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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00775593
First received: October 17, 2008
Last updated: November 4, 2013
Last verified: November 2013

October 17, 2008
November 4, 2013
December 2008
June 2012   (final data collection date for primary outcome measure)
Complete response rate [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
Complete response rate [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00775593 on ClinicalTrials.gov Archive Site
  • Tolerability and safety [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
  • Duration of survival [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
  • Tolerability and safety [ Designated as safety issue: Yes ]
  • Duration of response [ Designated as safety issue: No ]
  • Duration of survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia
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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • 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

  • Drug: 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.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2012
June 2012   (final data collection date for primary outcome measure)

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 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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00775593
AML1107, GIMEMA-AML-1107, EUDRACT-2007-005374-31, EU-20886, WYETH-GIMEMA-AML-1107
No
Gruppo Italiano Malattie EMatologiche dell'Adulto
Gruppo Italiano Malattie EMatologiche dell'Adulto
Not Provided
Principal Investigator: Sergio Amadori, MD Ospedale Sant' Eugenio
Gruppo Italiano Malattie EMatologiche dell'Adulto
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP