Follicular Lymphoma Clinical Trial
Official title:
R2 in the Treatment of Follicular Lymphoma Grade 1-3A
| Verified date | July 2019 |
| Source | Ruijin Hospital |
| Contact | Weili Zhao |
| Phone | +86 64370045 |
| Zhao.weili[@]yahoo.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Lenalidomide Based Immunotherapy in the Treatment of FL
| Status | Recruiting |
| Enrollment | 115 |
| Est. completion date | November 1, 2020 |
| Est. primary completion date | November 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 75 Years |
| Eligibility |
Inclusion Criteria: Patients diagnose as de novo or relapse refractory FL grade 1-3A . No history of stem cell transplantation. Written informed consent. Exclusion Criteria: Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study. Clinically significant active infection. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures. Subject has =grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment. Patients who are pregnant or breast-feeding. HIV infection. |
| Country | Name | City | State |
|---|---|---|---|
| China | Ruijin Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Ruijin Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CR | Complete response rate | 12 weeks | |
| Secondary | PFS | Progression free survival rate | 1 year | |
| Secondary | OS | Overall survival rate | 1 year | |
| Secondary | ORR | Overall response rate | 12 weeks |
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