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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01304849
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : February 4, 2015
Information provided by (Responsible Party):
Prasanth Ganesan, 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

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: Escalated BEACOPP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Interim PET-CT Scan-guided Response Adapted Therapy in Hodgkin's Lymphoma
Study Start Date : January 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Primary
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.
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

Other Name: EB

Primary Outcome Measures :
  1. Efficacy of interim PET guided therapy strategy interms of EFS in advanced HL [ Time Frame: 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 :
  1. Toxicity of escalated BEACOPP [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01304849

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Department of Medical Oncology, Cancer Institute (WIA), Adyar
Chennai, Tamil Nadu, India, 600020
Sponsors and Collaborators
Cancer Institute WIA
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Principal Investigator: Prasanth Ganesan, MD, DM Cancer Institute (WIA) , Adyar, Chennai

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prasanth Ganesan, Assistant Professor, Cancer Institute WIA Identifier: NCT01304849    
Other Study ID Numbers: CIA-HL-1
First Posted: February 28, 2011    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by Prasanth Ganesan, Cancer Institute WIA:
Hodgkin's Lymphoma
PET CT scan
Escalated BEACOPP
Response adapted therapy
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents