Leukemia, Chronic MyeloidPhase 3HUNCT03515018
Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients
A Phase 3 study testing hydroxyurea and Imatinib in people with Leukemia, Chronic Myeloid, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
RATIONALE: Drugs used in chronic-phase chronic myelogenous leukemia (CML) aimed to avoid CML conversion (AP, BC). Hydroxyurea pulse therapy for chronic-phase CML patients is effective based on the investigator's previous studies, and the scheme cost lower than imatinib. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Leukemia, Chronic Myeloid
- What is being tested?
- hydroxyurea and Imatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 May 2020
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Chronic Myelogenous Leukemia (CML) in chronic phase. Patients in either accelerated or blastic phases are not eligible.
- No previous therapy with any drugs.
- Age ≥ 16 years
- Patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible.
- Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.
Who cannot join
- Patients treated with any chemotherapy drugs.
- Patients younger than 16 years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Jin Zhou, MD, PhD, 008645185555951, zhoujin1111@126.com
About this study
Official title: Evaluation of the Therapeutic Effect of Hydroxyurea Pulse Therapy for Chronic Myeloid Leukemia Patients
RATIONALE: Drugs used in chronic-phase chronic myelogenous leukemia (CML) aimed to avoid CML conversion (AP, BC). Hydroxyurea pulse therapy for chronic-phase CML patients is effective based on the investigator's previous studies, and the scheme cost lower than imatinib. It is not yet known the efficacy compared Hydroxyurea pulse therapy with imatinib for chronic-phase CML, especially to achieve hematological remission in short time.
PURPOSE: Non-randomized trial to compare the effectiveness of hydroxyurea pulse therapy with that of imatinib in treating chronic-phase CML patients.
Read the detailed description
OBJECTIVES: I. Compare the time of WBC decreased by 10%,20%,30%,50% of these patients treated with these two drugs. II. Compare the time of spleen size decreased by 10%,20%,30%,50% of chronic-phase chronic myelogenous leukemia patients treated with imatinib to those treated with hydroxyurea pulse therapy. III. Compare the time to achieve complete remission (CR) of these patients treated with these two drugs. iv. Estimate the overall survival, event-free survival, progression-free survival (OS, EFS, PFS) and major cytogenetic response of these patients treated with these two drugs.
OUTLINE: Patients are to receive one of two treatments. Arm I: Induction: Patients receive oral hydroxyurea daily (hydroxyurea pulse therapy) until hematological remission. Maintenance: continuing hydroxyurea pulse therapy to maintain white blood cells below 8. 0 × 109 / L. Arm II: Induction: Patients receive imatinib 400mg qd until acceptable blood counts are achieved. Maintenance: Follow the recommendations of the NCCN guidelines for chronic-phase CML treatment.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 2 years.
- Conditions
- Leukemia, Chronic Myeloid
- Being tested
- hydroxyurea, Imatinib
- Keywords
- Leukemia, Myeloid, Chronic-Phase, hydroxyurea, Imatinib Mesylate, Pulse Therapy, Drug
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxyureaDrug
Also called HU
pulse therapy
ImatinibDrug
Also called Imatinib Mesylate
400mg qd PO per day
| Study group | Role | What they receive |
|---|---|---|
| Hydroxyurea | Experimental | Drug: hydroxyurea, pulse therapy Receives: Drug: hydroxyurea |
| imatinib | Active comparator | Drug: imatinib, 400mg PO per day Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
white blood cell count
white blood cell count decreased by 10%, 20%, 30%, 50%
Measured: 2 years
Secondary outcomes (3)
spleen size
spleen size reduced 10%, 20%, 30%, 50%
Measured: 2 years
complete remission
the time to achieve complete remission
Measured: 2 years
long-term efficacy: OS, EFS, PFS
OS, EFS, PFS
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start1 May 2018
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Chronic MyeloidStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin Zhou, MD, PhD, Study chair, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515018
- Sponsor's protocol ID
- FirstAHHMU
- Acronym
- HU
- Status last verified
- Dec 2017
- First submitted
- 16 Apr 2018
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Valent P, Herndlhofer S, Schneeweiss M, Boidol B, Ringler A, Kubicek S, Gleixner KV, Hoermann G, Hadzijusufovic E, Mullauer L, Sperr WR, Superti-Furga G, Mannhalter C. TKI rotation-induced persistent deep molecular response in multi-resistant blast crisis of Ph+ CML. Oncotarget. 2017 Apr 4;8(14):23061-23072. doi: 10.18632/oncotarget.15481.
PubMed 28416739Huang J, Wang L, Chen L, Qun H, Yajing X, Fangping C, Xielan Z. Changing Treatment May Affect the Predictive Ability of European Treatment Outcome Study Scoring for the Prognosis of Patients with Chronic Myeloid Leukemia. Turk J Haematol. 2017 Mar 1;34(1):10-15. doi: 10.4274/tjh.2016.0156. Epub 2016 Oct 18.
PubMed 27751981
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Effect of Hydroxyurea Pulse Therapy for Chronic Myeloid Leukemia Patients
- ClinicalTrials.gov ID
- NCT03515018
- Acronym / sponsor ID
- HU / FirstAHHMU
- Conditions
- Leukemia, Chronic Myeloid
- Keywords
- Leukemia, Myeloid, Chronic-Phase, hydroxyurea, Imatinib Mesylate, Pulse Therapy, Drug
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 3 May 2018 (actual)
- 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.
RATIONALE: Drugs used in chronic-phase chronic myelogenous leukemia (CML) aimed to avoid CML conversion (AP, BC). Hydroxyurea pulse therapy for chronic-phase CML patients is effective based on the investigator's previous studies, and the scheme cost lower than imatinib. It is not yet known the efficacy compared Hydroxyurea pulse therapy with imatinib for chronic-phase CML, especially to achieve hematological remission in short time.
PURPOSE: Non-randomized trial to compare the effectiveness of hydroxyurea pulse therapy with that of imatinib in treating chronic-phase CML patients.
Detailed description
OBJECTIVES: I. Compare the time of WBC decreased by 10%,20%,30%,50% of these patients treated with these two drugs. II. Compare the time of spleen size decreased by 10%,20%,30%,50% of chronic-phase chronic myelogenous leukemia patients treated with imatinib to those treated with hydroxyurea pulse therapy. III. Compare the time to achieve complete remission (CR) of these patients treated with these two drugs. iv. Estimate the overall survival, event-free survival, progression-free survival (OS, EFS, PFS) and major cytogenetic response of these patients treated with these two drugs.
OUTLINE: Patients are to receive one of two treatments. Arm I: Induction: Patients receive oral hydroxyurea daily (hydroxyurea pulse therapy) until hematological remission. Maintenance: continuing hydroxyurea pulse therapy to maintain white blood cells below 8. 0 × 109 / L. Arm II: Induction: Patients receive imatinib 400mg qd until acceptable blood counts are achieved. Maintenance: Follow the recommendations of the NCCN guidelines for chronic-phase CML treatment.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxyurea | Experimental | Drug: hydroxyureaDrug: hydroxyurea, pulse therapy |
| imatinib | Active comparator | Drug: ImatinibDrug: imatinib, 400mg PO per day |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Chronic Myelogenous Leukemia (CML) in chronic phase. Patients in either accelerated or blastic phases are not eligible.
- No previous therapy with any drugs.
- Age ≥ 16 years
- Patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible.
- Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.
Key exclusion criteria (2 listed)
- Patients treated with any chemotherapy drugs.
- Patients younger than 16 years.
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 |
|---|---|---|
| hydroxyureaAlso: HUpulse therapy | Drug | Hydroxyurea |
| ImatinibAlso: Imatinib Mesylate400mg qd PO per day | Drug | imatinib |
Primary outcome
white blood cell count
Time frame: 2 years
white blood cell count decreased by 10%, 20%, 30%, 50%
3 secondary outcomes
spleen size
Time frame: 2 years
complete remission
Time frame: 2 years
long-term efficacy: OS, EFS, PFS
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Background: PubMed 28416739Valent P, Herndlhofer S, Schneeweiss M, Boidol B, Ringler A, Kubicek S, Gleixner KV, Hoermann G, Hadzijusufovic E, Mullauer L, Sperr WR, Superti-Furga G, Mannhalter C. TKI rotation-induced persistent deep molecular response in multi-resistant blast crisis of Ph+ CML. Oncotarget. 2017 Apr 4;8(14):23061-23072. doi: 10.18632/oncotarget.15481.
- Background: PubMed 27751981Huang J, Wang L, Chen L, Qun H, Yajing X, Fangping C, Xielan Z. Changing Treatment May Affect the Predictive Ability of European Treatment Outcome Study Scoring for the Prognosis of Patients with Chronic Myeloid Leukemia. Turk J Haematol. 2017 Mar 1;34(1):10-15. doi: 10.4274/tjh.2016.0156. Epub 2016 Oct 18.
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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.
Jin Zhou, MD, PhD study chair
First Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hydroxyurea and Imatinib in people with Leukemia, Chronic Myeloid, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
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 5 inclusion and 2 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 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jin Zhou, MD, PhD (008645185555951, zhoujin1111@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
white blood cell count (time frame: 2 years). 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 NCT03515018, which also lists 2 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 22 May 2018.