Dose-Dense ABVD Study: An accelerated delivery of Adriamycin, Bleomycin, Vinblastin and Dacarbazine for patients with Hodgkin Lymphoma
A Phase II Single Arm Study Assessing The Feasibility And Toxicity Of Dose-Dense ABVD In Patients With Early Stage Unfavourable And Advanced Stage Hodgkin Lymphoma.
Queensland Health
31 participants
Mar 1, 2012
Interventional
Conditions
Summary
This study will evaluate whether giving standard chemotherapy treatment more quickly can be done safely and will be more effective in treating patients with Hodgkin Lymphoma. Who is it for? You may be eligible to join this study if you are aged between 16-60 years and have been diagnosed with either early stage unfavourable or advanced stage Hodgkin Lymphoma. Trial details The current standard therapy for Hodgkin Lymphoma involves receiving a four drug chemotherapy regimen called 'ABVD' every fourteen days. ABVD is an abbreviation for the four drugs used (A=adriamycin, B=bleomycin, V=vinblastin, D=dacarbazine). This chemotherapy is generally well tolerated. A full cycle of therapy involves ABVD given on days 1 and 15 of a 28 day (=4 week) cycle. In this trial, all participants! will receive the exact same four drug combination (ABVD) but given on days 1 and 12 of a 21 day (=3 week) cycle. A growth factor called Nivestim will be given to accelerate the recovery of the body's normal blood cells from the effects of ABVD and thus allow the chemotherapy to be given more quickly than usual. Participants will undergo between 4 to 8 cycles of treatment depending on response. Participants will be regularly assessed over a period of up to 5 years to determine the safety and efficacy of this accelerated chemotherapy regime.
Eligibility
Inclusion Criteria6
- Confirmed histological diagnosis of Hodgkin Lymphoma
- Staging consistent with either early stage unfavourable or advanced stage disease according to the GHSG staging system
- ECOG performance status 0 to 2 inclusive
- No prior therapy for Hodgkin Lymphoma except for a short course of steroids for initial symptom control
- Written informed consent prior to study registration
- Patients of child bearing potential must use adequate contraception
Exclusion Criteria7
- Prior or current disease which prevents treatment with protocol chemotherapy
- Abnormal laboratory parameters (unless due to disease)
- Concurrent or previous malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or other solid tumours treated for cure with no evidence of disease for more than or equal to 2 years
- Presence of positive test results in human immunodeficiency virus (HIV), Hepatitis B (HB surface antigen [HBsAg], total HB core antibody [anti-HB-c]) and Hepatitis C (Hepatitis C virus [HCV] antibody) serology testing.
- Likely inability of the patient to comply with treatment assessments
- Pregnancy and lactation. Adults of reproductive potential must agree to use an effective method of birth control during treatment and for at least 3 months thereafter
- Prior solid organ transplantation
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Interventions
For early stage unfavourable disease: 4 cycles of ABVD plus 30.6Gy IF-XRT (extended field radiation therapy) Adriamycin at 25mg/m2 intravenous on day 1 and 12 of a 21 day cycle Bleomycin at 10,000 IU/m2 intravenous on day 1 and 12 of a 21 day cycle Vinblastine at 6mg/m2 intravenous on day 1 and 12 of a 21 day cycle Dacarbazine at 375mg/m2 intravenous on day 1 and 12 of a 21 day cycle Nivestim at 300 microgram subcutaneous on days 4-8 and 15-19 of a 21 day cycle CT restaging after chemotherapy should take place 2 weeks of the end of chemotherapy with irradiation ( 30.6Gy IF-XRT in 17 fractions at 5/week using 1.8Gy daily dose) beginning after recovery of blood counts (ANC > 1.0 x 109/L, platelets > 75), 4 weeks if possible but at most 6 weeks after the end of chemotherapy. For advanced stage: 6-8 cycles of ABVD Adriamycin at 25mg/m2 intravenous on day 1 and 12 of a 21 day cycle Bleomycin at 10,000 IU/m2 intravenous on day 1 and 12 of a 21 day cycle Vinblastine at 6mg/m2 intravenous on day 1 and 12 of a 21 day cycle Dacarbazine at 375mg/m2 intravenous on day 1 and 12 of a 21 day cycle Nivestim at 300 microgram subcutaneous on days 4-8 and 15-19 of a 21 day cycle Advanced stage patients who are in CR or Cru after interim CT restaging (i.e. after 3 or 4 cycles) are to receive 6 cycles whereas those with ongoing response between interim CT restaging and CT staging after 6 cycles should go on to receive a further 2 cycles of ABVD to a total of 8 cycles.
Locations(1)
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ACTRN12612000137897