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

Primary Purpose

Hodgkin's Lymphoma

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Escalated BEACOPP

About this trial

This is an interventional treatment trial for Hodgkin's Lymphoma focused on measuring Hodgkin's Lymphoma, PET CT scan, Escalated BEACOPP, ABVD, Response adapted therapy

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicity of escalated BEACOPP

Full Information

NCT ID

NCT01304849

First Posted

February 25, 2011

Last Updated

February 2, 2015

Sponsor

Cancer Institute WIA

1. Study Identification

Unique Protocol Identification Number

NCT01304849

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cancer Institute WIA

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin's Lymphoma

Keywords

Hodgkin's Lymphoma, PET CT scan, Escalated BEACOPP, ABVD, Response adapted therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Primary

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Escalated BEACOPP

Other Intervention Name(s)

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficacy of interim PET guided therapy strategy interms of EFS in advanced HL

Description

Time Frame

Once in a year

Secondary Outcome Measure Information:

Title

Toxicity of escalated BEACOPP

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prasanth Ganesan, MD, DM

Organizational Affiliation

Cancer Institute (WIA) , Adyar, Chennai

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600020

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

25701453

Citation

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.

Results Reference

derived

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

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