Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11)

Hodgkin Lymphoma Clinical Trial

— H11  

Official title:

Very Early FDG-PET/CT-response Adapted Therapy for Advanced Stage Hodgkin Lymphoma, a Randomized Phase III Non-inferiority Study of the EORTC Lymphoma Group

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01652261
• Other study ID #: EORTC-20101-23101
• Secondary ID: 2011-005473-22
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: June 2014
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) in case of a positive fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) after one cycle of ABVD, has non-inferior efficacy compared with the intensive BEACOPPesc regimen. A second objective is to assess the prognostic value of FDG-PET/CT after one cycle of BEACOPPesc.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria:

• Previously untreated, histologically proven classical Hodgkin lymphoma

• Clinical stages III/IV (Ann Arbor)

• Age 18-60

• WHO performance 0-2

• Adequate organ function

• Patients of childbearing/reproductive potential should use adequate birth control measures during the whole duration of study treatment.

• Written informed consent according to ICH/EU Good Clinical Practice, and national/local regulations

Exclusion criteria:

• Pregnancy or lactation

• Specific contraindications to BEACOPPesc therapy, including:

• Poorly controlled diabetes mellitus

• HIV infection,

• Chronic active hepatitis B and/or hepatitis C

• Concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for >5 years

• Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Drug:
• ABVD + FDG-PET/CT Scan treatment adaptation

• BEACOPPesc

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	Polish Lymphoma Research Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from treatment failure		9 years after first patient in (FPI)
Secondary	response at the end of therapy		9 years after FPI
Secondary	Progression-free survival		9 years after FPI
Secondary	Overall survival		9 years after FPI
Secondary	Acute toxicity	Hematological toxicity (blood cell count) can be significant especially for patients who will receive BEACOPPesc .; Bleomycine interstitial pneumonitis has been frequently reported and requires the immediate stop of further bleomycine administration.; Rarely, procarbazine allergy and intolerance has been reported.; Nausea & vomiting due to cyclophosphamide, doxorubicin, dacarbazine and procarbazine may be significant.; Total reversible alopecia occurs in most cases.; Escalated BEACOPP-related toxic deaths have been reported but do not exceed those observed with standard ABVD.	9 years after FPI
Secondary	Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events		9 years after FPI