AzTrials
AzTrials

LeukemiaPhase 1/2AML-14ANCT00838240

Clofarabine, Cytarabine, and Idarubicin in Treating Patients With Intermediate-Risk or High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplasia

A Phase 1/2 study testing clofarabine, cytarabine and idarubicin in people with Leukemia and Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine, cytarabine, and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Leukemia, Myelodysplastic Syndromes
What is being tested?
clofarabine, cytarabine and idarubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
10 sitesin 5 countries
Study dates
Nov 2008to Dec 2012
Phase
Phase 1/2
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following by WHO criteria:
  • Acute myeloid leukemia (AML) (≥ 20% bone marrow blasts by bone marrow aspiration or biopsy)
  • No acute promyelocytic leukemia (M3)
  • All cytogenetic groups allowed, except for the following:
  • t(15;17)
  • t(8;21) or inv(16) AND a WBC count at diagnosis of < 100,000/μL
  • Primary or secondary AML allowed, including AML after myelodysplasia (MDS)
  • High-risk MDS (≥ 10% bone marrow blasts by bone marrow aspiration or biopsy)
  • No chronic myelogenous leukemia in blast crisis or AML supervening a myeloproliferative disorder
  • Previously untreated disease, except for ≤ 14 days of hydroxyurea
  • No CNS leukemia

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Serum creatinine ≤ 1.0 mg/dL or glomerular filtration rate > 60 mL/min
  • AST/ALT ≤ 2.5 times upper limit of normal (ULN)
  • ALP ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for ≥ 3 months after completion of study treatment
  • No active uncontrolled infection
  • No HIV positivity
  • No psychological, familial, sociological, or geographical conditions precluding compliance with study treatment or follow up
  • No concurrent severe uncontrolled cardiovascular disease (i.e., symptomatic congestive heart failure or symptomatic ischemic heart disease [NYHA class III-IV])
  • No concurrent malignant disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent cytotoxic drugs or experimental therapies (e.g., antiangiogenic drugs, tyrosine kinase inhibitors)

Trial locations and contacts

10 sites in 5 countries.

Hilde Breyssens contact

hilde.breyssens@eortc.be

10 sites in 5 countries

Belgium3 sites, 3 recruiting

  • A.Z. Sint-Jan

    Bruges

    Dominik Selleslag

    Recruiting

  • Institut Jules Bordet

    Brussels

    Dominique Bron

    Not yet recruiting

  • CHU Sart-Tilman

    Liège

    Frédéric Baron

    Not yet recruiting

Other trials in Belgium

Netherlands3 sites, 2 recruiting

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

    Hans Pruijt

    Recruiting

  • Leiden University Medical Center

    Leiden

    Active, not recruiting

  • Radboud University Nijmegen Medical Center

    Nijmegen

    Petra Muus

    Recruiting

Other trials in Netherlands

Italy2 sites, 2 recruiting

  • Azienda Ospedallera Universitaria - Policlinico Tor Vergata

    Roma

    Sergio Amadori

    Recruiting

  • Univesita Degli Studi "La Sapienza"

    Roma

    Giovanna Meloni

    Recruiting

Other trials in Italy

Croatia1 site, 1 recruiting

  • University Hospital Rebro

    Zagreb

    Boris Labar

    Not yet recruiting

Other trials in Croatia

France1 site, 1 recruiting

  • Hôpital Saint Antoine AP-HP

    Paris

    Olivier Legrand

    Not yet recruiting

Other trials in France

About this study

Official title: Clofarabine in Combination With a Standard Remission Induction Regimen (AraC and Idarubicin) in Patients 18-60 Years Old With Previously Untreated Intermediate and Bad Risk Acute Myelogenous Leukemia (AML) or High Risk Myelodysplasia (MDS) : a Phase I-II Study of the EORTC-LG and GIMEMA (AML-14A Trial)

RATIONALE: Drugs used in chemotherapy, such as clofarabine, cytarabine, and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works when given together with cytarabine and idarubicin in treating patients with intermediate-risk or high-risk acute myeloid leukemia or high-risk myelodysplasia.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the optimum dose of clofarabine in combination with cytarabine and idarubicin in patients with previously untreated intermediate- and high-risk acute myeloid leukemia or high-risk myelodysplasia. (Phase I)
  • To determine the safety and tolerance of this regimen in order to determine the recommended phase II dose. (Phase I)
  • To explore the antitumor activity of this regimen in these patients. (Phase II)
  • To determine the activity expressed as complete remission (CR)/CR with incomplete hematopoietic recovery (CRi) rate following induction therapy. (Phase II)

Secondary

  • To determine the activity expressed as CR/CRi rate following induction (1 or 2 courses) and consolidation therapy. (Phase I)
  • To determine hematopoietic recovery (platelets and neutrophils) after induction and consolidation therapy.
  • To determine safety and tolerability of this regimen. (Phase II)
  • To determine activity expressed as CR/CRi rate after consolidation therapy. (Phase II)
  • To determine feasibility of blood CD34 harvesting after consolidation therapy. (Phase II)
  • To determine disease-free and overall survival from CR/CRi. (Phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study of clofarabine followed by an randomized phase II study. Patients are stratified according to center, and presence of poor prognostic features (WBC at diagnosis ≥ 100,000/μL vs presence of very high risk cytogenetic features -5/5q-, -7/7q-, presence of complex abnormalities [> 3 abnormalities], 3q, t[6;9], or t[9;22]). Patients are randomized to 1 of 2 treatment arms.

  • Induction therapy:
  • Arm I: Patients receive idarubicin IV over 5 minutes on days 1, 3, and 5, cytarabine IV continuously on days 1-10, and clofarabine IV over 1 hour on days 2, 4, 6, 8, and 10.
  • Arm II: Patients receive idarubicin IV and cytarabine IV as in arm I. Patients also receive clofarabine IV by push injection over 10 minutes on days 2, 4, 6, 8, and 10.
  • Consolidation therapy: Patients receive cytarabine IV over 2 hours every 12 hours on days 1-6 and idarubicin IV over 5 minutes once daily on days 4-6.

After completion of study therapy, patients are followed periodically for 12 months.

Being tested
clofarabine, cytarabine, idarubicin
Keywords
adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), 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), untreated adult acute myeloid leukemia, de novo myelodysplastic syndromes, secondary acute myeloid leukemia
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute, Congenital Abnormalities

What participants receive

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

Study groups in NCT00838240
Study groupRoleWhat they receive
Arm IExperimentalPatients receive idarubicin IV over 5 minutes on days 1, 3, and 5, cytarabine IV continuously on days 1-10, and clofarabine IV over 1 hour on days 2, 4, 6, 8, and 10.
Receives: Drug: clofarabine; Drug: cytarabine; Drug: idarubicin
Arm IIExperimentalPatients receive idarubicin IV and cytarabine IV as in arm I. Patients also receive clofarabine IV by push injection over 10 minutes on days 2, 4, 6, 8, and 10.
Receives: Drug: clofarabine; Drug: cytarabine; Drug: idarubicin

What is being measured

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

  1. Toxicity as assessed by CTCAE v3.0 (Phase I)

  2. Response rate (Phase II)

Secondary outcomes (6)

  1. Toxicity as assessed by CTCAE v3.0 (Phase II)

  2. Response rate (Phase I)

  3. Duration of survival

  4. Duration of survival from complete remission (CR)/CR with incomplete hematopoietic recovery (CRi) rate

  5. Disease-free survival from CR/CRi

  6. Incidence of relapse and incidence of death in CR/CRi

Timeline

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

  1. First posted6 Feb 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionDec 2012 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00838240
Sponsor's protocol ID
EORTC-06061
Other IDs
EORTC-06061, EU-20905, 2006-004912-28, GIMEMA-AML-14A
Acronym
AML-14A
Status last verified
Jul 2012
First submitted
5 Feb 2009
Last updated
20 Jul 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing clofarabine, cytarabine and idarubicin in people with Leukemia and Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 5 countries.

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: status not confirmed, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Belgium, Netherlands, Italy, Croatia, France. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

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

Contact Hilde Breyssens (hilde.breyssens@eortc.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity as assessed by CTCAE v3.0 (Phase I). The study lists 2 primary outcomes in all. 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 NCT00838240.

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 20 Jul 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in