Evaluation of the Therapeutic Effect of HU Pulse Therapy... | NCT03515018

Studies
Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients

NCT03515018

Sponsor

First Affiliated Hospital of Harbin Medical University

Status

Unknown status

Last Update Posted

May 22, 2018Actual

Enrollment

60Estimated

Phase

Phase 3

Conditions

Leukemia, Chronic Myeloid

Interventions

hydroxyurea
Imatinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

May 1, 2020Estimated

Completion Date

May 1, 2020Estimated

First Submitted Date

Apr 16, 2018

First Submission Date that Met QC Criteria

May 2, 2018

First Posted Date

May 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2018

Last Update Posted Date

May 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydroxyurea	Experimental	Drug: hydroxyurea, pulse therapy	Drug: hydroxyurea
imatinib	Active Comparator	Drug: imatinib, 400mg PO per day	Drug: Imatinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hydroxyurea	Drug	pulse therapy	Hydroxyurea	HU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
white blood cell count	white blood cell count decreased by 10%, 20%, 30%, 50%	2 years

Secondary Outcomes

Measure	Description	Time Frame
spleen size	spleen size reduced 10%, 20%, 30%, 50%	2 years
complete remission	the time to achieve complete remission	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Patients treated with any chemotherapy drugs.
Patients younger than 16 years.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin Zhou, MD, PhD	Contact	008645185555951		zhoujin1111@126.com

Overall Officials

Name	Affiliation	Role
Jin Zhou, MD, PhD	First Affiliated Hospital of Harbin Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital of Harbin Medical University	Recruiting	Harbin	Heilongjiang	150001	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28416739	Background	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.
27751981

ID	Term
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D015466	Leukemia, Myeloid, Chronic-Phase

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D006918	Hydroxyurea
D000068877	Imatinib Mesylate

ID	Term
D014508	Urea
D000577	Amides
D009930	Organic Chemicals
D001549	Benzamides
D001565