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Acute Myelogenous LeukemiaPhase 2NCT01193400

Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy in AML Patients Age Greater Than or Equal to 60 Years

A Phase 2 study testing Clofarabine and Cytarabine in people with Acute Myelogenous Leukemia, run by PETHEMA Foundation at 15 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Primary outcome measure: Evaluate the efficacy in terms of complete responses of induction therapy and first-line consolidation of Clofarabine and low-dose Cytarabine with AML patients aged 60 years or more. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Acute Myelogenous Leukemia
What is being tested?
Clofarabine and Cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
15 sitesSpain
Study dates
Sep 2010to Feb 2012
Phase
Phase 2
Are there results?
None posted in the registry

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

Who may be able to join

  • Diagnosis of AML (de novo, secondary, or hematological disorder), according to WHO criteria.
  • Older than or equal to 60 years
  • ECOG performance status 0-2
  • At least one of the following factors:
  • Older than or equal to 70 years
  • Prior hematological disorder (AHD)
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  • ECOG performance status 2
  • Unfavorable karyotype (ie, adverse) defined as any cytogenetic profile except the presence of any of the following:
  • t(8;21)(q22;q22) inv(16)(p13q22) or t(16;16)(p13;q22) t(15;17)(q22;q12) and variants
  • Provide written informed consent form.
  • Being able to comply with study procedures and follow-up evaluations.
  • Not to be fertile or willing to use a method of birth control during the study until the end of the last visit of the treatment.
  • Adequate renal and hepatic function as follows:
  • Total bilirubin <= 1,5 x upper of institutional normal limit (ULN) and
  • AST y ALT <=2,5 x ULN and
  • Serum creatinine <=1,0 mg/dL of serum creatinine <01,0 mg/dL, then, glomerular filtration rate (GFR) estimated must be >60 mL/min/1,73 m2 calculated from the equation of the Modification of Diet in Renal Disease (MDRD).
  • Adequate cardiac function determined by at least one of the following:
  • Left ventricular ejection fraction (LVEF) >=40% measured by echocardiography in Multiple Gated Acquisition (MUGA) scan or isotope angiography or
  • Left ventricular fractional shortening >=22% measured by echocardiography.

Who cannot join

  • Diagnosis of acute promyelocytic leukaemia (APL) in French-American-British classification M3º or attending to the WHO classification t(15;17)(q22;q12), (PML/RAR and variants).
  • Pre-treatment with clofarabine.
  • Previous treatment for AML or a hematological disorder AHD (excluding palliative care, hydroxyurea, hematopoietic cytokines or lenalidomide [the latter only for a specific AHD]). Hematopoietic cytokines and lenalidomide should not have been administered within the 14 days preceding the first dose of study drug. If it is received any previous treatment for AML or AHD within the time limits allowed, drug-related toxicity, must have recovered to Grade 1 or less before the first dose of study drug.
  • Previous hematopoietic stem cell transplantation (HSCT).
  • External beam pelvic radiotherapy.
  • Have received an investigational product within 30 days before the first dose of study drug. If the patient has received any investigational product before this time, the drug-related toxicity, must have recovered to Grade 1 or less before the first dose of study drug.
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  • Inadequate renal and hepatic function as follows:
  • Total bilirubin >1,5 x institutional upper limit normal (ULN) provided it is not attributable to the very LMA or
  • AST y ALT >2,5 x ULN provided it is not attributable to the very LMA or
  • Serum creatinine >1,0 mg/dL provided that the glomerular filtration rate (GFR) estimated to be ≤60 mL/min/1,73 m2 calculated by the equation of the Modification of Diet in Renal Disease (MDRD).
  • Inadequate cardiac function determined by at least one of the following:
  • Left ventricular ejection fraction <40% measured by echocardiography in Multiple Gated Acquisition (MUGA) or isotope angiography; or
  • Left ventricular fractional shortening <22% measured by echocardiography.
  • Poor general condition ECOG 3-4.
  • Refusal to sign informed consent form.
  • Inability to comply with study visits and inspections.
  • Psychiatric disorders that could interfere with the consent, participation or monitoring of the study.
  • Fungal Systemic disease, bacterial, viral or other uncontrolled infection (defined as manifestation of signs / symptoms related to ongoing infection and without improvement, although receiving adequate antibiotic therapy or other treatment).
  • Any other concomitant serious disease or a history of severe organ dysfunction or heart, kidney, liver or other organ system which may involve the patient in excessive risk when exposed to clofarabine.
  • Diagnosis of another malignancy neoplasia, unless the patient has been disease-free for at least five years after completing an attempt curative therapy with the following exceptions:
  • Patients with non-melanoma skin cancer, carcinoma in situ or cervical intraepithelial neoplasia, irrespective of the duration of disease-free period, are eligible for the study if it has finalized a definitive treatment for the disease.
  • Patients with prostate cancer confined to the organ without evidence of recurrent or progressive disease based on figures for the prostate specific antigen (PSA) are also candidates for the study if hormonal therapy has been initiated or has made a radical prostatectomy.
  • Clinical evidence which may indicate central nervous system (CNS) leukemia unless lumbar puncture to confirm the absence of leukemic blasts in the cerebrospinal fluid (CSF).
  • Previous positive test for human immunodeficiency virus (HIV).

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Spain15 sites

  • Hospital Juan Canalejo.

    A Coruña

  • Hospital General de Alicante.

    Alicante

  • Hospital de la Santa Creu i Sant Pau.

    Barcelona

  • Hospital Durán i Reynals (Bellvitge).

    Barcelona

  • Hospital Vall d' Hebron

    Barcelona

  • ICO Hospital Germans Trias I Pujol.

    Barcelona

  • Hospital Reina Sofía.

    Córdoba

  • Hospital 12 de Octubre.

    Madrid

  • Hospital Ramón y Cajal.

    Madrid

  • Hospital San Pedro de Alcántara.

    Málaga

  • Hospital Central de Asturias.

    Oviedo

  • Hospital Clínico Universitario de Salamanca.

    Salamanca

  • Hospital Virgen del Rocío

    Seville

  • Hospital Clínico de Valencia.

    Valencia

  • Hospital Universitario La Fe.

    Valencia

Other trials in Spain

About this study

Official title: Multicentric Phase II Trial, Prospective, Open, Single Group, to Discuss Induction Therapy With a Combination of Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy With Clofarabine and Low-dose Cytarabine for the Treatment of AML Patients Age Greater Than or Equal to 60 Years

Primary outcome measure:

Evaluate the efficacy in terms of complete responses of induction therapy and first-line consolidation of Clofarabine and low-dose Cytarabine with AML patients aged 60 years or more. The first efficacy objective is evaluate the overall remission rate (TRG), where general reference (RG) is defined as a patient who achieved complete remission (CR) or complete remission with inadequate platelet recovery (CPR).

Read more

Secondary outcome measures:

  • To evaluate disease-free survival (DFS)
  • Evaluate the overall survival (OS)
  • To evaluate the safety and tolerability of clofarabine and duration, severity and relationship of adverse events (AEs) occurring during treatment
  • To assess the rate of mortality at 30 days (ie, the incidence of deaths occurring between Day 1 and Day 30 of induction cycle)
  • The incidence, intensity (according to the latest version of the CTCAE classification), duration, causality, severity and type of AA
Read the detailed description

This protocol corresponds to a multicenter, phase II, open, non randomized, designed to determine the efficacy of clofarabine and low-dose cytarabine combination in AML patients older than or equal to 60 years.

The trial is divided into pre-treatment and treatment (cycle / s of induction and consolidation) periods.The induction cycle consist of clofarabine at 20 mg/m2/day intravenously for 5 consecutive days plus cytarabine subcutaneously at 20 mg/m2/day for 14 consecutive days. If patients do not achieve CR they will receive a second course of induction with the same pattern. Consolidation cycles consist of clofarabine intravenously at 15 mg/m2/day for 5 consecutive days plus cytarabine at 20 mg/m2/day subcutaneously for 7 consecutive days. Patients will receive a maximum of 12 cycles of clofarabine and LDAC. The monitoring phase of survival is made by clinical practice and will continue until all patients have either died or survived two years after the end of treatment visit.

There will be 75 patients older than or equal to 60 years. Patients will be evaluated over the following periods: Pre-treatment and treatment (induction and consolidation).

Pre-treatment phase: includes enrolment visit in which the patient completes the written informed consent to participate in the study.

There will be a selection of patients who have given their written informed consent to join the clinical trial. They must meet all the inclusion criteria and no exclusion.

Treatment phase: Patients should begin treatment within 14 days after signing the informed consent form (ICF). Selection period begins when the ICF is signed and the inclusion period begins when the patient first receives the study drug (ie Day 1 of the induction cycle).

Safety will be evaluated by monitoring all adverse events haematological and not haematological related with the drug's study.

The final visit of treatment will take place at least 45 days after the last dose of study drug administration.

Patients who leave the study prematurely, should have the end of treatment visit within 2 weeks after the decision not to continue to administer the study drug. The final visit should take place within 2 weeks after the visit of the last cycle of treatment.

Off protocol, after making the final visit of, all patients receiving at least one dose of study drug will be subject to monitoring by normal clinical practice, for a minimum of two years from the final visit or until his death

Follow up phase:

The maximum follow-up for all patients is 2 years from the final visit of the last patient included and be conducted on a monthly basis during the first year and quarterly during the second at least, notwithstanding that there may be more visits at discretion of each centre or depending on the clinical features.

Being tested
Clofarabine, Cytarabine
Keywords
Acute myelogenous leukemia, Clofarabine, Cytarabine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

Study groups in NCT01193400
Study groupRoleWhat they receive
Clofarabine-CytarabineExperimentalInduction therapy with a combination of clofarabine and low-dose cytarabine followed by consolidation therapy with clofarabine and low-dose cytarabine
Receives: Drug: Clofarabine; Drug: Cytarabine

What is being measured

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

  1. Efficacy

    Evaluate the efficacy in terms of complete responses of induction therapy and first-line consolidation of Clofarabine and low-dose Cytarabine with AML patients aged 60 years or more. The first efficacy objective is evaluate the overall remission rate (TRG), where general reference (RG) is defined as a patient who achieved complete remission (CR) or complete remission with inadequate platelet recovery (CPR).

    Measured: 1 year

Secondary outcomes (5)

  1. To evaluate disease-free survival (DFS)

  2. Evaluate the overall survival (OS)

  3. To evaluate the safety

  4. To assess the rate of mortality at 30 days

  5. • The incidence, intensity (according to the latest version of the CTCAE classification), duration, causality, severity and type of AE

Timeline

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

  1. First posted1 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

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
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01193400
Sponsor's protocol ID
AML-CLOFARA-CA09
Other IDs
2010-019718-25
Status last verified
Apr 2014
First submitted
31 Aug 2010
Last updated
7 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Martinez-Cuadron D, Montesinos P, Oriol A, Salamero O, Vidriales B, Bergua J, Herrera P, Vives S, Sanz J, Carpio C, Rodriguez-Veiga R, Moscardo F, Sanz MA. Phase II trial to assess the safety and efficacy of clofarabine in combination with low-dose cytarabine in elderly patients with acute myeloid leukemia. Ann Hematol. 2014 Jan;93(1):43-6. doi: 10.1007/s00277-013-1914-y. Epub 2013 Oct 1.

    PubMed 24081577

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clofarabine and Cytarabine in people with Acute Myelogenous Leukemia, run by PETHEMA Foundation at 15 sites in Spain.

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

Who may be eligible to take part?

The sponsor lists 19 inclusion and 24 exclusion criteria. 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: stopped early, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. 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?

The study was stopped early. Results are not available in the source record.

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?

Efficacy (time frame: 1 year). 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 NCT01193400, which also lists 1 linked publication.

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 7 Apr 2014.

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