CompletedPhase 3ACTRN12610000927022

A randomised Phase III Trial to assess response adapted therapy using 2-[F-18]fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma

Sponsor

University College

Enrollment

1,200 participants

Start Date

Sep 9, 2010

Study Type

Interventional

Conditions

Hodgkin Lymphoma

Summary

This study looks at the effectiveness of using fluoro-deoxy-glucose positron emission tomography (FDG-PET) imaging to guide therapy in people with newly diagnosed, advanced Hodgkin lymphoma. Who is it for? You may be able to join this study if you have previously untreated advanced Hodgkin lymphoma and are over 18 years of age. Trial details Participants receive 2 cycles of the standard chemotherapy regimen (ABVD) and then have a FDG-PET scan, which provides a 3 dimensional image of the lymphoma. Depending on the results of this and future scans, participants are assigned different courses of chemotherapy at various stages during the trial. The trial aims to see how the different treatments, which are guided by the results of FDG-PET imaging, affect survival rates, and also monitors any toxic effects of treatment.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria16

Histologically confirmed classical Hodgkin lymphoma (HL) according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted). All histology will be reviewed by a central pathology panel for the group concerned
Aged 18 or above
Clinical stage IIB, IIIA, IIIB or IV, or Clinical stage IIA with adverse features:
bulk mediastinal disease, defined as maximal transverse diameter of mass >0.33 of the internal thoracic diameter at D5/6 interspace on routine chest X-ray
outside the mediastinum, lymph node or lymph node mass greater than 10cm in diameter
more than two sites of disease
other poor risk features as a result of which it is considered necessary to treat with full course combination chemotherapy
No previous chemotherapy, radiotherapy or other investigational drug for HL
Performance status 0-3
Adequate bone marrow function with platelets > 100x10e9/l; neutrophils > 1.5x10e9/l at the time of study entry unless lower numbers are attributed to bone marrow infiltration by lymphoma
Serum creatinine less than 150% of the upper limit of normal, serum bilirubin less than twice the upper limit of normal and transaminases < 2.5× upper limit of normal unless attributed to lymphoma
Patients with a significant history of ischaemic heart disease or hypertension must have an acceptable left ventricular ejection fraction (LVEF) =50%
Life expectancy > 3 months
All patients of childbearing potential are willing to use adequate contraceptive precautions
Written, informed consent
Access to PET-CT scanning

Exclusion Criteria10

Poorly controlled Diabetes mellitus
Other concurrent uncontrolled medical condition
Pregnant or lactating
Known central nervous system or meningeal involvement by the lymphoma
Cardiac contra-indication to doxorubicin: abnormal contractility on echocardiography or nuclear medicine examination (MUGA)
Neurological contra-indication to chemotherapy (e.g. pre-existing neuropathy)
General status that does not allow the administration of a full course of chemotherapy according to the investigator
Previous history of active malignant disease other than fully excised basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the last 10 years
Known positive serology for human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C (but no requirement for routine testing in the absence of risk factors)
Medical or psychiatric conditions that compromise the patient’s ability to give informed consent

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Interventions

Subjects follow different treatment courses depending on outcomes of Positron Emission Tomography (PET) scans at various stage during the trial. The drugs used in treatment are as follows: bleo

Subjects follow different treatment courses depending on outcomes of Positron Emission Tomography (PET) scans at various stage during the trial. The drugs used in treatment are as follows: bleomycin sulfate filgrastim pegfilgrastim cyclophosphamide dacarbazine doxorubicin hydrochloride etoposide prednisolone procarbazine hydrochloride vinblastine vincristine sulfate Subjects undergo 2 cycles of ABVD and then have a PET scan. PET negative patients are subsequently randomised between ABVD for 4 cycles of AVD (25mg/m2 doxorubicin intravenously (i.v) days 1,15; 6mg/m2 vinblastine i.v days 1,15; Dacarbazine 375mg/m2 i.v days 1,15) for 4 cycles, before progressing to response assessment. PET positive patients undergo either 4-6 14 day cycles of BEACOPP-14 (25mg/m2 doxorubicin iv day 1; cyclophosphamide 650mg/m2 iv day 1; Etoposide 100mg/m2 i.v days 1-3; Procarbazine 100mg/m2 per oral (po) days 1-7; Prednisolone 80mg/m2 po days 1-7; Bleomycin 10,000units/m2 i.v day 8; vincristine 1.4-2mg i.v day 8; G-CSF 263/300mcg subcutaneously (s.c) days 9-13 or Peg filgastrim single dose) or 3-4 cycles of 21 day BEACOPP escalated (35mg/m2 doxorubicin i.v day 1; cyclophosphamide 1250mg/m2 i.v day 1; Etoposide 200mg/m2 i.v days 1-3; Procarbazine 100mg/m2 po days 1-7; Prednisolone 40mg/m2 po days 1-14; Bleomycin 10,000units/m2 i.v day 8; vincristine 1.4-2mg i.v day 8; G-CSF 263/300mcg s.c days 9-13 or Peg filgastrim single dose)(choice of therapy determined in advance by centre) before progressing to another PET scan. PET negative patients on this scan undergo either 2 cycles of BEACOPP-14 or 1 more cycle of BEACOPP-escalated. PET positive patients have either radiation or salvage therapy at Investigator discretion before progressing to response assessment.