Trial Outcomes & Findings for Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma (NCT NCT01390584)
NCT ID: NCT01390584
Last Updated: 2023-06-29
Results Overview
Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Assessed at 36 months
Results posted on
2023-06-29
Participant Flow
This study was activated on April 2, 2012, accrued its first patient on May 24, 2013, and closed on January 24, 2014 with a final accrual of 6 patients.
Participant milestones
| Measure |
ABVD + INRT
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.
ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
|
ABVD + BEACOPP + INRT
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.
BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
|
Induction ABVD
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
|
|---|---|---|---|
|
Step 1: Induction Tx (ABVD Then PET/CT)
STARTED
|
4
|
1
|
1
|
|
Step 1: Induction Tx (ABVD Then PET/CT)
COMPLETED
|
4
|
1
|
0
|
|
Step 1: Induction Tx (ABVD Then PET/CT)
NOT COMPLETED
|
0
|
0
|
1
|
|
Step 2: ABVD or BEACOPP Then INRT
STARTED
|
4
|
1
|
0
|
|
Step 2: ABVD or BEACOPP Then INRT
COMPLETED
|
4
|
1
|
0
|
|
Step 2: ABVD or BEACOPP Then INRT
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
ABVD + INRT
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.
ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
|
ABVD + BEACOPP + INRT
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.
BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
|
Induction ABVD
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
|
|---|---|---|---|
|
Step 1: Induction Tx (ABVD Then PET/CT)
Ineligible
|
0
|
0
|
1
|
Baseline Characteristics
Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A (ABVD + INRT)
n=4 Participants
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.
ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
|
Arm B (ABVD + BEACOPP + INRT)
n=1 Participants
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.
BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
35 years
n=7 Participants
|
40 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at 36 monthsPopulation: Only eligible and treated patients are included in this analysis
Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
Outcome measures
| Measure |
ABVD + INRT
n=4 Participants
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.
ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
Doxorubicin: IV
Bleomycin: IV
Vinblastine: IV
PET: fludeoxyglucose F 18 Imaging exam
INRT: selective external radiation therapy
Dacarbazine: IV
|
ABVD + BEACOPP + INRT
n=1 Participants
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.
BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
Doxorubicin: IV
Bleomycin: IV
Vinblastine: IV
PET: fludeoxyglucose F 18 Imaging exam
INRT: selective external radiation therapy
Dacarbazine: IV
Etoposide: IV
Cyclophosphamide: May be given orally, IV push, or by IV infusion
Vincristine: IV
Procarbazine: PO
Prednisone: PO
|
|---|---|---|
|
Progression-free Survival Rate
|
NA proportion of participants
The study was terminated early due to slow accrual. At the time of final analysis, none of the patients were followed for 36 months so 36-month progression-free survival rate could not be reported.
|
NA proportion of participants
The study was terminated early due to slow accrual. At the time of final analysis, none of the patients were followed for 36 months so 36-month progression-free survival rate could not be reported.
|
SECONDARY outcome
Timeframe: Assessed at end of Cycle 2Population: Only eligible and treated patients are included in this analysis
Outcome measures
| Measure |
ABVD + INRT
n=5 Participants
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.
ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
Doxorubicin: IV
Bleomycin: IV
Vinblastine: IV
PET: fludeoxyglucose F 18 Imaging exam
INRT: selective external radiation therapy
Dacarbazine: IV
|
ABVD + BEACOPP + INRT
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.
BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
Doxorubicin: IV
Bleomycin: IV
Vinblastine: IV
PET: fludeoxyglucose F 18 Imaging exam
INRT: selective external radiation therapy
Dacarbazine: IV
Etoposide: IV
Cyclophosphamide: May be given orally, IV push, or by IV infusion
Vincristine: IV
Procarbazine: PO
Prednisone: PO
|
|---|---|---|
|
Proportion of Patients Who Are PET Negative After Induction Treatment
|
0.8 proportion of participants
Interval 0.34 to 0.99
|
—
|
SECONDARY outcome
Timeframe: Assessed at 36 monthsPopulation: Only patients who are PET positive are included in this analysis
Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
Outcome measures
| Measure |
ABVD + INRT
n=1 Participants
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.
ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
Doxorubicin: IV
Bleomycin: IV
Vinblastine: IV
PET: fludeoxyglucose F 18 Imaging exam
INRT: selective external radiation therapy
Dacarbazine: IV
|
ABVD + BEACOPP + INRT
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.
BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
Doxorubicin: IV
Bleomycin: IV
Vinblastine: IV
PET: fludeoxyglucose F 18 Imaging exam
INRT: selective external radiation therapy
Dacarbazine: IV
Etoposide: IV
Cyclophosphamide: May be given orally, IV push, or by IV infusion
Vincristine: IV
Procarbazine: PO
Prednisone: PO
|
|---|---|---|
|
Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment
|
NA proportion of participants
The study was terminated early due to slow accrual. At the time of final analysis, none of the patients were followed for 36 months so 36-month progression-free survival rate could not be reported.
|
—
|
SECONDARY outcome
Timeframe: Assessed at end of Cycle 2Population: Only eligible and treated patients are included in this analysis
Complete response (CR) is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy.
Outcome measures
| Measure |
ABVD + INRT
n=5 Participants
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.
ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
Doxorubicin: IV
Bleomycin: IV
Vinblastine: IV
PET: fludeoxyglucose F 18 Imaging exam
INRT: selective external radiation therapy
Dacarbazine: IV
|
ABVD + BEACOPP + INRT
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.
BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
Doxorubicin: IV
Bleomycin: IV
Vinblastine: IV
PET: fludeoxyglucose F 18 Imaging exam
INRT: selective external radiation therapy
Dacarbazine: IV
Etoposide: IV
Cyclophosphamide: May be given orally, IV push, or by IV infusion
Vincristine: IV
Procarbazine: PO
Prednisone: PO
|
|---|---|---|
|
Complete Response (CR) Rate After Induction Treatment
|
1.0 proportion of participants
Interval 0.55 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Assessed at 36 monthsPopulation: Only eligible and treated patients are included in this analysis
Overall survival is defined as the time from study entry to death or date last known alive.
Outcome measures
| Measure |
ABVD + INRT
n=4 Participants
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.
ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
Doxorubicin: IV
Bleomycin: IV
Vinblastine: IV
PET: fludeoxyglucose F 18 Imaging exam
INRT: selective external radiation therapy
Dacarbazine: IV
|
ABVD + BEACOPP + INRT
n=1 Participants
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.
BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
Doxorubicin: IV
Bleomycin: IV
Vinblastine: IV
PET: fludeoxyglucose F 18 Imaging exam
INRT: selective external radiation therapy
Dacarbazine: IV
Etoposide: IV
Cyclophosphamide: May be given orally, IV push, or by IV infusion
Vincristine: IV
Procarbazine: PO
Prednisone: PO
|
|---|---|---|
|
Overall Survival
|
NA months
Median OS was not reached. All patients were alive as of this analysis. The upper and lower limits of the 95% confidence interval were not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
NA months
Median OS was not reached. The patient was alive as of this analysis. The upper and lower limits of the 95% confidence interval were not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: Assessed at 3, 12, 18, 24 and 36 months after INRTPopulation: The study was terminated early due to slow accrual. Relapse data were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and post cycle 2Population: The study was terminated early due to slow accrual. Biomarker data were not collected.
To bank serum and plasma at baseline and follow-up time point to assess the prognostic value of various markers, such as but not limited to, SCD30, IL10, CCL17, CCL22, and MDC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and relapse/progressionPopulation: The study was terminated early due to slow accrual. Biomarker data were not collected.
To create TMAs from patient tumor blocks for future biomarker assessment including but not limited to bcl-2, FOXP3, and macrophage content.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and cycle 2 for TARC assessments; 3 years for PFSPopulation: The study was terminated early due to slow accrual. TARC data were not collected.
To measure serum TARC levels pre-treatment and after two cycles of ABVD and evaluate the associations between TARC levels and PET-CT findings as well as 3-year PFS.
Outcome measures
Outcome data not reported
Adverse Events
Step 1: Induction Treatment
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Step 2: ABVD + INRT
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Step 2: BEACOPP + INRT
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Step 1: Induction Treatment
n=6 participants at risk
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). Patients will be assigned to Step 2 treatments (either ABVD + INRT or BEACOPP + INRT) depending on the scan results (negative or positive).
|
Step 2: ABVD + INRT
n=4 participants at risk
ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
|
Step 2: BEACOPP + INRT
n=1 participants at risk
BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
66.7%
4/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
75.0%
3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Step 1: Induction Treatment
n=6 participants at risk
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). Patients will be assigned to Step 2 treatments (either ABVD + INRT or BEACOPP + INRT) depending on the scan results (negative or positive).
|
Step 2: ABVD + INRT
n=4 participants at risk
ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
|
Step 2: BEACOPP + INRT
n=1 participants at risk
BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
4/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chills
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
66.7%
4/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
4/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
75.0%
3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
2/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Immune system disorders
Allergic reaction
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
75.0%
3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight gain
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
83.3%
5/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
75.0%
3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
1/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
2/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.0%
1/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
75.0%
3/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Superficial thrombophlebitis
|
16.7%
1/6 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/4 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60