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

This study has been terminated.
(Other new drugs)
Sponsor:
Information provided by (Responsible Party):
French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier:
NCT00920153
First received: June 12, 2009
Last updated: September 15, 2016
Last verified: July 2016
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by French Innovative Leukemia Organisation:

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


Enrollment: 442
Study Start Date: May 2008
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (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
  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 ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT00920153     History of Changes
Other Study ID Numbers: LH 2007
Study First Received: June 12, 2009
Last Updated: September 15, 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

ClinicalTrials.gov processed this record on September 21, 2017