Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00775593
- 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 stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving clofarabine together with temsirolimus works in treating older patients with relapsed or refractory acute myeloid leukemia.
- 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
* To determine the tolerability and safety of this regimen.
* To determine the duration of response.
* To determine the duration of survival.
OUTLINE: This is a multicenter study.
* Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and temsirolimus IV over 30 minutes on days 1, 8, and 15. Treatment continues for 1-2 courses in the absence of disease progression or unacceptable toxicity.
* Maintenance therapy: Patients achieving morphologic complete remission (CR) or CR with incomplete blood count recovery receive temsirolimus IV over 30 minutes on days 1 and 8 of each month. Treatment continues for 12 months in the absence of disease progression or unacceptable toxicity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Complete Response Rate At 2 years from study entry
- Secondary Outcome Measures
Name Time Method Duration of Survival At 2 years from study entry Number of Serious Adverse Events Within 2 Years At 2 years from study entry Duration of Response At 2 years from study entry Participants who responded to treatment
Trial Locations
- Locations (19)
Policlinico G. B. Rossi - Borgo Roma
🇮🇹Verona, Italy
Ospedale S. Eugenio
🇮🇹Roma, Italy
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
🇮🇹Roma, Italy
Azienda Ospedaliero-Universitaria Policlinico Consorziale
🇮🇹Bari, Italy
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
🇮🇹Napoli, Italy
A.O. Universitaria S. Luigi Gonzaga di Orbassano
🇮🇹Orbassano, Italy
Azienda ospedaliera Nuovo ospedale "Torrette"
🇮🇹Ancona, Italy
Azienda ospedaliera di Rilievo Nazionale "A. Cardarelli"
🇮🇹Napoli, Italy
Ospedale Regionale A. Pugliese
🇮🇹Catanzaro, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
🇮🇹Novara, Italy
Azienda Ospedaliero - Universitaria di Parma
🇮🇹Parma, Italy
Azienda ASL di Pescara
🇮🇹Pescara, Italy
Complesso Ospedaliero S. Giovanni Addolorata
🇮🇹Roma, Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
🇮🇹Roma, Italy
Policlinico di Tor Vergata
🇮🇹Rome, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
🇮🇹Sassari, Italy
Ospedale Ferrarotto
🇮🇹Catania, Italy