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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	May 2007
Actual Primary Completion Date :	March 2010
Actual Study Completion Date :	October 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: R-CHOP14 chemotherapy	Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: yttrium Y 90 ibritumomab tiuxetan

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Event-free survival [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. Overall survival [ Time Frame: up to one year ]
2. Relapse-free survival in responding patients [ Time Frame: up to one year ]
3. Rate of disease progression [ Time Frame: up to 2 years ]
4. Response rate [ Time Frame: up to six months ]
5. Toxicities [ Time Frame: up to 2 years ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	June 4, 2008
Last Update Posted:	February 10, 2015
Last Verified:	February 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; 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