HD21 : Treatment optimisation trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 6 cycles of escalated BEACOPP with 6 cycles of BrECADD

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18-60Age 18-60

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaHodgkin's Disease (Hodgkin's Lymphoma)

Trial Overview Read MoreRead more

This phase III trial is comparing two 6-cycle chemotherapy treatments (BEACOPP and BrECADD) in the first-line treatment of advanced Hodgkin's Lymphoma.
 

This trial is treating patients with Hodgkin's Disease (Hodgkin's Lymphoma).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

Treatment optimisation trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 6 cycles of escalated BEACOPP with 6 cycles of BrECADD

Commercial Sponsor

Millennium Pharmaceuticals, Inc.

Summary

Patients will be randomised in a 1:1 ratio to either arm1 or arm2. Arm1 (standard group): Patients will receive 6 cycles of the escalated BEACOPP regimen as follows- Cyclophosphamide (1250 mg/m^2, IV over 60 minute infusion, day 1); Adriamycin (35 mg/m^2, IV over 30 minute infusion, day 1); Etoposide (200 mg/m^2 per day, IV over 60 minute infusion, day 1 to day 3); Procarbazine (100 mg/m^2 per day, oral capsule, day 1 to day 7); Prednisone (40 mg/m^2 per day, oral tablet, day 1 to day 14); Vincristine (1.4 mg/m^2, IV bolus, day 8); Bleomycin (10 mg/m^2, IV bolus, day 8); Pegylated G-CSF ( 6 mg, subcutaneous injection, day 4). Each cycle is 21 days. Arm2 (experimental group): Patients will receive 6 cycles of the BrECADD regimen as follows- Brentuximab vedotin (1.8 mg/kg, IV over 30 minute infusion, day 1); Cyclophosphamide (1250 mg/m^2, IV over 60 minute infusion, day 2); Adriamycin (40 mg/m^2, IV over 30 minute infusion, day 2); Etoposide (150 mg/m^2 per day, IV over 60 minute infusion, day 2 to day 4); Dacarbazine (250 mg/m^2 per day, IV over 120 minute infusion, day 3 to day 4); Dexamethasone (40 mg/m^2 per day, oral tablet, day 2 to day 5); Pegylated G-CSF (6 mg, subcutaneous injection, day 5). Each cycle is 21 days. In both groups, restaging will take place in the last week of the second treatment cycle (“PET-2”), at the end of chemotherapy (“PET-6”), and at the end of radiotherapy if given (restaging after radiotherapy). In both groups, PET-2 is to take place in the last week of the 2nd chemotherapy cycle (between day 17 and day 21) PET-6 is to take place within 3 weeks after day 21 of the 6th chemotherapy cycle. Patients will undergo restaging by FDG-PET with low dose CT, of the whole trunk of the body; images of the lower extremities are only required if a primary tumour was located there. Each restaging will always include an examination of all initially involved lymph nodes or organs using adequate methods. The objective of the PET-2 interim restaging is to document the response to chemotherapy, and to reassess if the patient is still qualified for the trial. The objective of the PET-6 restaging is to document the response to chemotherapy, and to recommend patients for radiotherapy where tumour masses are greater than or equal to 2.5 cm after chemotherapy. If a patient is scheduled for radiotherapy following PET-6 restaging, an additional FDG-PET will take place within 6 weeks after completion of radiotherapy. The decision and organisation of the radiotherapy is up to the discretion of the treating physician on site.

Recruiting Hospitals Read MoreRead more

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

Monash Health Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@southernhealth.org.au
03 9594 4044

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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