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

NCT ID: NCT01304849

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-09-30

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

Conditions

Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Escalated BEACOPP

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

EB

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute WIA

OTHER

Sponsor Role: lead

Responsible Party

Prasanth Ganesan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prasanth Ganesan, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute (WIA) , Adyar, Chennai

Locations

Department of Medical Oncology, Cancer Institute (WIA), Adyar

Chennai, Tamil Nadu, India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 25701453 (View on PubMed)

Other Identifiers

CIA-HL-1

Identifier Type: -

Identifier Source: org_study_id