Trial Outcomes & Findings for Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT00775593)

NCT ID: NCT00775593

Last Updated: 2017-11-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: At 2 years from study entry
• Results posted on: 2017-11-09

Participant Flow

Between April 2009 and June 2010, 60 patients were enrolled in the study at 14 different Italian institutions.

Participant milestones

Measure	Study Group Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
Overall Study STARTED	60
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Study Group Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
Overall Study Unmet eligibility criteria	6
Overall Study Death	1

Baseline Characteristics

Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia

Baseline characteristics by cohort

Measure	Study Group n=53 Participants Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
Age, Customized	69 Years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment Italy	53 participants n=5 Participants

PRIMARY outcome

Timeframe: At 2 years from study entry

Outcome measures

Measure	Study Group n=53 Participants Evaluable patients
Complete Response Rate	4 participants

SECONDARY outcome

Timeframe: At 2 years from study entry

Outcome measures

Measure	Study Group n=53 Participants Evaluable patients
Number of Serious Adverse Events Within 2 Years	22 serious adverse events

SECONDARY outcome

Timeframe: At 2 years from study entry

Participants who responded to treatment

Outcome measures

Measure	Study Group n=11 Participants Evaluable patients
Duration of Response	3.5 months Standard Deviation 12

SECONDARY outcome

Timeframe: At 2 years from study entry

Outcome measures

Measure	Study Group n=53 Participants Evaluable patients
Duration of Survival	10.9 months Interval 0.3 to 20.2

Adverse Events

Study Group

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Study Group n=53 participants at risk Evaluable patients
Cardiac disorders Cardiac arrest	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Gastrointestinal disorders Gastrointestinal mucositis	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Gastrointestinal disorders Melaena	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
General disorders Disease Progression	7.5% 4/53 • Number of events 4 Non-serious adverse events have not been analyzed
General disorders Mucosal inflammation	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Infections and infestations E. coli sepsis	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Infections and infestations Pseudomonal sepsis	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Infections and infestations Septic shock	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Infections and infestations Sepsis	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Infections and infestations Pneumonia	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Nervous system disorders Cerebral ischemia	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Nervous system disorders Neuropathy	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Nervous system disorders Convulsion	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Nervous system disorders Optic ischaemic neuropathy	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Renal and urinary disorders Acute renal failure	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.9% 1/53 • Number of events 1 Non-serious adverse events have not been analyzed
Respiratory, thoracic and mediastinal disorders Pneumonia	3.8% 2/53 • Number of events 2 Non-serious adverse events have not been analyzed

Other adverse events

Adverse event data not reported

Additional Information

Edoardo La Sala

GIMEMA

Phone: +39 06 70390524

Email: e.lasala@gimema.it

Results disclosure agreements

• Principal investigator is a sponsor employee Results are analyzed together with the sponsor, being the present study a fully independent not-for-profit trial.
• Publication restrictions are in place

Restriction type: OTHER