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Study of Pomalidomide as Maintenance Therapy to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Non-Hodgkin's Lymphoma

Study of Pomalidomide as Maintenance Therapy to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Non-Hodgkin's Lymphoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046983
Enrollment
Unknown
Registered
2021-06-06
Start date
2021-06-04
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

B cell non-Hodgkin lymphoma

Interventions

Group1:1mg dosage
Group2:2mg dosage
Group3:4mg dosage

Sponsors

Xinqiao Hospital Affiliated to Army Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with B-cell non-Hodgkin's lymphoma diagnosed by histopathology of age >=18 years; 2. Achieve the curative effect of PR and above after front-line treatment; 3. ECOG-PS 0-2; 4. Bone marrow hematopoietic function is basically normal blood routine: white blood cell count> 3000/uL, absolute neutrophil count >=1.5 x 10^9/L (granulocyte colony stimulating factor is allowed), platelet count >= 75x10^9/L (allowing blood transfusion to reach The minimum platelet count), hemoglobin >=9.0g/dL (pre-infusion of red blood cells or the use of recombinant human erythropoietin is allowed). If lymphoma invades the bone marrow or spleen and causes abnormal peripheral blood indicators, the investigator can judge whether it is suitablefor inclusion; 5. The main organ function is normal: liver function: serum bilirubin= 6 months; 7. The patient was fully informed and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who are known to have a history of severe allergies to pomalidomide or immunomodulatory drugs or those who have any contraindications; 2. Heart diseases with clinical significance include acute myocardial infarction, congestive heart failure (NYHA) grade III or IV in the 6 months before screening for unstable angina pectoris; 3. Subjects with acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons; 4. Women during pregnancy or lactation; 5. Systemic treatment of active bacterial, fungal and/or viral infections that cannot be controlled; 6. Have a history of serious neurological or psychiatric diseases, including dementia or epilepsy; 7. Concomitant with other malignant tumors within the last 5 years or at the same time, excluding cured skin basal cell carcinoma or cervical carcinoma in situ, or early prostate cancer that does not require systemic treatment, or only requires surgery to treat early breast cancer; 8. Drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in research or evaluation of research results; 9. Patients considered by the investigator to be unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Duration of relief;Overall survival;Safety;

Countries

China

Contacts

Public ContactXiang Qianqian, Gao Li

Xinqiao Hospital Affiliated to Army Military Medical University

cherry_xiangxixi@163.com+86 15310334388

Outcome results

None listed

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