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Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma


Phase 3
18 Years
59 Years
Not Enrolling
Both
Lymphoma

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Trial Information

Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive
non-Hodgkin's lymphoma of 1 of the following types:

- Working formulation:

- Follicular large cell

- Diffuse mixed cell

- Diffuse large cell

- Diffuse immunoblastic OR

- REAL classification:

- Diffuse large B-cell

- Peripheral T-cell

- Measurable or evaluable disease

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)

Safety Issue:

No

Principal Investigator

Ruth Pettengell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. George's Hospital

Authority:

United States: Federal Government

Study ID:

BNLI-CHOPVPMITCEBO-GOODRISK

NCT ID:

NCT00005867

Start Date:

January 1998

Completion Date:

August 2007

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

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