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AzTrials

LeukemiaPhase 2AML1107NCT00775593

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

A Phase 2 study testing clofarabine and temsirolimus in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 19 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Leukemia
What is being tested?
clofarabine and temsirolimus
Type of treatment
Injection or infusion
How many people
60 participants
Where
19 sitesItaly
Study dates
Dec 2008to 23 Oct 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Italy19 sites

  • Azienda ospedaliera Nuovo ospedale "Torrette"

    Ancona

  • Azienda Ospedaliero-Universitaria Policlinico Consorziale

    Bari

  • Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi

    Bologna, 40138

  • Ospedale Ferrarotto

    Catania, 95124

  • Ospedale Regionale A. Pugliese

    Catanzaro, 88100

  • Azienda ospedaliera di Rilievo Nazionale "A. Cardarelli"

    Naples

  • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

    Naples

  • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

    Novara

  • A.O. Universitaria S. Luigi Gonzaga di Orbassano

    Orbassano

  • Azienda Ospedaliero - Universitaria di Parma

    Parma

  • Azienda ASL di Pescara

    Pescara, 61100

  • Complesso Ospedaliero S. Giovanni Addolorata

    Roma

  • Ospedale S. Eugenio

    Roma

  • S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena

    Roma

  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

    Roma

  • Policlinico di Tor Vergata

    Rome, 00133

  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

    Rome, 00168

  • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

    Sassari

  • Policlinico G. B. Rossi - Borgo Roma

    Verona, 37134

Other trials in Italy

About this study

Official title: 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.

Read the 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.
Conditions
Leukemia
Being tested
clofarabine, temsirolimus
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)
Medical subject headings
Leukemia, Leukemia, Myeloid, Acute, Leukemia, Basophilic, Acute, Leukemia, Eosinophilic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myelomonocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clofarabineDrug

    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

  • temsirolimusDrug

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Rate

    Measured: At 2 years from study entry

Secondary outcomes (3)

  1. Number of Serious Adverse Events Within 2 Years

    Measured: At 2 years from study entry

  2. Duration of Response

    Participants who responded to treatment

    Measured: At 2 years from study entry

  3. Duration of Survival

    Measured: At 2 years from study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionJun 2012
  4. Study completion23 Oct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00775593
Sponsor's protocol ID
AML1107
Other IDs
GIMEMA-AML-1107, EUDRACT-2007-005374-31
Acronym
AML1107
Status last verified
Oct 2017
First submitted
17 Oct 2008
Last updated
9 Nov 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing clofarabine and temsirolimus in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 19 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate (time frame: At 2 years from study entry). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00775593.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.

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