HCV antibody positive with HCV RNA positive, HBsAg positive or HBcAb positive with HBV DNA replication level > 10^3; 6. Pregnant and lactating women; 7. Other serious and uncontrollable concomitant diseases that may affect compliance in the trail or affect the explanation of results, including active opportunistic infections or progressive (severe) infections, uncontrolled diabetes disease, cardiovascular disease (grade III or IV heart failure defined by the New York Heart Association classification, above II degree cardiac conduction block, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina pectoris, cerebral infarction within 3 months, etc.) or pulmonary disease (interstitial pneumonia, obstructive pulmonary disease and history of symptomatic bronchospasm); 8. Patients who were considered unsuitable for the study; 9. Suffering or having suffered from any other malignant tumor within 5 years; 10. Chronic or currently active infectious diseases requiring systemic antibiotics, antifungal drugs or antiviral treatment; 11. Women with positive blood / urine pregnancy test at the time of screening or who are breast feeding; 12. Women of child bearing potential or male study participants of reproductive potential refuse to use birth control method of contraception from enrolled the study to 1 year after completing study treatment.; 13. Patients with allergy to rituximab which was defined as transfusion reaction or allergic reaction still occurred during the second infusion of rituximab.

Design outcomes

Primary

MeasureTime frame
ORR;

Countries

China

Contacts

Public ContactJun Zhu
zhujun3346@163.com+86 13910333346

Outcome results

None listed

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