NCT01304849

Use of Interim PET Scan to Modify Therapy in Advanced Hodgkin's Lymphoma in Order to Improve Outcomes

Phase II Study of Interim PET-CT Scan-guided Response Adapted Therapy in Hodgkin's Lymphoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Cancer Institute WIA · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The current standard treatment for advanced Hodgkin's lymphoma 6-8 cycles of ABVD chemotherapy-this cures 70-80% patients. Those not cured after 8 cycles of ABVD have a poor outcome (\<10% survival). More intensive chemotherapy like Escalated BEACOPP (EB) achieve higher cure rates have more side effects. Hence the investigators propose to use Interim PET CT scan (done after 2 cycles of ABVD) for early identification of poor responders (it is known that those with interim PET positive disease have a cure rate of less than 10-15% if continued with ABVD alone) and to use EB selectively in this population in an attempt to improve treatment outcomes - at the same time to limit side effects of therapy. Thus, this study is an attempt to improve the outcome in the small subset of poor responders to ABVD chemotherapy by the early use of Escalated BEACOPP chemotherapy

Conditions

• Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Escalated BEACOPP	Escalated BEACOPP chemotherapy will be delivered for those patients who are interim PET CT positive after 2 cycles of ABVD chemotherapy. The patients will receive 2-4 cycles of Escalated BEACOPP once in 3 weeks. The cycles will be delivered as follows: Bleomycin 10mg/m2 IV in day 8, Etoposide 200mg/m2 Day 1 to Day 3, Adriamycin 35mg/m2 on Day 1 IV, Cyclophosphamide 1200mg/m2 on Day 1 IV, Vincristine 1.4mg/m2 on Day 8 IV, Cap Procarbazine 100mg/m2 Day 1 to Day 7 PO, T Prednisolone 40mg D1-D7 of a 21 day cycle. With Inj Mesna 400mg/m2 0, 4 and 8 hours on the day of Cyclophosphamide Inj G-CSF will be started routinely from Day 9 till recovery of Absolute neutrophil counts ≥5000/cmm or Total WBC counts≥ 8000/cmm

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-02-28
• Last updated: 2015-02-04

Locations

1 site across 1 country: India