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

Phase 2

Completed

• Conditions: Leukemia

• Registration Number: NCT00775593
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Timeline

• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-17
• Study First Posted: 2008-10-20
• Study Start: 2008-12
• Primary Completion: 2012-06
• Study Completion: 2013-10-23
• Results First Submitted: 2014-06-10
• Results First Submitted QC: 2015-03-15
• Results First Posted: 2015-03-23
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

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)

Azienda ospedaliera Nuovo ospedale "Torrette"; 🇮🇹 Ancona, Italy

Azienda Ospedaliero-Universitaria Policlinico Consorziale; 🇮🇹 Bari, Italy

Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi; 🇮🇹 Bologna, Italy

Ospedale Ferrarotto; 🇮🇹 Catania, Italy

Ospedale Regionale A. Pugliese; 🇮🇹 Catanzaro, Italy

Azienda ospedaliera di Rilievo Nazionale "A. Cardarelli"; 🇮🇹 Napoli, Italy

Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia; 🇮🇹 Napoli, Italy

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro; 🇮🇹 Novara, Italy

A.O. Universitaria S. Luigi Gonzaga di Orbassano; 🇮🇹 Orbassano, Italy

Azienda Ospedaliero - Universitaria di Parma; 🇮🇹 Parma, Italy

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