Description:
This is a prospective single arm, multi-center, phase II clinical trial to observe the
efficacy and safety of R-CHOP (Rituximab-Cyclophosphamide, Epirubicin, Vincristine and
Prednisone) combined with lenalidomide in the first-line treatment for patients with medium
to high risk/high risk diffuse large B cell lymphoma.
Title
- Brief Title: R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma
- Official Title: A Single Arm, Multi-center, Phase II Clinical Trial of R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Medium to High Risk/High Risk Diffuse Large B Cell Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
HNSZLYYNHL02
- NCT ID:
NCT04214626
Conditions
- Diffuse Large B Cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Rituximab | RiTUXimab Injection | R-CHOP regimen Combined With Lenalidomide |
Lenalidomide | Lenalidomide capsule | R-CHOP regimen Combined With Lenalidomide |
Cyclophosphamide | Cyclophosphamide Injection | R-CHOP regimen Combined With Lenalidomide |
Epirubicin | Epirubicin hydrochloride | R-CHOP regimen Combined With Lenalidomide |
Vincristine | Vincristine Injection | R-CHOP regimen Combined With Lenalidomide |
Prednisone | Prednisone Oral Product | R-CHOP regimen Combined With Lenalidomide |
Methotrexate | Methotrexate Injectable Solution | R-CHOP regimen Combined With Lenalidomide |
Purpose
This is a prospective single arm, multi-center, phase II clinical trial to observe the
efficacy and safety of R-CHOP (Rituximab-Cyclophosphamide, Epirubicin, Vincristine and
Prednisone) combined with lenalidomide in the first-line treatment for patients with medium
to high risk/high risk diffuse large B cell lymphoma.
Detailed Description
Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma
(NHL). Currently, R-CHOP is world-widely used in the first-line treatment for DLBCL. There
are about one second of patients suffering relapse and drug resistance. Lenalidomide is an
analog of thalidomide, the mechanism of anti-tumor action has not been fully elucidated.
Lenalidomide has been proved to inhibit the proliferation of tumor cells in certain
hematopoietic systems. At present, it has been approved for the treatment of multiple myeloma
with good efficacy and safety. The goal of our trial is to assess the efficacy and safety of
R-CHOP combined with lenalidomide in the first-line treatment for patients with medium to
high risk/high risk diffuse large B cell lymphoma.
Trial Arms
Name | Type | Description | Interventions |
---|
R-CHOP regimen Combined With Lenalidomide | Experimental | Induction Chemotherapy: Rituximab, 375mg/m2, Intravenous administration on day 0, Lenalidomide, 25mg oral administration on day 1 to 10, combined with regimen:CHOP (Cyclophosphamide, Epirubicin, Vincristine and Prednisone): repeated every 3 weeks, up to 6 cycles.
PS: Methotrexate, 3mg/m2, Intravenous administration on day 3 of each 3-week cycle, from 2 to 5 cycles for patients with high recurrence risk of the central nervous system.
Maintenance Treatment: Rituximab, 375mg/m2, Intravenous administration on day 0 repeated every 4 weeks, up to 2 cycles; Lenalidomide, 10mg oral administration on day 1 to 21 repeated every 4 weeks, up to 12 cycles. | - Rituximab
- Lenalidomide
- Cyclophosphamide
- Epirubicin
- Vincristine
- Prednisone
- Methotrexate
|
Eligibility Criteria
Inclusion Criteria:
1. Age between 18 to 70 years old (including 18 and 70)
2. Diagnosed as diffuse large B cell lymphoma
3. Subjects must be untreated (medium to high risk/high risk: International Prognostic
Index (IPI) score 3-5, aaIPI score 2-3 or NCCN-IPI score≥ 4/ Immunohistochemical
staining of double expression (BCL2 ≥ 70% and C-MYC ≥ 40%) or P53 protein mutation
positive ≥ 50%)
4. No receiving chemotherapy before enrollment
5. Having at least one measurable lesions
6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG)
0-1
7. Life expectancy no less than 3 months
8. enough main organ function
9. Pregnancy test within 7 days must be negative for women of childbearing period, and
appropriate measures should be taken for contraception for women in childbearing
period during the study and six months after this study
10. Agreeing to sign the written informed consents
Exclusion Criteria:
1. Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or
triple-strike
2. Diagnosed as grey-zone lymphoma
3. Diagnosed as central nervous system lymphoma
4. Diagnosed as primary mediastinal large B-cell lymphoma
5. Diagnosed as CD20 negative diffuse large B-cell lymphoma
6. Other malignant tumor history or active malignant tumor need be treated
7. Serious surgery and trauma less than two weeks
8. Systemic therapy for serious acute/chronic infection
9. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart
infarction less than 6 months
10. Vaccination with live attenuated vaccine less than 4 weeks
11. HIV-positive, AIDS patients and untreated active hepatitis
12. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12
months
13. Patients with a history of mental illness
14. Researchers determine unsuited to participate in this trial
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 2-year progression-free survival |
Time Frame: | from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment |
Safety Issue: | |
Description: | the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first |
Secondary Outcome Measures
Measure: | objective response rate |
Time Frame: | every 6 weeks from the day of the first cycle of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment |
Safety Issue: | |
Description: | the total proportion of patients with complete response (CR) and partial response (PR) |
Measure: | 2-year overall survival |
Time Frame: | from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years |
Safety Issue: | |
Description: | from date of first day of treatment to the date of death by any cause |
Measure: | incidence and relationship with study drugs of grade 3-4 adverse events |
Time Frame: | from the date of the first cycle of treatment to 18 months after last patient's enrollment |
Safety Issue: | |
Description: | the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03) |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Henan Cancer Hospital |
Trial Keywords
- Diffuse Large B Cell Lymphoma
- R-CHOP
- Lenalidomide
Last Updated
August 17, 2021