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Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage II Hodgkin's Lymphoma

This study has been completed.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: July 8, 2004
Last updated: September 28, 2013
Last verified: September 2013

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vinblastine, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage I or stage II Hodgkin's lymphoma.

Condition Intervention Phase
Drug: doxorubicin hydrochloride
Drug: gemcitabine hydrochloride
Drug: vinblastine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: May 2004
Study Completion Date: May 2011
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: doxorubicin hydrochloride
    given IV
    Drug: gemcitabine hydrochloride
    given IV
    Drug: vinblastine
    given IV
Detailed Description:



  • Determine the complete response rate in patients with newly diagnosed stage IA, IB, IIA, or IIB non-bulky Hodgkin's lymphoma treated with doxorubicin, vinblastine, and gemcitabine.


  • Determine the event-free survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine whether fludeoxyglucose F 18 positron-emission tomography scanning is useful in predicting clinical relapse and determining the presence of residual disease in these patients after treatment with this regimen.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo fludeoxyglucose F 18 positron-emission tomography (PET) scanning and CT scan before treatment and after courses 2 and 6 of therapy to assess response. Patients with a positive PET scan after completion of study therapy may undergo biopsy. A PET scan is performed 3 months later if biopsy is negative or biopsy is unable to be performed.

Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 98 patients will be accrued for this study within 3 years.


Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed non-bulky Hodgkin's lymphoma

    • Clinical stage IA, IB, IIA, or IIB
    • "E" extensions allowed if all other criteria are met
  • Measurable disease

    • At least 1 unidimensionally measurable lesion > 2 cm by CT scan or MRI OR ≥ 1.5 cm by spiral CT scan
    • The following are considered non-measurable:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural or pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis or pulmonis
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions
      • Lesions in a previously irradiated area
  • Bone marrow biopsy required
  • No mediastinal mass that is > one-third of the maximum intrathoracic diameter on a standing posterior-anterior chest x-ray
  • No peripheral or retroperitoneal adenopathy > 10 cm in its largest diameter
  • No nodular lymphocyte predominant Hodgkin's lymphoma



  • 16 and over

Performance status

  • CTC 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 2 mg/dL
  • AST ≤ 2 times upper limit of normal


  • Creatinine ≤ 2 mg/dL


  • LVEF normal by echocardiogram or MUGA


  • DLCO ≥ 60% with no symptomatic pulmonary disease


  • HIV negative
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy

  • No concurrent pegfilgrastim


  • No prior chemotherapy for Hodgkin's lymphoma
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent hormone therapy except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes)


  • See Disease Characteristics
  • No prior radiotherapy for Hodgkin's lymphoma


  • Not specified


  • No other prior treatment for Hodgkin's lymphoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00086801

  Show 47 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Study Chair: David J. Straus, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Kostakoglu L, Straus DJ, Schöder H, et al.: Validation of the International Harmonization Project (IHP) Guidelines in early stage Hodgkin lymphoma (HL) treated with adriamycin, vinblastine and gemcitabine (AVG) (CALGB 50203): early results. [Abstract] Blood 112 (11): A-1460, 2008.
Straus D, LaCase A, Juweid M, et al.: Doxorubicin, vinblastine and gemcitabine (AVG), a novel regimen excluding bleomycin for the treatment of early stage Hodgkin lymphoma (HL): results of CALGB 50203. [Abstract] Blood 110 (11): A-214, 2007.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00086801     History of Changes
Other Study ID Numbers: CDR0000370870, U10CA031946, CALGB-50203
Study First Received: July 8, 2004
Last Updated: September 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Liposomal doxorubicin
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors processed this record on November 20, 2014