NCT02277847

Brief Summary

Study Design: Treatment, Randomized, Open Label, Parallel Assignment This study is an open randomized and controlled trial aiming at assessing the efficacy and safety of Idarubicin (IDA) at different doses of 8mg/m2 and 10mg/m2 combined with cytarabine as induction therapy for newly diagnosed Acute Myeloid Leukaemia (AML). All the recruited patients are allocated to group A ( 8mg/m2 group) or group B ( 10mg/m2) in random. It is advised that induction therapy should begain not late than 3 days after randomization. The regimens in detail can be refered in the therapy protocol.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

7.3 years

First QC Date

August 25, 2014

Last Update Submit

October 27, 2014

Conditions

Acute Myeloid Leukemia

Keywords

IdarubicinCytosine arabinosideEfficacySafety

Outcome Measures

Primary Outcomes (1)

  • Overall survival(OS) and Disease free survival rate (DFS)

    Within 5 years after randomization

Secondary Outcomes (1)

  • Induction remission rate

    Within one month after induction therapy

Other Outcomes (1)

  • safety assessment (infection rate during induction therapy, liver and kidney toxicity, therapy related mortality, recovery time of blood count)

    Randomization until death or two years post last subject last treatment visit (or clinical cutoff)

Study Arms (2)

IDA 8mg/M2

EXPERIMENTAL

IDA 8mg/M2 per day, D1-3. iv injection in 10 minutes;Ara-C：100-200mg/M2 per day, D1-7. administration advice: at first, 25 mg/M2 of Ara-C is given by fast intravenous injection, then 100 mg/M2 of Ara-C is given by continuous iv drip for 24 hours for successive 7 days.

Drug: Idarubicin(8mg/m2) and cytosine arabinoside

IDA 10mg/M2

ACTIVE COMPARATOR

IDA 10mg/M2 per day, D1-3. iv. injection in 10mimutes;Ara-C：100-200mg/M2 per day, D1-7. administration advice: at first, 25 mg/M2 of Ara-C is given by fast intravenous injection, then 100 mg/M2 of Ara-C is given by continuous iv drip for 24 hours for successive 7 days.

Drug: Idarubicin(10mg/m2), cytosine arabinoside

Interventions

Idarubicin(8mg/m2) and cytosine arabinosideDRUG

IDA 8mg/M2 per day, D1-3. iv injection in 10 minutes;Ara-C：100-200mg/M2 per day, D1-7. administration advice: at first, 25 mg/M2 of Ara-C is given by fast intravenous injection, then 100 mg/M2 of Ara-C is given by continuous iv drip for 24 hours for successive 7 days.

Also known as: Idarubicin, Cytosine arabinoside, Acute myeloid leukemia, Safety, Efficacy
IDA 8mg/M2
Idarubicin(10mg/m2), cytosine arabinosideDRUG

IDA 10mg/M2 per day, D1-3. iv. injection in 10mimutes;Ara-C：100-200mg/M2 per day, D1-7. administration advice: at first, 25 mg/M2 of Ara-C is given by fast intravenous injection, then 100 mg/M2 of Ara-C is given by continuous iv drip for 24 hours for successive 7 days.

Also known as: Idarubicin, Cytosine arabinoside, Acute myeloid leukemia, Safety, Efficacy
IDA 10mg/M2

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: 14\~60 years old;no gender limit.
  • Diagnosis: according to the diagnosis standards of AML( with the exception of M3 ) ( according to 2008 WHO diagnosis criteria of AML ).
  • Performance status is not bad with Eastern Cooperative Oncology Group (ECOG) score ≤3.
  • Research subjects must sign the informed consent documents.

You may not qualify if:

  • Chronic myelogenous leukemia (CML) in crisis phase.
  • AML transformed from other myeloproliferative diseases.
  • Be accompanied with other progressing neoplasms.
  • With severe malfunction of liver, lungs, kidneys or heart: the plasma levels of direct bilirubin, indirect bilirubin, alanine transaminase, aspartate transaminase and serum creatinine all are 2 times higher than normal, cardiac function is above grade II.
  • With severe infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Yamashita T, Fukushima T, Ueda T. Pharmacokinetic self-potentiation of idarubicin by induction of anthracycline carbonyl reducing enzymes. Leuk Lymphoma. 2008 Apr;49(4):809-14. doi: 10.1080/10428190801947526.

    PMID: 18398750RESULT

  • Tsimberidou A, Estey E, Cortes J, Thomas D, Faderl S, Verstovsek S, Garcia-Manero G, Keating M, Albitar M, O'Brien S, Kantarjian H, Giles F. Gemtuzumab, fludarabine, cytarabine, and cyclosporine in patients with newly diagnosed acute myelogenous leukemia or high-risk myelodysplastic syndromes. Cancer. 2003 Mar 15;97(6):1481-7. doi: 10.1002/cncr.11239.

    PMID: 12627513RESULT

  • Russo D, Malagola M, de Vivo A, Fiacchini M, Martinelli G, Piccaluga PP, Damiani D, Candoni A, Michielutti A, Castelli M, Testoni N, Ottaviani E, Rondoni M, Pricolo G, Mazza P, Zuffa E, Zaccaria A, Raspadori D, Bocchia M, Lauria F, Bonini A, Avanzini P, Gugliotta L, Visani G, Fanin R, Baccarani M. Multicentre phase III trial on fludarabine, cytarabine (Ara-C), and idarubicin versus idarubicin, Ara-C and etoposide for induction treatment of younger, newly diagnosed acute myeloid leukaemia patients. Br J Haematol. 2005 Oct;131(2):172-9. doi: 10.1111/j.1365-2141.2005.05745.x.

    PMID: 16197446RESULT

  • Chaleff S, Hurwitz CA, Chang M, Dahl G, Alonzo TA, Weinstein H. Phase II study of 2-chlorodeoxyadenosine plus idarubicin for children with acute myeloid leukaemia in first relapse: a paediatric oncology group study. Br J Haematol. 2012 Mar;156(5):649-55. doi: 10.1111/j.1365-2141.2011.08976.x.

    PMID: 22512017RESULT

  • Telek B, Rejto L, Kiss A, Batar P, Remenyi G, Szasz R, Ujj ZA, Udvardy M. [Current treatment of acute myeloid leukaemia in adults]. Orv Hetil. 2012 Feb 19;153(7):243-9. doi: 10.1556/OH.2012.29304. Hungarian.

    PMID: 22318524RESULT

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

IdarubicinCytarabineSafety

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAccident PreventionAccidentsPublic HealthEnvironment and Public Health

Study Officials

  • Xin Du, MD.PhD

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

October 29, 2014

Study Start

March 1, 2010

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 29, 2014

Record last verified: 2014-10