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

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ClinicalTrials.gov Identifier: NCT00920153
Recruitment Status : Terminated (Other new drugs)
First Posted : June 15, 2009
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
French Innovative Leukemia Organisation

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: bleomycin sulfate Drug: ABVD regimen Drug: carmustine Drug: cisplatin Drug: cytarabine Drug: dacarbazine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: gemcitabine hydrochloride Drug: ifosfamide Drug: melphalan Drug: methylprednisolone Drug: mitoguazone Drug: vincristine sulfate Drug: vindesine Drug: vinorelbine tartrate Procedure: allogeneic hematopoietic stem cell transplantation Procedure: autologous hematopoietic stem cell transplantation Phase 3

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Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 442 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma
Study Start Date : May 2008
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 (favorable prognosis)
Patients receive ABVD and VABEM chemotherapy.
Biological: bleomycin sulfate
Given IV

Drug: ABVD regimen
Given IV

Drug: carmustine
Given IV

Drug: dacarbazine
Given IV

Drug: doxorubicin hydrochloride
Given IV

Drug: etoposide
Given IV

Drug: methylprednisolone
Given IV

Drug: vincristine sulfate
Given IV

Drug: vindesine
Given IV

Experimental: Group 2 (intermediate prognosis)
Patients receive ABVD and VABEM chemotherapy.
Biological: bleomycin sulfate
Given IV

Drug: ABVD regimen
Given IV

Drug: carmustine
Given IV

Drug: dacarbazine
Given IV

Drug: doxorubicin hydrochloride
Given IV

Drug: etoposide
Given IV

Drug: methylprednisolone
Given IV

Drug: vincristine sulfate
Given IV

Drug: vindesine
Given IV

Experimental: Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
Drug: carmustine
Given IV

Drug: cisplatin
Given IV

Drug: cytarabine
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: 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




Primary Outcome Measures :
  1. Event-free survival [ Time Frame: treatments evaluation ]
    event free survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • 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

EXCLUSION CRITERIA:

  • No concurrent participation in another experimental trial

Information from the National Library of Medicine

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): NCT00920153


Locations
France
FILO French Innovative Leukemia Organization
Tours Cedex, France, 37044
Sponsors and Collaborators
French Innovative Leukemia Organisation
Investigators
Principal Investigator: Delphine Senecal French Innovative Leukemia Organization

Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT00920153     History of Changes
Other Study ID Numbers: LH 2007
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by French Innovative Leukemia Organisation:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Dexamethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Gemcitabine
Vinorelbine
Liposomal doxorubicin
Doxorubicin
Etoposide
Cytarabine
Vincristine
Melphalan
Ifosfamide
Bleomycin
Carmustine
Vindesine
Mitoguazone
Anti-Inflammatory Agents