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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00920153
Enrollment
442
Registered
2009-06-15
Start date
2008-05-31
Completion date
2016-03-31
Last updated
2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma

Brief 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.

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.

Interventions

BIOLOGICALbleomycin sulfate

Given IV

Given IV

DRUGcarmustine

Given IV

DRUGcisplatin

Given IV

DRUGcytarabine

Given IV

DRUGdacarbazine

Given IV

DRUGdexamethasone

Given orally

DRUGdoxorubicin hydrochloride

Given IV

DRUGetoposide

Given IV

DRUGgemcitabine hydrochloride

Given IV

DRUGifosfamide

Given IV

DRUGmelphalan

Given IV

DRUGmethylprednisolone

Given IV

Given IV

DRUGvincristine sulfate

Given IV

DRUGvindesine

Given IV

DRUGvinorelbine tartrate

Given IV

PROCEDUREallogeneic hematopoietic stem cell transplantation

Patients undergo allogeneic stem cell transplantation

PROCEDUREautologous hematopoietic stem cell transplantation

Patients undergo autologous stem cell transplantation

Sponsors

French Innovative Leukemia Organisation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Event-free survivaltreatments evaluationevent free survival

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026