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

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT00920153
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • bleomycin sulfate — BIOLOGICAL
    Given IV
  • ABVD regimen — DRUG
    Given IV
  • carmustine — DRUG
    Given IV
  • cisplatin — DRUG
    Given IV
  • cytarabine — DRUG
    Given IV
  • dacarbazine — DRUG
    Given IV
  • dexamethasone — DRUG
    Given orally
  • doxorubicin hydrochloride — DRUG
    Given IV
  • etoposide — DRUG
    Given IV
  • gemcitabine hydrochloride — DRUG
    Given IV
  • ifosfamide — DRUG
    Given IV
  • melphalan — DRUG
    Given IV
  • methylprednisolone — DRUG
    Given IV
  • mitoguazone — DRUG
    Given IV
  • vincristine sulfate — DRUG
    Given IV
  • vindesine — DRUG
    Given IV
  • vinorelbine tartrate — DRUG
    Given IV
  • allogeneic hematopoietic stem cell transplantation — PROCEDURE
    Patients undergo allogeneic stem cell transplantation
  • autologous hematopoietic stem cell transplantation — PROCEDURE
    Patients undergo autologous stem cell transplantation

Study Details

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.

Key Dates

Start date
May 31, 2008
Status verified
Jul 2016
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
442 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 (favorable prognosis)
    Patients receive ABVD and VABEM chemotherapy.
  • Experimental: Group 2 (intermediate prognosis)
    Patients receive ABVD and VABEM chemotherapy.
  • Experimental: Group 3 (poor prognosis)
    Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.

Primary Outcome Measure

Event-free survival [ Time Frame: treatments evaluation ]

Related Studies