Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML1107)

October 10, 2017 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Azienda ospedaliera Nuovo Ospedale "Torrette"
      • Bari, Italy
        • Azienda Ospedaliero-Universitaria Policlinico Consorziale
      • Bologna, Italy, 40138
        • Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
      • Catania, Italy, 95124
        • Ospedale Ferrarotto
      • Catanzaro, Italy, 88100
        • Ospedale Regionale A. Pugliese
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
      • Napoli, Italy
        • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
      • Novara, Italy
        • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
      • Orbassano, Italy
        • A.O. Universitaria S. Luigi Gonzaga Di Orbassano
      • Parma, Italy
        • Azienda Ospedaliero - Universitaria di Parma
      • Pescara, Italy, 61100
        • Azienda ASL di Pescara
      • Roma, Italy
        • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
      • Roma, 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
      • Rome, Italy, 00168
        • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
      • Rome, Italy, 00133
        • Policlinico di Tor Vergata
      • Sassari, Italy
        • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
      • Verona, Italy, 37134
        • Policlinico G. B. Rossi - Borgo Roma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete Response Rate
Time Frame: At 2 years from study entry
At 2 years from study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Serious Adverse Events Within 2 Years
Time Frame: At 2 years from study entry
At 2 years from study entry
Duration of Response
Time Frame: At 2 years from study entry
Participants who responded to treatment
At 2 years from study entry
Duration of Survival
Time Frame: At 2 years from study entry
At 2 years from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Sergio Amadori, MD, Ospedale Sant' Eugenio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

October 23, 2013

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Actual)

November 9, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AML1107
  • GIMEMA-AML-1107
  • EUDRACT-2007-005374-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia

Clinical Trials on clofarabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe