Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma
NCT ID: NCT00079261
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2004-01-31
Brief Summary
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PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.
Detailed Description
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Primary
* Compare the complete response rate (confirmed or unconfirmed) in patients with previously untreated aggressive non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone with vs without gemcitabine.
Secondary
* Compare the safety profile of these regimens in these patients.
* Compare the feasibility of these regimens, defined as the proportion of courses given as scheduled, in these patients.
* Compare freedom from treatment failure in patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, International Prognostic Index score (0-2 vs 3-5), and histology (B cell vs T cell). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral or IV prednisone on days 1-5.
* Arm II: Patients receive CHOP chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.
In both arms, treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity or progressive disease. Patients achieving partial response or complete or unconfirmed complete response receive an additional 5 courses of therapy (for a total of 8 courses).
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 76-82 patients (38-41 per treatment arm) will be accrued for this study within 2 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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CHOP regimen
cyclophosphamide
doxorubicin hydrochloride
gemcitabine hydrochloride
prednisone
vincristine sulfate
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes:
* Diffuse large B large cell lymphoma (including all clinical and morphologic variants)
* Grade 3 follicular lymphoma
* Extranodal T/NK cell lymphoma, nasal type
* Enteropathy-type T cell lymphoma
* Hepato-splenic T cell lymphoma
* Peripheral T cell lymphoma, unspecified
* Angioimmunoblastic lymphoma
* Anaplastic large cell lymphoma, systemic type
* Stage II-IV disease
* At least 1 site of measurable disease (e.g., lymph node or lymph node mass)
* The following subtypes are not allowed:
* Mantle cell lymphoma
* Burkitt's lymphoma
* Precursor B or T cell lymphoma
* Primary cutaneous B or T cell lymphoma
* No CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
Age
* 18 to 70
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* WBC \> 3,000/mm\^3
* Neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
Hepatic
* Bilirubin \< 2.5 times normal (unless due to lymphoma)
* ALT and AST \< 2.5 times normal (unless due to lymphoma)
Renal
* Creatinine \< 2.0 mg/dL
Cardiovascular
* No severe cardiac disease that would preclude study participation or limit life expectancy
Pulmonary
* FEV\_1 and DLCO ≥ 75% of predicted (unless due to lymphoma)
* No severe pulmonary disease that would preclude study participation or limit life expectancy
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No severe neurologic or metabolic disease that would preclude study participation or limit life expectancy
* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent monoclonal antibodies
Chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* No prior cytotoxic agents
* No prior treatment for NHL
* No other concurrent anticancer therapy
* No other concurrent investigational drugs
18 Years
70 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Igor Aurer, MD, PhD
Role: STUDY_CHAIR
University Hospital Rebro
Locations
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U.Z. Gasthuisberg
Leuven, , Belgium
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, , Belgium
University Hospital Rebro
Zagreb, , Croatia
National Cancer Institute - Cairo
Cairo, , Egypt
Institut Bergonie
Bordeaux, , France
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, , Netherlands
Countries
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References
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Aurer I, Eghbali H, Raemaekers J, Khaled HM, Fortpied C, Baila L, van der Maazen RW; EORTC Lymphoma Group. Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin's lymphoma--EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54). Eur J Haematol. 2011 Feb;86(2):111-6. doi: 10.1111/j.1600-0609.2010.01540.x. Epub 2010 Dec 22.
Other Identifiers
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EORTC-20021
Identifier Type: -
Identifier Source: secondary_id
EORTC-20021
Identifier Type: -
Identifier Source: org_study_id