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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00920153
• Other study ID #: LH 2007
• Status: Terminated
• Phase: Phase 3
• First received: June 12, 2009
• Last updated: September 15, 2016
• Start date: May 2008
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 442
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Biological:
• bleomycin sulfate
Given IV

Drug:
• ABVD regimen
Given IV
• carmustine
Given IV
• cisplatin
Given IV
• cytarabine
Given IV
• dacarbazine
Given IV
• dexamethasone
Given orally
• doxorubicin hydrochloride
Given IV
• etoposide
Given IV
• gemcitabine hydrochloride
Given IV
• ifosfamide
Given IV
• melphalan
Given IV
• methylprednisolone
Given IV
• mitoguazone
Given IV
• vincristine sulfate
Given IV
• vindesine
Given IV
• vinorelbine tartrate
Given IV

Procedure:
• allogeneic hematopoietic stem cell transplantation
Patients undergo allogeneic stem cell transplantation
• autologous hematopoietic stem cell transplantation
Patients undergo autologous stem cell transplantation

Locations

Country	Name	City	State
France	FILO French Innovative Leukemia Organization	Tours Cedex

Sponsors (1)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	event free survival	treatments evaluation	Yes