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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 810
Study Start Date: May 2008
Estimated Primary Completion Date: May 2015 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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
Groupe Ouest Est d'etude des Leucemies et Autres Maladies du Sang Recruiting
Besancon Cedex, France, 25030
Contact: Delphine Senecal    33-2-4739-1896      
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Investigators
Principal Investigator: Delphine Senecal Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00920153     History of Changes
Other Study ID Numbers: CDR0000633503, GOELAMS-LH2007, GOELAMS-ID-RCB#2007-A01079-44, INCA-RECF0754, AMGEN-GOELAMS-LH2007
Study First Received: June 12, 2009
Last Updated: February 23, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Liposomal doxorubicin
Isophosphamide mustard
Gemcitabine
Vinorelbine
Carmustine
Cisplatin
Cytarabine
Dacarbazine
Dexamethasone
Etoposide
Ifosfamide
Melphalan
Mitoguazone
Methylprednisolone Hemisuccinate
Prednisolone
Vincristine
Vindesine
Vinblastine
Dexamethasone acetate
Methylprednisolone acetate

ClinicalTrials.gov processed this record on August 01, 2014