Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma - Full Text View

Sponsored by:	German High-Grade Non-Hodgkin's Lymphoma Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00278408

Purpose

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving rituximab and combination chemotherapy together with radiation therapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy with or without radiation therapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: filgrastim Drug: prednisone Drug: rituximab Drug: vincristine sulfate Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Filgrastim Prednisone Vincristine sulfate Vincristine Rituximab Tositumomab Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label
Official Title:	Randomized Study Comparing an Immuno-Chemotherapy With 6 Cycles of the Monoclonal Anti-CD20 Antibody Rituximab in Combination With 6 Cycles of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) at 21-Day Intervals or 14-Day Intervals, Both With or Without Consolidating Radiotherapy or Large Tumour Masses (≥7.5 cm) and/or Extranodal Involvement in Patients With Aggressive CD20 B-Cell Lymphoma Aged 18 to 60 Years With Age-Adjusted IPI=1 (All) or IPI=0 With a Large Tumour Mass (≥7.5 cm) [UNFOLDER 21/14 Study]

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to treatment failure (TTF) measured from day 1 of course 1 of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy up to 3 years on study with life-long follow-up [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete response (CR) rate until first relapse [ Designated as safety issue: No ]
Progression rate during treatment [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]
Tumor control measured from day 1 of course 1 of CHOP therapy (non-tumor related events are censored) [ Designated as safety issue: No ]
Disease-free survival measured from day 1 of course 1 of CHOP therapy [ Designated as safety issue: No ]
Relapse-free survival of patients with complete response (CR) or unconfirmed complete response (CRu) following complete immunochemotherapy [ Designated as safety issue: No ]
Safety (adverse events, serious adverse events) assessed at 3 months after completion of study treatment [ Designated as safety issue: Yes ]
Consolidating radiotherapy [ Designated as safety issue: No ]

Estimated Enrollment:	1072
Study Start Date:	November 2005
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:
- Grade 3 follicular lymphoma
- Diffuse B-cell lymphoma, including diffuse large cell lymphoma with the following variants:
  - Centroblastic
  - Immunoblastic
  - Plasmablastic
  - Anaplastic large cell
  - T-cell-rich B-cell lymphoma
- Primary effusion lymphoma
- Intravascular B-cell lymphoma
- Primary mediastinal B-cell lymphoma
- Burkitt's or Burkitt-like lymphoma
- Mantle cell lymphoma (blastoid)
- Aggressive marginal zone lymphoma (monocytoid)
Previously untreated disease
CD20-positive disease
International prognostic index (IPI) score 0 or 1 (age-adjusted)
- Only patients with bulky disease, as defined by largest single or conglomerate tumor ≥ 7.5 cm in diameter, are allowed to have an IPI score of 0
No mucosa-associated lymphoid tissue (MALT) lymphoma
No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Platelet count ≥ 100,000/mm³
WBC ≥ 2,500/mm³
No known hypersensitivity to the study medications
No known HIV-positivity
No active hepatitis infection
Not pregnant or lactating
Negative pregnancy test
No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer
No impaired left ventricular function
No severe cardiac arrhythmias
No other impaired organ function
No other serious disorder

PRIOR CONCURRENT THERAPY:

No prior chemotherapy or radiotherapy
No prior immunosuppressive treatment with cytostatics
No concurrent participation in other treatment studies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278408

Show 79 Study Locations

Sponsors and Collaborators

German High-Grade Non-Hodgkin's Lymphoma Study Group

Investigators

Study Chair:

Michael G.M. Pfreundschuh, MD

Universitaetsklinikum des Saarlandes

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000459796, DSHNHL-2004-3, EUDRACT-2005-005218-19, EU-205111
Study First Received:	January 16, 2006
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00278408
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
stage I grade 3 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 3 follicular lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma

nodal marginal zone B-cell lymphoma
anaplastic large cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
contiguous stage II adult Burkitt lymphoma
contiguous stage II mantle cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II mantle cell lymphoma
stage I adult Burkitt lymphoma
stage I mantle cell lymphoma
stage III adult Burkitt lymphoma
stage III mantle cell lymphoma

Study placed in the following topic categories:

Prednisone
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Cyclophosphamide
Lymphoma, large-cell, immunoblastic
Lymphoma, B-Cell
Lymphoma, large-cell
Burkitt's lymphoma
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large-Cell, Anaplastic
Aggression
Lymphoma
Immunoglobulins

Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Vincristine
Mantle cell lymphoma
Doxorubicin
Lymphatic Diseases
Antibodies
Burkitt Lymphoma
B-cell lymphomas
Anaplastic large cell lymphoma
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Follicular lymphoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimitotic Agents
Antibiotics, Antineoplastic

Hormones
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009