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:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01054781
First received: January 20, 2010
Last updated: September 26, 2012
Last verified: September 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 20, 2010
Last Updated: September 26, 2012
Health Authority: Korea: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 19, 2014