Trial Outcomes & Findings for Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL) (NCT NCT01191749)

NCT ID: NCT01191749

Last Updated: 2017-05-09

Results Overview

Overall response (OR) defined as complete/partial remission for at least 4 weeks or hematologic improvement for at least 8 weeks. Response Criteria are according to the Modified IWG Response Criteria in Myelodysplasia. IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (\<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \>= 11 gram per deciliter (g/dL), neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \>=50%, still greater than 5% in bone marrow. Hematologic improvement are measured in participants with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or red blood count (RBC)-transfusion dependence, platelet count \<100 x 10\^9/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 x 10\^9/L.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Up to 6 months following treatment; response assessed every 2 months

Results posted on

2017-05-09

Participant Flow

Recruitment Period: August 27, 2010 to November 22, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Study closed due to slow accrual and change in drug availability.

Participant milestones

Participant milestones
Measure	Alemtuzumab Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alemtuzumab n=7 Participants Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months following treatment; response assessed every 2 months

Population: One subject's response was indeterminate due to the absence of end of therapy assessments.

Outcome measures

Outcome measures
Measure	Alemtuzumab n=6 Participants Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria Complete Remission (CR)	0 participants
Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria Partial Remission (PR)	0 participants
Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria Hematologic Improvement	1 participants
Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria Disease Progression	1 participants
Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria Stable Disease (SD)	4 participants

Adverse Events

Alemtuzumab

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Alemtuzumab n=7 participants at risk Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
Infections and infestations Bacteremia	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.
Infections and infestations Bladder infection	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.
Infections and infestations Febrile Neutropenia	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.
Infections and infestations Septic Shock	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.

Other adverse events

Other adverse events
Measure	Alemtuzumab n=7 participants at risk Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
Renal and urinary disorders Urinary Tract Infection	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.
Skin and subcutaneous tissue disorders Hives	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.
Gastrointestinal disorders Mucositis	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.
Gastrointestinal disorders Nausea and Vomiting	28.6% 2/7 • Number of events 2 • Adverse event collection for 10 day cycle with treatment expected for 3 months.
Cardiac disorders Hypotension	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.
Metabolism and nutrition disorders Elevated ALT	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.
Metabolism and nutrition disorders Elevated AST	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.
General disorders Chills	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.
Nervous system disorders Headache	14.3% 1/7 • Number of events 1 • Adverse event collection for 10 day cycle with treatment expected for 3 months.

Additional Information

Tapan Kadia, MD

University of Texas (UT) MD Anderson Cancer Center

Phone: 1-877-632-6789

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place