Phase III Study of Compound Formula Realgar-Indigo Naturalis Plus Imatinib Versus Placebo Plus Imatinib in Adult CML-CP Patients With Ph+

NCT01755325 | Suspended Phase 3 DMC

• 1 other identifier: RJ-CYP001
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 13

Brief Summary

It is an open-label, randomized, double blind, placebo-controlled parallel-group, multi-center study to evaluate the efficacy and safety of Compound realgar formula Realgar-Indigo naturalis Tablet combined with Imatinib will be compared with imatinib alone in adult patients with diagnosed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia in the chronic phase (CML-CP).

Conditions

Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (1)

• To compare the rate of Major molecular response（MMR） at 12 months

  12 months of follow-up from the start of treatment

Study Arms (2)

Compound realgar natural indigo Tablet

EXPERIMENTAL

Compound realgar natural indigo Tablet, 65mg/kg/d, from day1 to day14,every 4 weeks. imatinib,0.4g,qd

Drug: Compound realgar natural indigo Tablet

placebo

PLACEBO COMPARATOR

placebo tablet,65mg/kg/d, from day1 to day14,every 4 weeks. imatinib 0.4g qd

Drug: placebo

Interventions

Compound realgar natural indigo Tablet DRUG

Compound realgar natural indigo Tablet, 65mg/kg/d, from day1 to day14,every 4 weeks. imatinib,0.4g,qd

Compound realgar natural indigo Tablet

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, age \>= 18 years and \<= 75 years.
• Eastern Cooperative Oncology Group （ECOG） performance status (PS) score 0, 1, or 2.
• Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome positive.(Ph+ CML-CP)
• Ph+ Chronic myelogenous leukemia in chronic phase patients within the first 12 months of diagnosis.
• Adequate end organ function as defined by:
• (1). Alanine transaminase（ALT）, Aspartate transaminase（AST） \<=2.5 x upper limit of normal（ULN）.
• (2). Total bilirubin \<= 1.5 x ULN. (3).Cr \<= 1.5 x ULN. (4). Serum amylase and lipase \<= 1.5 x ULN. 6. Signed informed consent.

You may not qualify if:

• \. Previously received or be receiving any of the following medical treatment for CML:
• Treatment with Busulfan within 1 day prior to study entry.
• Treatment with interferon-alpha within 2 days prior to study entry.
• Treatment with hydroxyurea within 1 day prior to study entry.
• Treatment with homoharringtonine within 14 days prior to study entry.
• Treatment with Cytosine arabinoside within 28 days prior to study entry.
• Surgery (Including hematopoietic stem cell transplantation therapy)
• Treatment with anthracyclines, or etoposide within 21 days prior to study entry.
• \. Treatment with any tyrosine kinase inhibitor(s) or arsenic reagent prior to study entry 3. Patients who are: (a) pregnant, (b) breast feeding, (c) female or male of childbearing potential unwilling to use contraceptive precautions throughout the trial.
• \. Major surgery within 4 weeks prior to randomization or who have not recovered from prior surgery.
• \. Patients who have not recovered from toxic reaction of prior similar treatment evaluated by investigators.
• \. Impaired cardiac function including any one of the following:
• LVEF \< 45%.
• Complete left bundle branch block.
• Use of a ventricular-paced pacemaker.

Sponsors & Collaborators

• Junmin Li: lead

Study Sites (13)

Union Hospital medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

The NO.1 People's Hospital of Huaian

Huaian, Jiangsu, 223002, China

Location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Location

First Hospital Affiliated to Suzhou University

Suzhou, Jiangsu, China

Location

The FIrst Affiliated Hospital, College of Medicine, Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The Second Affiliated Hospital, College of Medicine, Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The Tumor Hospital of Jiangxi

Nanchang, Jiangxi, 330029, China

Location

The NO.1 Hospital of Nanchang

Nanchang, Jiangxi, 333008, China

Location

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Xijing Hospital-Fourth Military Medical University

Xi'an, Shan'xi, China

Location

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

The People's Hospital of Peking University

Beijing, China

Location

Ruijin Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saijuan Chen, M.D.

  Runjin Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of hematology department

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 24, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

CN (13)