Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00005867 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: bleomycin sulfate Drug: CHOP regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: vincristine sulfate | Phase 3 |
OBJECTIVES:
- Compare the overall survival, failure free survival, disease specific survival, relapse free survival, and response rate in patients with aggressive non-Hodgkin's lymphoma treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP).
- Compare the early and late toxicities of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1 and vincristine and bleomycin IV on day 8. Treatment continues every 14 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral prednisolone daily on courses 1 and 2 and every other day beginning on course 3 and continuing until the end of treatment.
- Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, then every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 310 patients (155 per arm) will be accrued for this study over 5 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 310 participants |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Official Title: | Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma |
| Study Start Date : | January 1998 |
| Actual Study Completion Date : | August 2007 |
- Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)
- Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years
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| Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive non-Hodgkin's lymphoma of 1 of the following types:
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Working formulation:
- Follicular large cell
- Diffuse mixed cell
- Diffuse large cell
- Diffuse immunoblastic OR
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REAL classification:
- Diffuse large B-cell
- Peripheral T-cell
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- Measurable or evaluable disease
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Good prognosis defined as no more than one of the following:
- Stage III/IV disease
- LDH greater than upper limit of normal
- ECOG/WHO 2-4
- No lymphoblastic or Burkitt's lymphoma
- No CNS involvement
PATIENT CHARACTERISTICS:
Age:
- 18 to 59
Performance status:
- See Disease Characteristics
Life expectancy:
- Not specified
Hematopoietic:
- Hemoglobin at least 10 g/dL
- Neutrophil count at least 2,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin, AST, and ALT no greater than 1.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.7 mg/dL
Cardiovascular:
- Ejection fraction at least 50% unless dysfunction attributable to lymphoma
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other concurrent serious uncontrolled medical conditions
- No other prior malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to more than 35% of hematopoietic sites
- Concurrent consolidation radiotherapy allowed
Surgery:
- Not specified
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005867
Show 46 study locations
| Study Chair: | Ruth Pettengell, MD | St. George's Hospital |
| ClinicalTrials.gov Identifier: | NCT00005867 |
| Other Study ID Numbers: |
BNLI-CHOPVPMITCEBO-GOODRISK CDR0000067900 ( Registry Identifier: PDQ (Physician Data Query) ) EU-99052 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | June 26, 2013 |
| Last Verified: | March 2007 |
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stage I grade 3 follicular lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult immunoblastic large cell lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse mixed cell lymphoma |
stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma contiguous stage II grade 3 follicular lymphoma contiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma |
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisolone Cyclophosphamide Doxorubicin Liposomal doxorubicin Etoposide Vincristine Mitoxantrone |
Bleomycin 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 Antineoplastic Agents, Phytogenic |