Trial Outcomes & Findings for Combination Chemotherapy With or Without Bortezomib in Treating Patients With Classical Hodgkin Lymphoma That Has Returned or Does Not Respond to Prior Treatment. (NCT NCT00967369)

Last Updated: 2020-04-20

Results Overview

Response rates for Bortezomib, Ifosfamide, Carboplatin, Etoposide (BICE) and Ifosfamide, Carboplatin, Etoposide (ICE) treatment groups were assessed by the 1999 International Working Group (IWG)(CT alone) (Cheson et al., 1999) and compared to 2007 IWG (CT plus PET) (Cheson et al., 2007) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

From baseline to 3 cycles of treatment

Results posted on

2020-04-20

Participant Flow

Recruitment Period: August 2009 to August 2011 at MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide) Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.	ICE (Ifosfamide, Carboplatin, Etoposide) Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
Overall Study STARTED	10	10
Overall Study Relapsed	4	7
Overall Study Refractory	6	3
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Chemotherapy With or Without Bortezomib in Treating Patients With Classical Hodgkin Lymphoma That Has Returned or Does Not Respond to Prior Treatment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide) n=10 Participants Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.	ICE (Ifosfamide, Carboplatin, Etoposide) n=10 Participants Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	1 Participants n=7 Participants	1 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	7 Participants n=7 Participants	15 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Mexico	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients with Rela Mobilization regimens:Ifosfamide +etoposide	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients with Rela Mobilization regimen:Gemcitabine,Navelbine,Doxorub	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients with Rela Mobilization regimen:Cyclophosphamide	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients with Rela SD by CT imaging, but given PET negativity, receiv	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients with Rela Conditioning regimen Gemcitabine/Busulfan/melphala	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients with Rela Conditioning regimen BEAM followed with ASCT	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 3 cycles of treatment

Outcome measures

Outcome measures
Measure	BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide) n=10 Participants Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.	ICE (Ifosfamide, Carboplatin, Etoposide) n=10 Participants Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
Overall Response After 3 Cycles of Botezomib Plus ICE (BICE) Versus Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Overall Response	7 Participants	6 Participants
Overall Response After 3 Cycles of Botezomib Plus ICE (BICE) Versus Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Complete Response (CR)	3 Participants	1 Participants
Overall Response After 3 Cycles of Botezomib Plus ICE (BICE) Versus Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Partial Response (PR)	4 Participants	5 Participants
Overall Response After 3 Cycles of Botezomib Plus ICE (BICE) Versus Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Progressive Disease (PD)	0 Participants	0 Participants
Overall Response After 3 Cycles of Botezomib Plus ICE (BICE) Versus Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Stable Disease (SD)	1 Participants	3 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Progression free survival time is defined as the time interval from treatment start to progression or death due to any cause whichever happens first. Participants will be censored at the last follow-up date, if an event(progression/death) is not observed during the follow-up.

Outcome measures

Outcome measures
Measure	BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide) n=10 Participants Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.	ICE (Ifosfamide, Carboplatin, Etoposide) n=10 Participants Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
Progression Free Survival (PFS) Rate at 12 Months	50 percentage of participants	70 percentage of participants

PRIMARY outcome

Timeframe: 24 months

Overall Survival is time from date of treatment start until date of death due to any cause or last Follow-up within 24 months.

Outcome measures

Outcome measures
Measure	BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide) n=10 Participants Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.	ICE (Ifosfamide, Carboplatin, Etoposide) n=10 Participants Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
Overall Survival (OS) Rate at 24 Months	70 percentage of participants	89 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to 1 year

Response rates for BICE and ICE treatment groups will be assessed by 1999 IWG (CT alone) (Cheson et al., 1999) and compared to 2007 IWG (CT plus PET) (Cheson et al., 2007) criteria.

Outcome measures

Outcome measures
Measure	BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide) n=10 Participants Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.	ICE (Ifosfamide, Carboplatin, Etoposide) n=10 Participants Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
PET Scan Response After 3 Cycles of BICE Versus ICE Chemotherapy. PET negativity : Complete Response (CR)	3 Participants	6 Participants
PET Scan Response After 3 Cycles of BICE Versus ICE Chemotherapy. PET negativity : Partial Response (PR)	0 Participants	4 Participants
PET Scan Response After 3 Cycles of BICE Versus ICE Chemotherapy. PET negativity : Stable Disease (SD)	0 Participants	1 Participants
PET Scan Response After 3 Cycles of BICE Versus ICE Chemotherapy. PET positivity : Partial Response (PR)	4 Participants	2 Participants
PET Scan Response After 3 Cycles of BICE Versus ICE Chemotherapy. PET positivity : Stable Disease (SD)	1 Participants	2 Participants
PET Scan Response After 3 Cycles of BICE Versus ICE Chemotherapy. PET positivity : Progressive Disease (PD)	2 Participants	0 Participants

SECONDARY outcome

Timeframe: November 2009 and December 2010

Population: Incomplete report as study was stopped early due to futility

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 106 weeks/13 months/426 days

Population: Incomplete report as study was stopped early due to futility. Participant with relapsed/refractory HL prior to autologous transplant

Outcome measures

Outcome data not reported

Adverse Events

BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

ICE (Ifosfamide, Carboplatin, Etoposide)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide) n=10 participants at risk Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.	ICE (Ifosfamide, Carboplatin, Etoposide) n=10 participants at risk Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
Blood and lymphatic system disorders Febrile neutropenia	10.0% 1/10 • 2 years	10.0% 1/10 • 2 years

Other adverse events

Other adverse events
Measure	BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide) n=10 participants at risk Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.	ICE (Ifosfamide, Carboplatin, Etoposide) n=10 participants at risk Relapsed/refractory classical Hodgkin lymphoma who have received a front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
Investigations Neutrophil count decreased	70.0% 7/10 • 2 years	50.0% 5/10 • 2 years
Investigations Platelet count decreased	70.0% 7/10 • 2 years	50.0% 5/10 • 2 years
Investigations Transaminitis	80.0% 8/10 • 2 years	50.0% 5/10 • 2 years
Investigations Hyperbilirubinemia	10.0% 1/10 • 2 years	0.00% 0/10 • 2 years
Nervous system disorders Peripheral sensory neuropathy	10.0% 1/10 • 2 years	0.00% 0/10 • 2 years

Additional Information

Dr. Michelle A Fanale / Associate Professor, Lymphoma/Myeloma

UT MD Anderson Cancer Center

Phone: 713-792-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place