Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma

This study is currently recruiting participants.
Verified April 2010 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00920153
First received: June 12, 2009
Last updated: February 23, 2011
Last verified: April 2010

June 12, 2009
February 23, 2011
May 2008
May 2015   (final data collection date for primary outcome measure)
Event-free survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00920153 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma
Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrene at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs in different combinations may kill more cancer cells. It is not yet know which treatment regimen is more effective in treating Hodgkin lymphoma.

PURPOSE: This phase III trial is studying three different therapy regimens to compare how well they work in treating patients with previously untreated Hodgkin lymphoma.

OBJECTIVES:

Primary

  • Evaluate event-free survival.

Secondary

  • Evaluate overall survival.
  • Evaluate the prognostic value of FDG-PET scanning.
  • Evaluate progression-free survival.
  • Evaluate tolerability.
  • Evaluate rate of relapse.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment groups according to prognosis.

  • Group 1 (favorable prognosis): Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin sulfate IV, vincristine sulfate IV, dacarbazine IV, and methylprednisolone IV on days 1 and 14. Treatment repeats every 28 days for 2 courses. Patients then undergo PET scan for evaluation of response. Patients receive additional treatment according to response.

    • Favorable response: Patients with favorable response receive 1 additional course of ABVD chemotherapy.
    • Unfavorable response: Patients with unfavorable response receive 1 course of VABEM chemotherapy comprising vindesine IV continuously on days 1-5, doxorubicin hydrochloride IV continuously on days 1-3, carmustine IV on day 3, etoposide IV on days 3-5, and methylprednisolone IV on days 1-5.
  • Group 2 (intermediate prognosis): Patients receive 2 courses of ABVD chemotherapy. Patients then undergo PET scan for evaluation of response. Patients receive additional treatment according to response.

    • Favorable response: Patients with favorable response receive 4 additional courses of ABVD chemotherapy.
    • Unfavorable response: Patients with unfavorable response receive VABEM chemotherapy. Treatment with VABEM chemotherapy repeats every 28 days for 2 courses.
  • Group 3 (poor prognosis): Patients receive 2 courses of VABEM chemotherapy. Patients then undergo PET scan for evaluation of response. Patients receive additional treatment according to response.

    • Favorable response: Patients with favorable response receive 1 additional course of VABEM chemotherapy.
    • Unfavorable response: Patients with unfavorable response receive CEO chemotherapy comprising cisplatin IV continuously on days 1-3, gemcitabine hydrochloride IV on days 1 and 8, and oral dexamethasone once daily on days 1-4. Treatment repeats every 21 days for 3 courses. Patients then undergo PET scan. Patients receive additional treatment according to response.

      • Favorable response: Patients with favorable response receive BEAM chemotherapy comprising carmustine IV on day -7, etoposide IV and cytarabine IV on days -6 to -3, and melphalan IV on day -2. Patients then undergo autologous stem cell transplantation on day 0.
      • Unfavorable response: Patients with unfavorable response receive MINE chemotherapy comprising mitoguazone IV, vinorelbine ditartrate IV, and ifosfamide IV on days 1-5 and etoposide IV on days 1-3. Treatment repeats every 28 days for 3 courses. Patients then undergo allogeneic or autologous stem cell transplantation.

Patients with favorable response or a "bulky" mass at diagnosis may also undergo radiotherapy.

After completion of study treatment, patients are followed periodically for 15 years.

Interventional
Phase 3
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Biological: bleomycin sulfate
    Given IV
  • Drug: ABVD regimen
    Given IV
  • Drug: carmustine
    Given IV
  • Drug: cisplatin
    Given IV
  • Drug: cytarabine
    Given IV
  • Drug: dacarbazine
    Given IV
  • Drug: dexamethasone
    Given orally
  • Drug: doxorubicin hydrochloride
    Given IV
  • Drug: etoposide
    Given IV
  • Drug: gemcitabine hydrochloride
    Given IV
  • Drug: ifosfamide
    Given IV
  • Drug: melphalan
    Given IV
  • Drug: methylprednisolone
    Given IV
  • Drug: mitoguazone
    Given IV
  • Drug: vincristine sulfate
    Given IV
  • Drug: vindesine
    Given IV
  • Drug: vinorelbine tartrate
    Given IV
  • Procedure: allogeneic hematopoietic stem cell transplantation
    Patients undergo allogeneic stem cell transplantation
  • Procedure: autologous hematopoietic stem cell transplantation
    Patients undergo autologous stem cell transplantation
  • Experimental: Group 1 (favorable prognosis)
    Patients receive ABVD and VABEM chemotherapy.
    Interventions:
    • Biological: bleomycin sulfate
    • Drug: ABVD regimen
    • Drug: carmustine
    • Drug: dacarbazine
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: methylprednisolone
    • Drug: vincristine sulfate
    • Drug: vindesine
  • Experimental: Group 2 (intermediate prognosis)
    Patients receive ABVD and VABEM chemotherapy.
    Interventions:
    • Biological: bleomycin sulfate
    • Drug: ABVD regimen
    • Drug: carmustine
    • Drug: dacarbazine
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: methylprednisolone
    • Drug: vincristine sulfate
    • Drug: vindesine
  • Experimental: Group 3 (poor prognosis)
    Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
    Interventions:
    • Drug: carmustine
    • Drug: cisplatin
    • Drug: cytarabine
    • Drug: dexamethasone
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: gemcitabine hydrochloride
    • Drug: ifosfamide
    • Drug: melphalan
    • Drug: methylprednisolone
    • Drug: mitoguazone
    • Drug: vindesine
    • Drug: vinorelbine tartrate
    • Procedure: allogeneic hematopoietic stem cell transplantation
    • Procedure: autologous hematopoietic stem cell transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
810
Not Provided
May 2015   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of Hodgkin lymphoma

    • Previously untreated disease
    • No nodular lymphocyte predominant lymphoma

PATIENT CHARACTERISTICS:

  • Life expectancy > 3 months
  • LVEF normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be able to undergo follow-up for ≥ 15 years
  • No impaired cardiac function that would preclude the administration of an anthracycline
  • No other prior or concurrent malignancy, except for carcinoma in situ of the cervix or basal cell skin cancer
  • No respiratory, kidney, or liver failure or other severe clinical insufficiency that would preclude study treatment
  • No HIV or hepatitis B virus positivity
  • No other disease that would preclude treatment with chemotherapy or radiotherapy

PRIOR CONCURRENT THERAPY:

  • No concurrent participation in another experimental trial
Both
18 Years to 65 Years
No
Not Provided
France
 
NCT00920153
CDR0000633503, GOELAMS-LH2007, GOELAMS-ID-RCB#2007-A01079-44, INCA-RECF0754, AMGEN-GOELAMS-LH2007
Not Provided
Not Provided
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Not Provided
Principal Investigator: Delphine Senecal Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
National Cancer Institute (NCI)
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP