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

Not Applicable

Completed

• Conditions: Hodgkin's Lymphoma
• Interventions: Drug: Escalated BEACOPP

• Registration Number: NCT01304849
• Lead Sponsor: Cancer Institute WIA

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age 12-65 years old
• Newly diagnosed histology proven patients of advanced HL (stage IIb, III and IV)
• Patients' performance status ECOG 0-2
• Normal hematopoetic parameters except if due to marrow involvement by disease (WBC > 4000/cmm, Platelet count > 100,000/cmm)
• No uncontrolled hepatitis B/C infection; and normal LFT values with s -Bilirubin, SGOT and SGPT not more than 2.5 times upper limit of normal (unless initially due to liver involvement by disease)
• Serum Creatinine ≤ 2mg/dL unless elevated due to involvement by disease
• Cardiovascular/ Metabolic: No severe cardiac disease that would limit normal life expectancy or preclude study. LVEF at least 50%; Controlled blood glucose if diabetic; controlled Blood pressure if hypertensive
• Pulmonary: No severe pulmonary disease that would limit normal life expectancy or preclude study
• Others: HIV negative status; No prior haematological cancers or chemotherapy or radiation therapy in the past

Exclusion Criteria

• Pregnancy
• Nursing mothers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary	Escalated BEACOPP	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of interim PET guided therapy strategy interms of EFS in advanced HL	Once in a year	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

Secondary Outcome Measures

Name	Time	Method
Toxicity of escalated BEACOPP	6 months

Trial Locations

Locations (1)

Department of Medical Oncology, Cancer Institute (WIA), Adyar; 🇮🇳 Chennai, Tamil Nadu, India