Trial Outcomes & Findings for Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome (NCT NCT00360672)

NCT ID: NCT00360672

Last Updated: 2013-08-14

Results Overview

Response for Acute Myeloid Leukemia (AML) according to 2003 International Working Group (IWG) criteria: CR required absolute neutrophil count (ANC) \>1 \* 10\^9/L, platelet count ≥100 \* 10\^9/L, \< 5% of blast cells in bone marrow. CRp: as above except platelet count \<100 \* 10\^9/L. Partial remission: as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%. Response for Myelodysplastic Syndrome (MDS) was defined based on the 2006 IWG criteria. All participants with MDS who achieved hematological CR, Partial Response (PR), marrow CR, and hematological improvement considered responders.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: Following three 28-day cycles evaluated for response
• Results posted on: 2013-08-14

Participant Flow

Recruitment Period: 08/03/2006 through 05/10/2012. All participants recruited at UT MD Anderson Cancer Center.

Participant milestones

Measure	Revlimid Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome

Baseline characteristics by cohort

Measure	Revlimid n=27 Participants Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
Age Continuous	64 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Following three 28-day cycles evaluated for response

Response for Acute Myeloid Leukemia (AML) according to 2003 International Working Group (IWG) criteria: CR required absolute neutrophil count (ANC) >1 * 10^9/L, platelet count ≥100 * 10^9/L, < 5% of blast cells in bone marrow. CRp: as above except platelet count <100 * 10^9/L. Partial remission: as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%. Response for Myelodysplastic Syndrome (MDS) was defined based on the 2006 IWG criteria. All participants with MDS who achieved hematological CR, Partial Response (PR), marrow CR, and hematological improvement considered responders.

Outcome measures

Measure	Revlimid n=27 Participants Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
Number of Participants With a Response (Complete Remissions (CR), Complete Remissions With Incomplete Platelet Recovery [CRp] and Partial Responses) Complete Remission	1 participants
Number of Participants With a Response (Complete Remissions (CR), Complete Remissions With Incomplete Platelet Recovery [CRp] and Partial Responses) Complete Remission Incomplete Platelet Recovery	1 participants
Number of Participants With a Response (Complete Remissions (CR), Complete Remissions With Incomplete Platelet Recovery [CRp] and Partial Responses) Partial Remission	0 participants

Adverse Events

Revlimid

Serious events: 9 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Revlimid n=27 participants at risk Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
Infections and infestations Infection	11.1% 3/27 • Number of events 3 • 5 years, 8 months
Gastrointestinal disorders Vomit	3.7% 1/27 • Number of events 1 • 5 years, 8 months
Gastrointestinal disorders Hemorrhage	3.7% 1/27 • Number of events 1 • 5 years, 8 months
Nervous system disorders Stroke	7.4% 2/27 • Number of events 3 • 5 years, 8 months
General disorders Death	18.5% 5/27 • Number of events 5 • 5 years, 8 months
Renal and urinary disorders Renal Failure	3.7% 1/27 • Number of events 1 • 5 years, 8 months
Cardiac disorders Atrial Fibrillation	11.1% 3/27 • Number of events 6 • 5 years, 8 months

Other adverse events

Measure	Revlimid n=27 participants at risk Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
Blood and lymphatic system disorders Neutropenia	29.6% 8/27 • Number of events 8 • 5 years, 8 months
Blood and lymphatic system disorders Thrombocytopenia	51.9% 14/27 • Number of events 14 • 5 years, 8 months
Infections and infestations Neutropenic Fever	14.8% 4/27 • Number of events 4 • 5 years, 8 months
Infections and infestations Neutropenic Fever With Pneumonia	11.1% 3/27 • Number of events 3 • 5 years, 8 months
Infections and infestations Nonneutropenic Infection	48.1% 13/27 • Number of events 13 • 5 years, 8 months
General disorders Fatigue	11.1% 3/27 • Number of events 3 • 5 years, 8 months

Additional Information

Gautam Borthakur, M.D./Associate Professor

UT MD Anderson Cancer Center

Phone: 713-563-1586

Email: eharriso@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place