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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Junmin Li, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01755325
First received: December 18, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Chronic Myelogenous Leukemia
Drug: Compound realgar natural indigo Tablet
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Compound Realgar Formula Realgar-Indigo Naturalis Plus Imatinib Versus Placebo Plus Imatinib in Adult Patients With Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Resource links provided by NLM:


Further study details as provided by Ruijin Hospital:

Primary Outcome Measures:
  • To compare the rate of Major molecular response(MMR) at 12 months [ Time Frame: 12 months of follow-up from the start of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 680
Study Start Date: November 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Compound realgar natural indigo Tablet

Compound realgar natural indigo Tablet, 2.7g tablet, tid, from day1 to day14,every 4 weeks.

imatinib,0.4g,qd

Drug: Compound realgar natural indigo Tablet

Compound realgar natural indigo Tablet, 2.7g tablet, tid, from day1 to day14,every 4 weeks.

imatinib,0.4g,qd

Placebo Comparator: placebo

placebo tablet, 2.7g, tid, from day1 to day14,every 4 weeks.

imatinib 0.4g qd

Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients, age >= 18 years and <= 75 years.
  2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0, 1, or 2.
  3. Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome positive.(Ph+ CML-CP)
  4. Ph+ Chronic myelogenous leukemia in chronic phase patients within the first 12 months of diagnosis.
  5. 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.

Exclusion Criteria:

1. Previously received or be receiving any of the following medical treatment for CML:

  1. . Treatment with Busulfan within 1 day prior to study entry.
  2. . Treatment with interferon-alpha within 2 days prior to study entry.
  3. . Treatment with hydroxyurea within 1 day prior to study entry.
  4. . Treatment with homoharringtonine within 14 days prior to study entry.
  5. . Treatment with Cytosine arabinoside within 28 days prior to study entry.
  6. . Surgery (Including hematopoietic stem cell transplantation therapy)
  7. . Treatment with anthracyclines, or etoposide within 21 days prior to study entry.

2. 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.

4. Major surgery within 4 weeks prior to randomization or who have not recovered from prior surgery.

5. Patients who have not recovered from toxic reaction of prior similar treatment evaluated by investigators.

6. Impaired cardiac function including any one of the following:

  1. LVEF < 45%.
  2. . Complete left bundle branch block.
  3. . Use of a ventricular-paced pacemaker.
  4. . Congenital long QT syndrome.
  5. . History or presence of ventricular, clinically significant atrial tachyarrhythmias
  6. . History or presence of clinically significant bradyarrhythmia.(heart rate persistently less than 50/min)
  7. . QTcF > 450 msec for male or 470 msec for female.
  8. . History of clinically documented myocardial infarction or unstable angina (during the last 12 month).
  9. .Any other severe heart disease. 7. Patients with active, uncontrolled psychiatric disorders, without insight and the ability of exact expression.

8. Uncontrolled medical conditions:

  1. .Uncontrolled diabetes with fasting blood-glucose >200mg/dl (11.1mmol/L),or with combined symptoms (nephropathy, peripheral neuropathy).
  2. . Uncontrolled hypertension.
  3. . Active or uncontrolled infection (persistent fever and worsening of the clinical symptoms) 9. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the tested drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery).

10. History of chronic pancreatitis or history of acute pancreatitis within 1 year of study entry.

11. Acute or chronic uncontrolled liver disease or severe renal disease considered unrelated to CML.

12. Patients actively receiving therapy with strong CYP3A4 inhibitors, strong CYP3A4 inducers or any medications being potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.

13. Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks prior to randomization.

14. Known to be allergic to the study drugs, including crude drug or adjuvant. 15. As investigators evaluate, the patients do not fit to join the study (such as with severe complications) .

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755325

Locations
China, Hubei
Union Hospital medical college Huazhong University of Science and Technology
Wuhan, Hubei, China
China, Jiangsu
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
First Hospital Affiliated to Suzhou University
Suzhou, Jiangsu, China
China, Liaoning
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
China, Shanxi
Xijing Hospital-Fourth Military Medical University
Xi'an, Shanxi, China
China, Zhejiang
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
China
The People's Hospital of Peking University
Peking, China
Ruijin Hospital
Shanghai, China
Sponsors and Collaborators
Junmin Li
Investigators
Study Chair: Saijuan Chen, M.D. Runjin Hospital
  More Information

No publications provided

Responsible Party: Junmin Li, Director of hematology department, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01755325     History of Changes
Other Study ID Numbers: RJ-CYP001
Study First Received: December 18, 2012
Last Updated: December 18, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014