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

This study has been withdrawn prior to enrollment.

(Study closed due to lack of recruitment)

Sponsor:

Collaborator:

Polish Lymphoma Research Group

Information provided by (Responsible Party):

European Organisation for Research and Treatment of Cancer - EORTC

ClinicalTrials.gov Identifier:

NCT01652261

First received: July 18, 2012

Last updated: June 13, 2014

Last verified: June 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Hodgkin Lymphoma	Drug: ABVD + FDG-PET/CT Scan treatment adaptation Drug: BEACOPPesc	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hodgkin Disease Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Hodgkin Lymphoma

U.S. FDA Resources

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:

Freedom from treatment failure [ Time Frame: 9 years after first patient in (FPI) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

response at the end of therapy [ Time Frame: 9 years after FPI ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: 9 years after FPI ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 9 years after FPI ] [ Designated as safety issue: No ]
Acute toxicity [ Time Frame: 9 years after FPI ] [ Designated as safety issue: Yes ]
- 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.
Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events [ Time Frame: 9 years after FPI ] [ Designated as safety issue: Yes ]


Enrollment:	0
Study Start Date:	May 2013
Estimated Study Completion Date:	March 2022
Estimated Primary Completion Date:	March 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: experimental arm An experimental arm (early FDG-PET/CT-response adapted), where all patients are initially treated with a single cycle of ABVD. Very early FDG-PET/CT-negative patients continue on ABVD therapy to a total of six cycles. Very early FDG-PET/CT-positive patients receive 3 cycles of BEACOPPesc followed by another 3 cycles of BEACOPPesc. Mid-treatment evaluation is performed after 4 cycles. In case of treatment failure (less than partial remission (PR)), the patient goes off protocol treatment. Only patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)).	Drug: ABVD + FDG-PET/CT Scan treatment adaptation Drug: BEACOPPesc
Active Comparator: standard arm A standard arm, where patients are treated with four cycles of BEACOPPesc followed by 2 cycles of BEACOPPesc. FDG-PET/CT is performed after one cycle, but with no therapeutic consequences. Mid-treatment evaluation is performed after four cycles. In case of treatment failure (less than PR), the patient goes off protocol treatment. Only patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)).	Drug: BEACOPPesc

Arms

Assigned Interventions

Experimental: experimental arm

An experimental arm (early FDG-PET/CT-response adapted), where all patients are initially treated with a single cycle of ABVD. Very early FDG-PET/CT-negative patients continue on ABVD therapy to a total of six cycles. Very early FDG-PET/CT-positive patients receive 3 cycles of BEACOPPesc followed by another 3 cycles of BEACOPPesc. Mid-treatment evaluation is performed after 4 cycles. In case of treatment failure (less than partial remission (PR)), the patient goes off protocol treatment.

Only patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)).

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

Active Comparator: standard arm

A standard arm, where patients are treated with four cycles of BEACOPPesc followed by 2 cycles of BEACOPPesc. FDG-PET/CT is performed after one cycle, but with no therapeutic consequences. Mid-treatment evaluation is performed after four cycles. In case of treatment failure (less than PR), the patient goes off protocol treatment.

Only patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)).

Drug: BEACOPPesc

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652261

Locations


Denmark
Rigshospitalet
Copenhagen, Denmark, 2100

Sponsors and Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Polish Lymphoma Research Group

Investigators


Study Chair:	Martin Hutchings	Rigshospitalet, Denmark
Study Chair:	Berthe Aleman	The Netherlands Cancer Institute, Amsterdam, The Netherlands
Study Chair:	Gustaaf van IMHOFF	University Medical Center Groningen
Study Chair:	Wim Oyen	Radboud University

More Information


Responsible Party:	European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:	NCT01652261 History of Changes
Other Study ID Numbers:	EORTC-20101-23101 2011-005473-22
Study First Received:	July 18, 2012
Last Updated:	June 13, 2014
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:


advanced stage

Additional relevant MeSH terms:


Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms	Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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