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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: bleomycin sulfate (Biological); 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 (Drug); allogeneic hematopoietic stem cell transplantation (Procedure); autologous hematopoietic stem cell transplantation (Procedure)

Phase: Phase 3

Status: Recruiting

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

Official(s) and/or principal investigator(s):
Delphine Senecal, Principal Investigator, Affiliation: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

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.

Clinical Details

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

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Event-free survival

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Groupe Ouest Est d'etude des Leucemies et Autres Maladies du Sang, Besancon Cedex 25030, France; Recruiting
Delphine Senecal, Phone: 33-2-4739-1896
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 2008
Last updated: February 23, 2011

Page last updated: August 20, 2015

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