Intensified 1st Cycle Rituximab Plus 8th Cycles of R-CHOP Chemotherapy in Patients With Advanced or Bulky CD20+ Diffuse Large B-cell Lymphoma (DLBCL)
Open-labelled, Multicenter Phase II Study of Intensified 1st Cycle Rituximab Plus 8th Cycles of R-CHOP Chemotherapy in Patients With Advanced or Bulky CD20+ Diffuse Large B-cell Lymphoma (DLBCL)
1 other identifier
interventional
91
1 country
1
Brief Summary
The purpose of this study is to evaluate the complete response (CR) rate after Intensified 1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 20, 2010
CompletedFirst Posted
Study publicly available on registry
January 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedSeptember 27, 2012
September 1, 2012
1.8 years
January 20, 2010
September 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the complete response (CR) rate after Intensified 1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL and
12 months
Secondary Outcomes (6)
To evaluate the overall response rate of R+R-CHOP
12 months
To evaluate the duration of overall response
12 months
To evaluate the safety and tolerability of the R+R-CHOP combination treatment.
12 months
To evaluate the progression free survival.
12 months
To estimate the overall survival.
12 months
- +1 more secondary outcomes
Interventions
1st cycle R+R-CHOP 2-8th cycle R-CHOP
Eligibility Criteria
You may qualify if:
- Histologically confirmed CD20 positive Diffuse Large B-cell Lymphoma (DLBCL)
- Advanced stage: stage III, IV and/or bulky disease (largest diameter ≥ 10.0 cm) regardless of stage
- Previously untreated.
- Performance status: ECOG 0-2.
- Age ≥ 18
- At least one or more bidimensionally measurable lesion(s)
- ≥ 2 cm by conventional CT
- ≥ 1 cm by spiral CT
- skin lesion (photographs should be taken) ≥ 2 cm
- measurable lesion by physical examination ≥ 2 cm
- Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormalities
- Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L)
- Adequate liver functions:
- Transaminase (AST/ALT) \< 3 X upper normal value (or \< 5 x ULN in the presence of DLBCL involvement of the liver)
- Bilirubin \< 2 X upper normal value (or \< 5 x ULN in the presence of DLBCL involvement of the liver)
- +4 more criteria
You may not qualify if:
- Other subtypes NHL than DLBCL
- Patients who transformed follicular lymphoma or other indolent lymphoma
- Primary Central Nervous System (CNS) DLBCL;
- CNS involvement by lymphoma or any evidence of spinal cord compression. Brain CT/MRI is only mandatory (within 4 weeks) in case of clinical suspicion of CNS involvement by lymphoma. Patients who have only had prophylactic intrathecal chemotherapy against CNS disease are eligible.
- Patients with a known history of HIV seropositivity or HCV (+). Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
- Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- History of significant neurological or psychiatric disorders including dementia or seizures
- Active uncontrolled infection (viral, bacterial or fungal infection)
- Other serious medical illnesses
- Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
Related Publications (1)
Kim YR, Kim JS, Kim WS, Eom HS, Yang DH, Bae SH, Kim HJ, Lee JH, Oh SJ, Yoon SS, Kwak JY, Choi CW, Kim MK, Oh SY, Kang HJ, Nam SH, Shim H, Park JS, Mun YC, Suh C; Korean Society of Hematology Lymphoma Working Party. Intensified First Cycle of Rituximab Plus Eight Cycles of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone with Rituximab Chemotherapy for Advanced-Stage or Bulky Diffuse Large B-Cell Lymphoma: A Multicenter Phase II Consortium for Improving Survival of Lymphoma (CISL) Study. Cancer Res Treat. 2023 Oct;55(4):1355-1362. doi: 10.4143/crt.2023.271. Epub 2023 Mar 30.
PMID: 36996864DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
WonSeog Kim, M.D., PhD.
Samsung Medical Center, Seoul, Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 20, 2010
First Posted
January 22, 2010
Study Start
January 1, 2009
Primary Completion
November 1, 2010
Last Updated
September 27, 2012
Record last verified: 2012-09