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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT00690560
First received: June 3, 2008
Last updated: February 8, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Radiation: yttrium Y 90 ibritumomab tiuxetan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: up to one year ] [ Designated as safety issue: No ]
  • Relapse-free survival in responding patients [ Time Frame: up to one year ] [ Designated as safety issue: No ]
  • Rate of disease progression [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: up to six months ] [ Designated as safety issue: No ]
  • Toxicities [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2007
Study Completion Date: October 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R-CHOP14 chemotherapy Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: yttrium Y 90 ibritumomab tiuxetan

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.
  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00690560

Locations
France
Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Study Chair: Frederec Peyrade, MD Centre Antoine Lacassagne
  More Information

Additional Information:
No publications provided

Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT00690560     History of Changes
Other Study ID Numbers: CDR0000589530, CALACASS-3RCHOPZ, INCA-RECF0624, EUDRACT-2006-006179-19, CALACASS-2006/27
Study First Received: June 3, 2008
Last Updated: February 8, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Antoine Lacassagne:
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

Additional relevant MeSH terms:
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Doxorubicin
Liposomal doxorubicin
Rituximab
Vincristine
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on April 26, 2015