search
Back to results

Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
yttrium Y 90 ibritumomab tiuxetan
Sponsored by
Centre Antoine Lacassagne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed large B-cell lymphoma

    • Stage I, II, III, or IV disease
    • Bone marrow or lymph node involvement by small cell lymphoma allowed
    • No serious, progressive pathology (at investigator's discretion)
  • CD20-positive disease
  • Measurable disease
  • No prior indolent lymphoma, treated or not
  • No meningeal or CNS lymphoma

PATIENT CHARACTERISTICS:

  • International prognostic index < 2 (adjusted for age)
  • Life expectancy > 3 months
  • ALT and AST ≤ 2.5 times upper limit of normal
  • Bilirubin ≤ 30 mmol/L
  • Creatinine ≤ 150 μmol/L
  • HIV, hepatitis B virus, and hepatitis C virus negative (unless after vaccine)
  • No contraindication to chemotherapy or immunotherapy
  • No cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No contraindication to a venous catheter

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 30 days since prior and no other concurrent investigational treatment
  • No prior therapy
  • No concurrent participation in another clinical study

Sites / Locations

  • Centre Antoine Lacassagne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-CHOP14 chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Event-free survival

Secondary Outcome Measures

Overall survival
Relapse-free survival in responding patients
Rate of disease progression
Response rate
Toxicities

Full Information

First Posted
June 3, 2008
Last Updated
February 8, 2015
Sponsor
Centre Antoine Lacassagne
search

1. Study Identification

Unique Protocol Identification Number
NCT00690560
Brief Title
Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma
Official Title
International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may be effective in treating cancer and blocking the body's immune response. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving doxorubicin together with vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell lymphoma.
Detailed Description
OBJECTIVES: Primary Determine event-free survival of patients with large B-cell lymphoma treated with CHOP-R followed by consolidation therapy. Secondary Determine overall survival. Evaluate relapse-free survival for patients achieving complete or partial response. Determine the rate of disease progression. Determine response rate at the end of study therapy. Assess the toxicities of this regimen. OUTLINE: This is a multicenter study. Induction therapy: Patients receive the CHOP-R regimen comprising doxorubicin hydrochloride IV, vincristine IV, cyclophosphamide IV, and rituximab IV on day 1 and prednisone IV on days 1-5. Treatment repeats every 2 weeks for 2 courses. Patients who achieve complete or partial response, as assessed by PET/CT scan, receive a third course of induction therapy. Consolidation therapy: Patients receive rituximab IV on days -8 to 0 and yttrium Y 90 ibritumomab tiuxetan IV on day 0.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-CHOP14 chemotherapy
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 ibritumomab tiuxetan
Primary Outcome Measure Information:
Title
Event-free survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
up to one year
Title
Relapse-free survival in responding patients
Time Frame
up to one year
Title
Rate of disease progression
Time Frame
up to 2 years
Title
Response rate
Time Frame
up to six months
Title
Toxicities
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed large B-cell lymphoma Stage I, II, III, or IV disease Bone marrow or lymph node involvement by small cell lymphoma allowed No serious, progressive pathology (at investigator's discretion) CD20-positive disease Measurable disease No prior indolent lymphoma, treated or not No meningeal or CNS lymphoma PATIENT CHARACTERISTICS: International prognostic index < 2 (adjusted for age) Life expectancy > 3 months ALT and AST ≤ 2.5 times upper limit of normal Bilirubin ≤ 30 mmol/L Creatinine ≤ 150 μmol/L HIV, hepatitis B virus, and hepatitis C virus negative (unless after vaccine) No contraindication to chemotherapy or immunotherapy No cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No contraindication to a venous catheter PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 30 days since prior and no other concurrent investigational treatment No prior therapy No concurrent participation in another clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederec Peyrade, MD
Organizational Affiliation
Centre Antoine Lacassagne
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma

We'll reach out to this number within 24 hrs