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

September 21, 2011 updated by: Deok-Hwan Yang, Chonnam National University Hospital

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Jeollanam-do, Korea, Republic of, 519-809
        • Recruiting
        • Chonnam National University Hwasun Hosptial
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three years after the completion of rituximab augmentation
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).
three years

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: Three years after the completion of rituximab augmentation
Three years after the completion of rituximab augmentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Collaborators

Samsung Medical Center
Asan Medical Center
Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

August 11, 2010

First Submitted That Met QC Criteria

August 13, 2010

First Posted (Estimate)

August 16, 2010

Study Record Updates

Last Update Posted (Estimate)

September 22, 2011

Last Update Submitted That Met QC Criteria

September 21, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25393

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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