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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2010 by Chonnam National University Hospital
Sponsor:
Collaborators:
Samsung Medical Center
Asan Medical Center
Severance Hospital
Information provided by (Responsible Party):
Deok-Hwan Yang, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01181999
First received: August 11, 2010
Last updated: September 21, 2011
Last verified: July 2010
  Purpose

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 Intervention Phase
Lymphoma, Large B-cell, Diffuse
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: 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)

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • the overall response rate [ Time Frame: three years after the completion of rituximab augmentation ] [ Designated as safety issue: Yes ]
    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.

  • Number of patients with adverse events [ Time Frame: three years ] [ Designated as safety issue: Yes ]
    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:
  • progression-free survival [ Time Frame: Three years after the completion of rituximab augmentation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: August 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Deok-Hwan Yang, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01181999     History of Changes
Other Study ID Numbers: ML25393
Study First Received: August 11, 2010
Last Updated: September 21, 2011
Health Authority: Korea:Korean Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on August 20, 2014