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

Primary Purpose

Lymphoma, Large B-cell, Diffuse

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
rituximab
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large B-cell, Diffuse focused on measuring diffuse large B-cell lymphoma, elderly patients, rituximab augmentation

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hwasun HosptialRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rituximab

Arm Description

Outcomes

Primary Outcome Measures

the overall response rate
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
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

Full Information

First Posted
August 11, 2010
Last Updated
September 21, 2011
Sponsor
Chonnam National University Hospital
Collaborators
Samsung Medical Center, Asan Medical Center, Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01181999
Brief Title
Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
Collaborators
Samsung Medical Center, Asan Medical Center, Severance Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-cell, Diffuse
Keywords
diffuse large B-cell lymphoma, elderly patients, rituximab augmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rituximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
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 Measure Information:
Title
the overall response rate
Description
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.
Time Frame
three years after the completion of rituximab augmentation
Title
Number of patients with adverse events
Description
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).
Time Frame
three years
Secondary Outcome Measure Information:
Title
progression-free survival
Time Frame
Three years after the completion of rituximab augmentation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed CD20 positive DLBCL Age ≥ 70 Ann Arbor stage II, III and IV No prior chemotherapy or radiotherapy for DLBCL Performance status (Eastern Cooperative Oncology Group) ≤ 2 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 Cardiac ejection fraction ≥ 50% as measured by echocardiogram without clinically significant abnormalities Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L) Adequate liver functions: 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 Life expectancy more than 6 months Informed consent Exclusion Criteria: Other subtypes of non-Hodgkin's lymphoma Patients who transformed follicular lymphoma or other indolent lymphoma Primary Central Nervous System (CNS) DLBCL CNS involvement by lymphoma or any evidence of spinal cord compression. Patients with a known history of human immunodeficiency virus (HIV) seropositivity or hepatitis C virus (+). Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri Pregnant or lactating women, women of childbearing potential not employing adequate contraception Other serious illness or medical conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deok-Hwan Yang, M.D. and Ph.D.
Phone
82-61-379-7636
Email
drydh1685@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Je-Jung Lee, M.D. and Ph.D.
Phone
82-61-3797638
Email
drjejung@chonnam.ac.kr
Facility Information:
Facility Name
Chonnam National University Hwasun Hosptial
City
Jeollanam-do
ZIP/Postal Code
519-809
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deok-Hwan Yang, M.D. and Ph.D.
Phone
82-61-3797636
Email
drydh1685@gmail.com
First Name & Middle Initial & Last Name & Degree
So-Young Lee, Nurse
Phone
82-61-3768090
Email
kaosin@naver.com

12. IPD Sharing Statement

Learn more about this trial

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

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