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

Leukemia Clinical Trial

— AML1107  

Official title:

An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775593
• Other study ID #: AML1107
• Secondary ID: GIMEMA-AML-1107E
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2008
• Last updated: October 10, 2017
• Start date: December 2008
• Est. completion date: October 23, 2013

Study information

• Verified date: October 2017
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 23, 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• clofarabine
Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Induction therapy - Clofarabine 20 mg/m2/day, administered by iv infusion over 1 hour on days 1 through 5
• temsirolimus
Those who achieve morphologic CR and morphologic CRi will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a PR will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Induction therapy: - Temsirolimus 25 mg (flat dose) administered iv over 30 minutes on days 1, 8 and 15. Maintenance therapy: - Temsirolimus 25 mg (flat dose) administered iv over 30 minutes on days 1 and 8 of each month for 12 months, or until relapse.

Locations

Country	Name	City	State
Italy	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	Azienda ASL di Pescara	Pescara
Italy	Complesso Ospedaliero S. Giovanni Addolorata	Roma
Italy	Ospedale S. Eugenio	Roma
Italy	S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena	Roma
Italy	Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia	Roma
Italy	Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore	Rome
Italy	Policlinico di Tor Vergata	Rome
Italy	Serv. di Ematologia Ist. di Ematologia ed Endocrinologia	Sassari
Italy	Policlinico G. B. Rossi - Borgo Roma	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate		At 2 years from study entry
Secondary	Number of Serious Adverse Events Within 2 Years		At 2 years from study entry
Secondary	Duration of Response	Participants who responded to treatment	At 2 years from study entry
Secondary	Duration of Survival		At 2 years from study entry