NCT01181999

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 22, 2011

Status Verified

July 1, 2010

Enrollment Period

1.6 years

First QC Date

August 11, 2010

Last Update Submit

September 21, 2011

Conditions

Lymphoma, Large B-cell, Diffuse

Keywords

diffuse large B-cell lymphomaelderly patientsrituximab augmentation

Outcome Measures

Primary Outcomes (2)

  • 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.

    three years after the completion of rituximab augmentation

  • 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).

    three years

Secondary Outcomes (1)

  • progression-free survival

    Three years after the completion of rituximab augmentation

Study Arms (1)

rituximab

EXPERIMENTAL
Drug: rituximab

Interventions

rituximabDRUG

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.

rituximab

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hwasun Hosptial

Jeollanam-do, 519-809, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Deok-Hwan Yang, M.D. and Ph.D.

CONTACT

82-61-379-7636drydh1685@gmail.com

Je-Jung Lee, M.D. and Ph.D.

CONTACT

82-61-3797638drjejung@chonnam.ac.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 16, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2012

Study Completion

September 1, 2014

Last Updated

September 22, 2011

Record last verified: 2010-07

Locations

KR(1)