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A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin's Disease

Phase 3
15 Years
65 Years
Not Enrolling

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Trial Information

A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin's Disease


- Compare progression-free and overall survival of patients with stage III or IV
Hodgkin's disease treated with doxorubicin, bleomycin, vinblastine, and dacarbazine
with or without autologous peripheral blood stem cell transplantation and high-dose

- Compare the toxic effects of these treatment regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
number of poor prognostic factors (3 vs 4 vs 5) and stage of disease (III vs IV).

Patients receive induction chemotherapy consisting of doxorubicin IV over 5 minutes,
bleomycin IV over 10 minutes, vinblastine IV over 5 minutes, and dacarbazine IV over 15-30
minutes on days 1 and 15. Treatment repeats every 28 days for 5 courses in the absence of
disease progression or unacceptable toxicity. Patients who show at least partial response
after the fifth course of induction chemotherapy and whose blood counts have recovered are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive 3 additional courses of induction chemotherapy for a total of 8

- Arm II: Patients receive 1 additional course of induction chemotherapy followed by stem
cell collection. Patients then receive high-dose chemotherapy with carmustine IV over 2
hours on days -6 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on
day -2. Patients undergo autologous peripheral blood stem cell transplantation on day

Patients are followed at 60 days, every 3 months for 1 year, every 6 months for 2 years, and
then annually thereafter.

PROJECTED ACCRUAL: Approximately 460 patients will be accrued for this study within 4 years.

Inclusion Criteria


- Histologically confirmed stage III or IV Hodgkin's disease with at least 3 of the
following characteristics:

- Albumin less than 4.0 mg/dL

- Hemoglobin less than 10.5 g/dL

- Leukocytosis at least 15,000/mm^3

- Lymphocytopenia less than 600/mm^3 or less than 8% of total WBC

- Male sex

- At least 45 years of age

- Stage IV disease

- Bidimensionally measurable disease

- Bilateral or unilateral bone marrow aspiration and biopsy performed within 42 days of

- Negative chest x-ray within 42 days of study OR

- Chest x-ray performed within 28 days of study

- Negative CT scan of thorax, abdomen, and pelvis within 42 days of study OR

- CT scan of thorax, abdomen, and pelvis performed within 28 days of study

- No history of lymphoma, myelodyplastic syndrome, or leukemia

- No CNS involvement by Hodgkin's disease



- 15 to 65

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified


- See Disease Characteristics


- See Disease Characteristics

- Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless elevation due
to liver infiltration by Hodgkin's disease)

- Lymphoma-related hepatic dysfunction allowed


- Creatinine no greater than 2.0 times ULN

- Creatinine clearance at least 60 mL/min

- Lymphoma-related renal dysfunction allowed


- No coronary artery disease, cardiomyopathy, congestive heart failure, or arrhythmias
requiring therapy

- Ejection fraction normal

- No significant EKG abnormalities suggesting active cardiac disease


- Corrected DLCO at least 60% OR

- FEV1 at least 60% predicted


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No HIV or AIDS

- No other prior malignancy within past 5 years except adequately treated basal cell or
squamous cell skin cancer

- No active bacterial, fungal, or viral infection*

- Afebrile for 3 consecutive days* NOTE: *Prior to randomization portion of study


Biologic therapy:

- Not specified


- No prior chemotherapy for Hodgkin's disease except single course of ABVD
(doxorubicin, bleomycin, vinblastine, and dacarbazine) within 35 days of study

Endocrine therapy:

- Not specified


- No prior radiotherapy for Hodgkin's disease


- Not specified


- At least 3 days since prior antibiotics, antifungals, or antivirals (except for
prophylactic therapy or fever associated with underlying lymphoma) (for randomization
portion of study)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter

Safety Issue:


Principal Investigator

Ellen R. Gaynor, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University


United States: Federal Government

Study ID:




Start Date:

April 2000

Completion Date:

May 2005

Related Keywords:

  • Lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



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