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

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 Steroids

Drug Information available for: Cyclophosphamide Prednisone Vincristine sulfate Yttrium Doxorubicin Doxorubicin hydrochloride Rituximab Ibritumomab tiuxetan

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Lymphoma, Large-cell B-cell Lymphoma Diffuse Large B-Cell Lymphoma

U.S. FDA Resources

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 (Adult, Senior)
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


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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Liposomal doxorubicin Doxorubicin Prednisone Vincristine Antibodies, Monoclonal Immunosuppressive Agents	Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents Glucocorticoids Hormones

ClinicalTrials.gov processed this record on September 28, 2016