Acute Myeloid LeukemiaPhase 4NCT02277847
Idarubicin at Different Dosages as Induction Therapy for Newly Diagnosed Acute Myeloid Leukaemia
A Phase 4 study testing Idarubicin(8mg/m2) and cytosine arabinoside and Idarubicin(10mg/m2), cytosine arabinoside in people with Acute Myeloid Leukemia, run by Guangdong Provincial People's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Idarubicin(8mg/m2) and cytosine arabinoside and Idarubicin(10mg/m2), cytosine arabinoside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jun 2017
- Phase
- Phase 4
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Phase IV, Randomized Study to Evaluate the Safety and Efficacy of Idarubicin at Different Dosages Combined With Cytarabine as Induction Therapy for Newly Diagnosed Acute Myeloid Leukaemia
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.
Read the detailed description
Idarubicin is a new generation of anthracyclines with high lipophilicity and is more permeable to cytomembrane and therefore is more cytotoxic to leukemic cells. It can pass through the blood brain barrier easily. so IDA has more advantages over other anthracyclines in prolonging the overall survival for AML. The induction therapy with idarubicin and cytarabine is now the first-line induction regimen for AML. Many clinical trails have indicated that the dosage of IDA is positively correlated with its effectiveness. But in China IDA has been used in varied dosages ranging from 6 to 12 mg/m2. In most Chinese hospitals, the usual dosage range of IDA is from 6 to 8 mg/m2 which may contribute to the much lower 5-year survival rates of AML reported in Chinese medical literature than those in foreign literature. What is the suitable dosage of IDA as induction therapy for Chinese AML population with the best efficacy but the lest increase of side effects? Till now there is no retrospective, randomized and multicentered clinical trails to answer this question on remission-inducing dosages of IDA. All the existing trials till now are just small- sampled , single-centered , retrospective and non-randomized which can not provide strong evidences .
This study aims at comparing two induction doses of 8mg/m2 and 10mg/m2 of IDA with the method of prospective randomized and multi-centered trial.The two doses of IDA have been used in many Chinese hospitals for many years, its effectiveness and safety have been recognized. This trail aims at the and side effects of IDA during induction therapy and its effect on the long-term survival of Chinese AML population, so it can provide strong evidences for optimal dosage of IDA for Chinese AML population.It can not only reduce the waste of medical social resources but also produce good social and economic benefits.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Idarubicin(8mg/m2) and cytosine arabinoside, Idarubicin(10mg/m2), cytosine arabinoside
- Keywords
- Idarubicin, Cytosine arabinoside, Efficacy, Safety
- 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.
Idarubicin(8mg/m2) and cytosine arabinosideDrug
Also called Idarubicin, Cytosine arabinoside, Acute myeloid leukemia, Safety
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.
Idarubicin(10mg/m2), cytosine arabinosideDrug
Also called Idarubicin, Cytosine arabinoside, Acute myeloid leukemia, Safety
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Idarubicin(10mg/m2), cytosine arabinoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival(OS) and Disease free survival rate (DFS)
Measured: Within 5 years after randomization
Secondary outcomes (1)
Induction remission rate
Measured: Within one month after induction therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startMar 2010
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Du, MD.PhD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277847
- Sponsor's protocol ID
- GDREC.[2010]017
- Status last verified
- Oct 2014
- First submitted
- 25 Aug 2014
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18398750Tsimberidou 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.
PubMed 12627513Russo 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.
PubMed 16197446Chaleff 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.
PubMed 22512017Telek 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.
PubMed 22318524
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized Study to Evaluate the Safety and Efficacy of Idarubicin at Different Dosages Combined With Cytarabine as Induction Therapy for Newly Diagnosed Acute Myeloid Leukaemia
- ClinicalTrials.gov ID
- NCT02277847
- Acronym / sponsor ID
- GDREC.[2010]017
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Idarubicin, Cytosine arabinoside, Efficacy, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Idarubicin is a new generation of anthracyclines with high lipophilicity and is more permeable to cytomembrane and therefore is more cytotoxic to leukemic cells. It can pass through the blood brain barrier easily. so IDA has more advantages over other anthracyclines in prolonging the overall survival for AML. The induction therapy with idarubicin and cytarabine is now the first-line induction regimen for AML. Many clinical trails have indicated that the dosage of IDA is positively correlated with its effectiveness. But in China IDA has been used in varied dosages ranging from 6 to 12 mg/m2. In most Chinese hospitals, the usual dosage range of IDA is from 6 to 8 mg/m2 which may contribute to the much lower 5-year survival rates of AML reported in Chinese medical literature than those in foreign literature. What is the suitable dosage of IDA as induction therapy for Chinese AML population with the best efficacy but the lest increase of side effects? Till now there is no retrospective, randomized and multicentered clinical trails to answer this question on remission-inducing dosages of IDA. All the existing trials till now are just small- sampled , single-centered , retrospective and non-randomized which can not provide strong evidences .
This study aims at comparing two induction doses of 8mg/m2 and 10mg/m2 of IDA with the method of prospective randomized and multi-centered trial.The two doses of IDA have been used in many Chinese hospitals for many years, its effectiveness and safety have been recognized. This trail aims at the and side effects of IDA during induction therapy and its effect on the long-term survival of Chinese AML population, so it can provide strong evidences for optimal dosage of IDA for Chinese AML population.It can not only reduce the waste of medical social resources but also produce good social and economic benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDA 8mg/M2 | Experimental | Drug: Idarubicin(8mg/m2) and cytosine arabinosideIDA 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. |
| IDA 10mg/M2 | Active comparator | Drug: Idarubicin(10mg/m2), cytosine arabinosideIDA 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. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Idarubicin(8mg/m2) and cytosine arabinosideAlso: Idarubicin, Cytosine arabinoside, Acute myeloid leukemia, SafetyIDA 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 | IDA 8mg/M2 |
| Idarubicin(10mg/m2), cytosine arabinosideAlso: Idarubicin, Cytosine arabinoside, Acute myeloid leukemia, SafetyIDA 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 | IDA 10mg/M2 |
Primary outcome
Overall survival(OS) and Disease free survival rate (DFS)
Time frame: Within 5 years after randomization
1 secondary outcome
Induction remission rate
Time frame: Within one month after induction therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Results publication: PubMed 18398750Yamashita 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.
- Results publication: PubMed 12627513Tsimberidou 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.
- Results publication: PubMed 16197446Russo 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.
- Results publication: PubMed 22512017Chaleff 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.
- Results publication: PubMed 22318524Telek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Du, MD.PhD principal investigator
Guangdong Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Idarubicin(8mg/m2) and cytosine arabinoside and Idarubicin(10mg/m2), cytosine arabinoside in people with Acute Myeloid Leukemia, run by Guangdong Provincial People's Hospital.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Overall survival(OS) and Disease free survival rate (DFS) (time frame: Within 5 years after randomization). 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 NCT02277847, which also lists 5 linked publications.
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 29 Oct 2014.