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Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT01181999
Recruitment Status : Unknown
Verified July 2010 by Deok-Hwan Yang, Chonnam National University Hospital.
Recruitment status was:  Recruiting
First Posted : August 16, 2010
Last Update Posted : September 22, 2011
Sponsor:
Collaborators:
Samsung Medical Center
Asan Medical Center
Severance Hospital
Information provided by (Responsible Party):
Deok-Hwan Yang, Chonnam National University Hospital

Brief Summary:

Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL).

The study is aimed to evaluate the overall response rate and the safety of four cycles of R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in newly diagnosed DLBCL patients with aged more than 70 years.


Condition or disease Intervention/treatment Phase
Lymphoma, Large B-cell, Diffuse Drug: rituximab Phase 2

Detailed Description:
  1. Four cycles of R-CHOP chemotherapy for the induction treatment [Dose intensity of CHOP chemotherapy is modulated according to Charlson Comorbidity Index (CCI)]

    If patients with CCI <1

    • Rituximab: 375 mg/m2, day 1 every 3 weeks.
    • Conventional dose of CHOP chemotherapy repeat every 3 weeks.

    If patients with CCI ≥1

    • Rituximab: 375 mg/m2, day 1 every 3 weeks.
    • 75% of conventional CHOP repeat every 3 weeks.
  2. Rituximab augmentation

    • Rituximab: 375 mg/m2, every week x 4 times.
    • Trimethoprim-sulfamethoxazole 1 tablet per day during augmentation

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Rituximab (R) Augmentation Following R-CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone) Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma (DLBCL)
Study Start Date : August 2010
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: rituximab Drug: rituximab
A dose of 375mg/m2 rituximab will be administered intravenously on day 1 of first to fourth R-CHOP chemotherapy and on day 1, 8, 15, 22 of each augmentation chemotherapy.



Primary Outcome Measures :
  1. the overall response rate [ Time Frame: three years after the completion of rituximab augmentation ]
    To evaluate the objective overall response rate of four cycles of R-CHOP and followed by four times weekly rituximab augmentation in exteremely elderly patients with DLBCL.

  2. Number of patients with adverse events [ Time Frame: three years ]
    All patients will be evaluated for the toxicity during the treatment. Toxicity is graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC v3.0).


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: Three years after the completion of rituximab augmentation ]


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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed CD20 positive DLBCL
  2. Age ≥ 70
  3. Ann Arbor stage II, III and IV
  4. No prior chemotherapy or radiotherapy for DLBCL
  5. Performance status (Eastern Cooperative Oncology Group) ≤ 2
  6. At least one or more bidimensionally measurable lesion(s)

    • ≥ 2 cm by conventional computerized tomography (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 echocardiogram without clinically significant abnormalities
  8. Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L)
  9. Adequate liver functions:
  10. Adequate bone marrow functions:

    hemoglobin ≥ 9 g/dL absolute neutrophil count ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma

  11. Life expectancy more than 6 months
  12. Informed consent

Exclusion Criteria:

  1. Other subtypes of non-Hodgkin's lymphoma
  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.
  5. Patients with a known history of human immunodeficiency virus (HIV) seropositivity or hepatitis C virus (+).
  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

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): NCT01181999


Contacts
Contact: Deok-Hwan Yang, M.D. and Ph.D. 82-61-379-7636 drydh1685@gmail.com
Contact: Je-Jung Lee, M.D. and Ph.D. 82-61-3797638 drjejung@chonnam.ac.kr

Locations
Korea, Republic of
Chonnam National University Hwasun Hosptial Recruiting
Jeollanam-do, Korea, Republic of, 519-809
Contact: Deok-Hwan Yang, M.D. and Ph.D.    82-61-3797636    drydh1685@gmail.com   
Contact: So-Young Lee, Nurse    82-61-3768090    kaosin@naver.com   
Sponsors and Collaborators
Chonnam National University Hospital
Samsung Medical Center
Asan Medical Center
Severance Hospital

Responsible Party: Deok-Hwan Yang, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01181999     History of Changes
Other Study ID Numbers: ML25393
First Posted: August 16, 2010    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: July 2010

Keywords provided by Deok-Hwan Yang, Chonnam National University Hospital:
diffuse large B-cell lymphoma
elderly patients
rituximab augmentation

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