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Completed

NCT Number: NCT00775593

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

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.

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Key information

Conditions

Leukemia Bone Marrow Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Basophilic, Acute Leukemia, Eosinophilic, Acute Leukemia, Erythroblastic, Acute Leukemia, Megakaryoblastic, Acute Leukemia, Monocytic, Acute Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Azienda ospedaliera Nuovo ospedale "Torrette", Ancona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clofarabine

Drug

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

Drug

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 outcomes

  1. Complete Response Rate

    Time frame: At 2 years from study entry

Secondary outcomes

  1. Number of Serious Adverse Events Within 2 Years

    Time frame: At 2 years from study entry

  2. Duration of Response

    Time frame: At 2 years from study entry

    Participants who responded to treatment

  3. Duration of Survival

    Time frame: At 2 years from study entry

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

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

Acronym: AML1107

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Oct 20, 2008
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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