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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


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Safety Issue:

No

Principal Investigator

Delphine Senecal

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Authority:

Unspecified

Study ID:

CDR0000633503

NCT ID:

NCT00920153

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

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