Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
NCT ID: NCT00003815
Last Updated: 2013-09-17
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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UNKNOWN
PHASE3
INTERVENTIONAL
1994-06-30
Brief Summary
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PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow transplantation in treating patients who have aggressive non-Hodgkin's lymphoma.
Detailed Description
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* Assess the rate of remission in patients with aggressive non-Hodgkin's lymphoma treated with high-dose chemotherapy and radiotherapy plus autologous bone marrow transplantation.
* Determine the efficacy and toxic effects of this regimen in these patients.
OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to risk group (good vs intermediate vs poor).
Patients undergo harvest of autologous bone marrow stem cells after priming chemotherapy and before transplantation.
Patients receive induction chemotherapy comprising the CHOP or VAPEC-B regimen. The CHOP regimen consists of vincristine (VCR) IV, cyclophosphamide (CTX) IV, and doxorubicin (DOX) IV on day 1 and oral prednisolone (PRDL) on days 1-5. Treatment repeats every 3 weeks for six courses. The VAPEC-B regimen consists of DOX IV on days 1, 15, 29, 43, 57, and 71; CTX IV on days 1, 29, and 57; VCR IV on days 8, 22, 36, 50, and 64; bleomycin IV on days 8, 36, 64; oral etoposide (VP-16) on days 15-19, 43-47, and 71-75; and oral PRDL daily for 13 weeks.
Patients then may undergo radiotherapy for 2-3 weeks to areas of original bulk or residual disease.
* Good-risk group: Patients are randomized to one of two treatment arms.
* Arm I: Patients receive no further treatment.
* Arm II: Patients receive melphalan (L-PAM) before or after total body irradiation (TBI), which is delivered in 3 fractions over 24 hours. After completion of radiotherapy, patients undergo autologous bone marrow transplantation (AuBMT).
* Intermediate- or poor-risk group: Patients are randomized one of three treatment arms.
* Arm III: Patients receive L-PAM IV on day -2 and AuBMT on day 0.
* Arm IV: Patients receive treatment as in arm II.
* Arm V: Patients receive carmustine IV on day -6, VP-16 IV once daily and cytarabine IV twice daily on days -5 to -2, and L-PAM IV on day -1. Radiotherapy to bulk disease begins after completion of chemotherapy. Patients undergo AuBMT on day 0.
Patients are followed monthly for 3 months, every 2 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: Not specified
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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bleomycin sulfate
carmustine
cyclophosphamide
cytarabine
doxorubicin hydrochloride
etoposide
melphalan
prednisolone
vincristine sulfate
autologous bone marrow transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed aggressive non-Hodgkin's lymphoma requiring chemotherapy
* Stage II, III, or IV
* B cell:
* Centroblastic
* Immunoblastic
* Large cell anaplastic
* Non-Burkitt lymphoblastic
* T cell:
* Pleomorphic medium cell
* Pleomorphic large cell
* Immunoblastic
* Large cell anaplastic
* Lymphoblastic
* No Burkitt (L3) subtype
* No large mediastinal mass OR
* Stage I, II, III, or IV
* Bulk disease greater than 10 cm
* Nodal or extranodal site
* No primary localized gut lymphoma
* No CNS involvement
PATIENT CHARACTERISTICS:
Age:
* 15 to 65
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* No concurrent bone marrow dysplastic syndromes
Hepatic:
* Bilirubin no greater than 2.5 times upper limit of normal (ULN)
Renal:
* Creatinine no greater than 2.5 times ULN
Other:
* No other malignancy except skin cancer or stage I cervical cancer
* Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
15 Years
65 Years
ALL
No
Sponsors
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Scotland and Newcastle Lymphoma Group
OTHER
Principal Investigators
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Stephen J. Proctor, MD, FRCP, FRCPath
Role: STUDY_CHAIR
Newcastle-upon-Tyne Hospitals NHS Trust
Locations
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Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, United Kingdom
Countries
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Other Identifiers
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SNLG-NHL-Va
Identifier Type: -
Identifier Source: secondary_id
EU-98032
Identifier Type: -
Identifier Source: secondary_id
CDR0000066967
Identifier Type: -
Identifier Source: org_study_id