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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
clofarabine
temsirolimus
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with inv(16)(p13;q22)

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda ospedaliera Nuovo ospedale "Torrette"
  • Azienda Ospedaliero-Universitaria Policlinico Consorziale
  • Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
  • Ospedale Ferrarotto
  • Ospedale Regionale A. Pugliese
  • Azienda ospedaliera di Rilievo Nazionale "A. Cardarelli"
  • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
  • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
  • A.O. Universitaria S. Luigi Gonzaga di Orbassano
  • Azienda Ospedaliero - Universitaria di Parma
  • Azienda ASL di Pescara
  • Complesso Ospedaliero S. Giovanni Addolorata
  • Ospedale S. Eugenio
  • S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
  • Policlinico di Tor Vergata
  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
  • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
  • Policlinico G. B. Rossi - Borgo Roma

Outcomes

Primary Outcome Measures

Complete Response Rate

Secondary Outcome Measures

Number of Serious Adverse Events Within 2 Years
Duration of Response
Participants who responded to treatment
Duration of Survival

Full Information

First Posted
October 17, 2008
Last Updated
October 10, 2017
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT00775593
Brief Title
Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia
Acronym
AML1107
Official Title
An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 23, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent adult acute myeloid leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with inv(16)(p13;q22)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
clofarabine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
temsirolimus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete Response Rate
Time Frame
At 2 years from study entry
Secondary Outcome Measure Information:
Title
Number of Serious Adverse Events Within 2 Years
Time Frame
At 2 years from study entry
Title
Duration of Response
Description
Participants who responded to treatment
Time Frame
At 2 years from study entry
Title
Duration of Survival
Time Frame
At 2 years from study entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Amadori, MD
Organizational Affiliation
Ospedale Sant' Eugenio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda ospedaliera Nuovo ospedale "Torrette"
City
Ancona
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Consorziale
City
Bari
Country
Italy
Facility Name
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Ferrarotto
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Ospedale Regionale A. Pugliese
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Azienda ospedaliera di Rilievo Nazionale "A. Cardarelli"
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
City
Napoli
Country
Italy
Facility Name
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
City
Novara
Country
Italy
Facility Name
A.O. Universitaria S. Luigi Gonzaga di Orbassano
City
Orbassano
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria di Parma
City
Parma
Country
Italy
Facility Name
Azienda ASL di Pescara
City
Pescara
ZIP/Postal Code
61100
Country
Italy
Facility Name
Complesso Ospedaliero S. Giovanni Addolorata
City
Roma
Country
Italy
Facility Name
Ospedale S. Eugenio
City
Roma
Country
Italy
Facility Name
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
City
Roma
Country
Italy
Facility Name
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
City
Roma
Country
Italy
Facility Name
Policlinico di Tor Vergata
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
City
Sassari
Country
Italy
Facility Name
Policlinico G. B. Rossi - Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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