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Intensified 1st Cycle Rituximab Plus 8th Cycles of R-CHOP Chemotherapy in Patients With Advanced or Bulky CD20+ Diffuse Large B-cell Lymphoma (DLBCL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01054781
First Posted: January 22, 2010
Last Update Posted: September 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Samsung Medical Center
  Purpose
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

Condition Intervention Phase
Diffuse Large B-cell Lymphoma (DLBCL) Drug: Rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • To evaluate the complete response (CR) rate after Intensified 1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL and [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • To evaluate the overall response rate of R+R-CHOP [ Time Frame: 12 months ]
  • To evaluate the duration of overall response [ Time Frame: 12 months ]
  • To evaluate the safety and tolerability of the R+R-CHOP combination treatment. [ Time Frame: 12 months ]
  • To evaluate the progression free survival. [ Time Frame: 12 months ]
  • To estimate the overall survival. [ Time Frame: 12 months ]
  • To explore prognostic or predictive biomarkers [ Time Frame: 12 months ]

Enrollment: 91
Study Start Date: January 2009
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab
    1st cycle R+R-CHOP 2-8th cycle R-CHOP
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Histologically confirmed CD20 positive Diffuse Large B-cell Lymphoma (DLBCL)
  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

  1. Other subtypes NHL than DLBCL
  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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054781


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: WonSeog Kim, M.D., PhD. Samsung Medical Center, Seoul, Korea
  More Information

Responsible Party: WonSeog Kim , M.D., PhD., Samsung Medical Center,Division of Hematology-Oncology
ClinicalTrials.gov Identifier: NCT01054781     History of Changes
Other Study ID Numbers: 2008-12-005
First Submitted: January 20, 2010
First Posted: January 22, 2010
Last Update Posted: September 27, 2012
Last Verified: September 2012

Keywords provided by Samsung Medical Center:
Diffuse Large B-Cell Lymphoma (DLBCL)
rituximab
CHOP

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents