Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified July 2009 by National Cancer Institute (NCI)
Sponsor:
German High-Grade Non-Hodgkin's Lymphoma Study Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278408
First received: January 16, 2006
Last updated: April 16, 2010
Last verified: July 2009
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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 |
Biological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| 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] |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Prednisone
Vincristine sulfate
Doxorubicin
Doxorubicin hydrochloride
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Rituximab
U.S. FDA Resources
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
Show 79 Study LocationsSponsors and Collaborators
German High-Grade Non-Hodgkin's Lymphoma Study Group
Investigators
| Study Chair: | Michael G.M. Pfreundschuh, MD | Universitaetsklinikum des Saarlandes |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00278408 History of Changes |
| Other Study ID Numbers: | CDR0000459796, DSHNHL-2004-3, EUDRACT-2005-005218-19, EU-205111 |
| Study First Received: | January 16, 2006 |
| Last Updated: | April 16, 2010 |
| 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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large-Cell, Immunoblastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Doxorubicin Prednisone Vincristine |
Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on May 22, 2013