Trial Outcomes & Findings for Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia (NCT NCT00462332)

Results Overview

* Normal clinical or X-ray examination (lymph nodes, liver, spleen) * No symptoms * Lymphocytes higher or equal to 4.0 per 10\^9/L * Neutrophils lower or equal to 1.5 per 10\^9/L * Platelets \>100 per 10\^9/L * Hb \>11.0 g/dL * Bone marrow lymphs according to age, lymphocytes \<30%, no nodules.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

At 2 years from study entry

Results posted on

2013-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	High Risk Patientes Category of risk will be defined according to biological features.	Low Risk Patients Category of risk will be defined according to biological features.
Overall Study STARTED	45	41
Overall Study COMPLETED	45	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Risk Patientes n=45 Participants Category of risk will be defined according to biological features.	Low Risk Patients n=41 Participants Category of risk will be defined according to biological features.	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=93 Participants	41 Participants n=4 Participants	86 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	53.02 years STANDARD_DEVIATION 6.09 • n=93 Participants	52.73 years STANDARD_DEVIATION 6.24 • n=4 Participants	53.02 years STANDARD_DEVIATION 6.13 • n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	13 Participants n=4 Participants	24 Participants n=27 Participants
Sex: Female, Male Male	34 Participants n=93 Participants	28 Participants n=4 Participants	62 Participants n=27 Participants
Region of Enrollment Italy	45 participants n=93 Participants	41 participants n=4 Participants	86 participants n=27 Participants

PRIMARY outcome

Timeframe: At 2 years from study entry

* Normal clinical or X-ray examination (lymph nodes, liver, spleen) * No symptoms * Lymphocytes higher or equal to 4.0 per 10\^9/L * Neutrophils lower or equal to 1.5 per 10\^9/L * Platelets \>100 per 10\^9/L * Hb \>11.0 g/dL * Bone marrow lymphs according to age, lymphocytes \<30%, no nodules.

Outcome measures

Outcome measures
Measure	Low Risk Patients n=41 Participants	High Risk Patients n=45 Participants
Number of Patients With Complete Response	14 participants	3 participants

SECONDARY outcome

Timeframe: At 2 years from study entry

Number of AEs and SAEs

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 2 years and a half from study entry

Outcome measures

Outcome measures
Measure	Low Risk Patients n=45 Participants	High Risk Patients n=41 Participants
Length of Survival	1.57 years Standard Deviation 10	1.1 years Standard Deviation 10

SECONDARY outcome

Timeframe: At 2 years from study entry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 2 years from study entry

Outcome measures

Outcome data not reported

Adverse Events

High Risk Patientes

Serious events: 7 serious events

Other events: 32 other events

Deaths: 0 deaths

Low Risk Patients

Serious events: 9 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High Risk Patientes n=45 participants at risk Category of risk will be defined according to biological features.	Low Risk Patients n=41 participants at risk Category of risk will be defined according to biological features.
Blood and lymphatic system disorders Grade >=3 hematologic toxicity	15.6% 7/45 • Number of events 8	22.0% 9/41 • Number of events 10

Other adverse events

Other adverse events
Measure	High Risk Patientes n=45 participants at risk Category of risk will be defined according to biological features.	Low Risk Patients n=41 participants at risk Category of risk will be defined according to biological features.
Blood and lymphatic system disorders AEs related to Campath infusion	28.9% 13/45 • Number of events 77	0.00% 0/41
Blood and lymphatic system disorders Infections	28.9% 13/45 • Number of events 33	29.3% 12/41 • Number of events 20
Blood and lymphatic system disorders Hematologic Toxicity (Grade >=3)	40.0% 18/45 • Number of events 39	61.0% 25/41 • Number of events 71

Additional Information

Alfonso Piciocchi

GIMEMA Foundation Data Center

Phone: +39 06 70390513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place