Intensified 1st Cycle Rituximab Plus 8th Cycles of R-CHOP Chemotherapy in Patients With Advanced or Bulky CD20+ Diffuse Large B-cell Lymphoma (DLBCL)
NCT ID: NCT01054781
Last Updated: 2012-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Rituximab
1st cycle R+R-CHOP 2-8th cycle R-CHOP
Eligibility Criteria
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Inclusion Criteria
2. Advanced stage: stage III, IV and/or bulky disease (largest diameter ≥ 10.0 cm) regardless of stage
3. Previously untreated.
4. Performance status: ECOG 0-2.
5. Age ≥ 18
6. 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
7. Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormalities
8. Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L)
9. 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)
10. Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
11. Life expectancy ≥ 6 months
12. A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are \< 1 years after the onset of menopause.
13. Informed consent
Exclusion Criteria
2. Patients who transformed follicular lymphoma or other indolent lymphoma
3. Primary Central Nervous System (CNS) DLBCL;
4. 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.
5. 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.
6. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
7. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
8. 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
9. Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
10. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Samsung Medical Center,Division of Hematology-Oncology
Principal Investigators
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WonSeog Kim, M.D., PhD.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center, Seoul, Korea
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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2008-12-005
Identifier Type: -
Identifier Source: org_study_id