NCT00822120|CompletedPhase 2Results

S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma

A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000630501S0816U10CA032102

Study Type

interventional

Target

371

Locations

1 country

Sites

423

Timeline

RegisteredJan 2009

StartedJul 2009

CompletionJun 2022

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment. PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

371

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline

Completed

Started Jul 2009

Longer than P75 for phase_2 lymphoma

Geographic Reach

1 country

423 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

13 years study duration

First Submitted

Initial submission to the registry

January 13, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed

6 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed

6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

April 4, 2018

Completed

4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed

Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

6.8 years

First QC Date

January 13, 2009

Results QC Date

October 3, 2017

Last Update Submit

August 16, 2022

Conditions

Lymphoma Nonneoplastic Condition

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomaadult lymphocyte depletion Hodgkin lymphomaadult lymphocyte predominant Hodgkin lymphomaadult mixed cellularity Hodgkin lymphomaadult nodular sclerosis Hodgkin lymphomaHIV infection

Outcome Measures

Primary Outcomes (2)

Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
2 years
Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
2 years

Secondary Outcomes (7)

Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging
2 years
Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
7 months after registration
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Up to 1 year
Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
2 years
Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.
5 years
+2 more secondary outcomes

Study Arms (4)

HIV Positive, PET Positive: BEACOPP standard

EXPERIMENTAL

Etoposide 100 mg/m2 IV Days 1, 2, 3 Dox 25 mg/m2 IV Day 1 Cyclo 650mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 Q 21 Days x 6 cycles

Biological: bleomycin sulfateDrug: BEACOPP regimenDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: etoposideDrug: prednisoneDrug: procarbazine hydrochlorideDrug: vincristine sulfate

HIV Negative, PET Positive: BEACOPP escalated

EXPERIMENTAL

Etoposide 200 mg/m2 IV Days 1, 2, 3 Dox 35 mg/m2 IV Day 1 Cyclo 1,250 mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 G-CSF 5mcg/kg/day SQ Days 8-14 Q 21 Days x 6 cycles

Biological: bleomycin sulfateBiological: filgrastimDrug: BEACOPP regimenDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: etoposideDrug: prednisoneDrug: procarbazine hydrochlorideDrug: vincristine sulfate

HIV Positive, PET Negative: ABVD

ACTIVE COMPARATOR

Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2

Biological: bleomycin sulfateDrug: ABVD regimenDrug: dacarbazineDrug: doxorubicin hydrochlorideDrug: vinblastine sulfate

HIV Negative, PET Negative: ABVD

ACTIVE COMPARATOR

Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2

Biological: bleomycin sulfateDrug: ABVD regimenDrug: dacarbazineDrug: doxorubicin hydrochlorideDrug: vinblastine sulfate

Interventions

bleomycin sulfateBIOLOGICAL

HIV Negative, PET Negative: ABVDHIV Negative, PET Positive: BEACOPP escalatedHIV Positive, PET Negative: ABVDHIV Positive, PET Positive: BEACOPP standard

filgrastimBIOLOGICAL

HIV Negative, PET Positive: BEACOPP escalated

ABVD regimenDRUG

HIV Negative, PET Negative: ABVDHIV Positive, PET Negative: ABVD

BEACOPP regimenDRUG