Trial Outcomes & Findings for Alemtuzumab + Rituximab Consolidation in CLL (NCT NCT00771602)

Results Overview

Molecular Remissions (minimal residual disease (MRD) flow cytometry-negative) after monoclonal antibody consolidation therapy. Molecular remission is defined as resolution of all detectable disease below the limits of the MRD flow cytometry assay sensitivity.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

52 weeks

Results posted on

2015-06-23

Participant Flow

Recruitment Period: 08/13/08 through 01/26/10. All participants recruited at UT MD Anderson Cancer Center.

Study was closed early as result of low accrual.

Participant milestones

Participant milestones
Measure	Rituximab Group 1: 375 mg/m\^2 intravenous (IV) Rituximab Alone	Alemtuzumab Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone	Rituximab + Alemtuzumab Group 3: 375 mg/m\^2 Rituximab + 30 mg SQ Alemtuzumab
Overall Study STARTED	1	0	0
Overall Study COMPLETED	1	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alemtuzumab + Rituximab Consolidation in CLL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab n=1 Participants Group 1: 375 mg/m\^2 intravenous (IV) Rituximab Alone	Alemtuzumab Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone	Rituximab + Alemtuzumab Group 3: 375 mg/m\^2 Rituximab + 30 mg SQ Alemtuzumab	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 years n=99 Participants	—	—	0 years n=7 Participants
Age, Categorical Between 18 and 65 years	1 years n=99 Participants	—	—	1 years n=7 Participants
Age, Categorical >=65 years	0 years n=99 Participants	—	—	0 years n=7 Participants
Gender Female	0 participants n=99 Participants	—	—	0 participants n=7 Participants
Gender Male	1 participants n=99 Participants	—	—	1 participants n=7 Participants
Region of Enrollment United States	1 participants n=99 Participants	—	—	1 participants n=7 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: No analysis available participant ineligible for evaluation; study terminated due to slow accrual.

Molecular Remissions (minimal residual disease (MRD) flow cytometry-negative) after monoclonal antibody consolidation therapy. Molecular remission is defined as resolution of all detectable disease below the limits of the MRD flow cytometry assay sensitivity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 52 weeks or until disease progression

Progression-free survival (PFS) is measured from date of trial entry until documented progression of disease or death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 52 weeks

The definition of toxicities include any \>/= grade 3 non-hematologic toxicity, \>/= grade 3 infection, and any symptomatic (i.e. febrile) documented CMV (cytomegalovirus) reactivation, according to NCI-WG definitions.

Outcome measures

Outcome data not reported

Adverse Events

Rituximab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Alemtuzumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rituximab + Alemtuzumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rituximab n=1 participants at risk Group 1: 375 mg/m\^2 intravenous (IV) Rituximab Alone	Alemtuzumab Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone	Rituximab + Alemtuzumab Group 3: 375 mg/m\^2 Rituximab + 30 mg SQ Alemtuzumab
General disorders Fever, Low Grade	100.0% 1/1 • Adverse event collection during total treatment duration of 12 weeks; Overall study period: August 13, 2008 to January 26, 2010.	— 0/0 • Adverse event collection during total treatment duration of 12 weeks; Overall study period: August 13, 2008 to January 26, 2010.	— 0/0 • Adverse event collection during total treatment duration of 12 weeks; Overall study period: August 13, 2008 to January 26, 2010.
Gastrointestinal disorders Nausea	100.0% 1/1 • Adverse event collection during total treatment duration of 12 weeks; Overall study period: August 13, 2008 to January 26, 2010.	— 0/0 • Adverse event collection during total treatment duration of 12 weeks; Overall study period: August 13, 2008 to January 26, 2010.	— 0/0 • Adverse event collection during total treatment duration of 12 weeks; Overall study period: August 13, 2008 to January 26, 2010.

Additional Information

Stefan Faderl, MD / Professor

UT MD Anderson Cancer Center

Phone: 713-745-4613

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place