Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma - Full Text View

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:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

Drug Information available for: Dexamethasone Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Cytarabine Melphalan Carmustine Prednisolone phosphate Dexamethasone acetate Prednisolone sodium succinate Vincristine sulfate Methylprednisolone sodium succinate Dexamethasone sodium phosphate Melphalan hydrochloride Ifosfamide Dacarbazine Bleomycin sulfate Bleomycin Sulfate ion Cisplatin Doxorubicin Doxorubicin hydrochloride Etoposide Vinorelbine Gemcitabine Etoposide phosphate Gemcitabine hydrochloride Vinorelbine tartrate

U.S. FDA Resources

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

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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.

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

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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
Isophosphamide mustard
Gemcitabine
Vinorelbine
Carmustine
Cisplatin

Cytarabine
Dacarbazine
Dexamethasone
Etoposide
Ifosfamide
Melphalan
Mitoguazone
Methylprednisolone Hemisuccinate
Prednisolone
Vincristine
Vindesine
Vinblastine
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate

ClinicalTrials.gov processed this record on May 22, 2013