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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:
Centre Antoine Lacassagne
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
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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:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Ibritumomab tiuxetan
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
B-cell Lymphoma
Diffuse Large B-Cell Lymphoma
Lymphoma, Large-cell
U.S. FDA Resources
Further study details as provided by Centre Antoine Lacassagne:
Primary Outcome Measures:
- Event-free survival [ Time Frame: 1 year ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: up to one year ]
- Relapse-free survival in responding patients [ Time Frame: up to one year ]
- Rate of disease progression [ Time Frame: up to 2 years ]
- Response rate [ Time Frame: up to six months ]
- Toxicities [ Time Frame: up to 2 years ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00690560
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
| 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 |
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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Doxorubicin Liposomal doxorubicin Prednisone Cyclophosphamide Rituximab Vincristine Antibodies, Monoclonal Antibiotics, Antineoplastic |
Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on June 23, 2017