Status:
COMPLETED
Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may s...
Detailed Description
OBJECTIVES: Primary * To determine the complete response rate in older patients with relapsed or refractory acute myeloid leukemia when treated with low-dose clofarabine and temsirolimus. Secondary...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria:
- At least 20% of blasts in the bone marrow
- AML in first relapse OR refractory to no more than one prior combination of intensive chemotherapy induction regimen
- No acute promyelocytic leukemia
- No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
- No active CNS leukemia
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 4 weeks
- Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)\*
- AST and ALT ≤ 2.5 times ULN\*
- Serum creatinine ≤ 1.0 mg/dL\* OR estimated glomerular filtration rate \> 60 mL/min
- No active uncontrolled systemic infection
- No concurrent active malignancy
- No HIV positivity
- No severe concurrent medical condition or psychiatric disorder that would preclude study participation NOTE: \*Unless due to organ leukemic involvement
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 weeks since prior myelosuppressive chemotherapy
- At least 48 hours since prior hydroxyurea
- No prior clofarabine or temsirolimus
- No prior allogeneic stem cell transplantation
- No investigational drug within the past 30 days
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00775593
Start Date
December 1 2008
End Date
October 23 2013
Last Update
November 9 2017
Active Locations (19)
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1
Azienda ospedaliera Nuovo ospedale "Torrette"
Ancona, Italy
2
Azienda Ospedaliero-Universitaria Policlinico Consorziale
Bari, Italy
3
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
Bologna, Italy, 40138
4
Ospedale Ferrarotto
Catania, Italy, 95124