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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary | Experimental | Patients with aHL will receive 2 cycles of ABVD and undergo interim PET-2 scan- those with positive scans will receive 4 additional cycles of Esc BEACOPP while those with negative scans will receive 4 additional cycles of ABVD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escalated BEACOPP | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of interim PET guided therapy strategy interms of EFS in advanced HL | This is a phase II design looking at the efficacy of response adapted therapy delivering Esc BEACOPP in select patients with positive interim PET CT while PET negative patients continue to receive ABVD | Once in a year |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of escalated BEACOPP | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prasanth Ganesan, MD, DM | Cancer Institute (WIA) , Adyar, Chennai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology, Cancer Institute (WIA), Adyar | Chennai | Tamil Nadu | 600020 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25701453 | Derived | Ganesan P, Rajendranath R, Kannan K, Radhakrishnan V, Ganesan TS, Udupa K, Lakshmipathy KM, Mahajan V, Sundersingh S, Rajaraman S, Krishnakumar R, Sagar TG. Phase II study of interim PET-CT-guided response-adapted therapy in advanced Hodgkin's lymphoma. Ann Oncol. 2015 Jun;26(6):1170-1174. doi: 10.1093/annonc/mdv077. Epub 2015 Feb 20. |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |