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Chronic Myelogenous LeukemiaPhase 3NCT01755325

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

A Phase 3 study testing Compound realgar natural indigo Tablet in people with Chronic Myelogenous Leukemia, run by Junmin Li at 13 sites in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Myelogenous Leukemia
What is being tested?
Compound realgar natural indigo Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
680 participants
Where
13 sitesChina
Study dates
Nov 2012to Dec 2018
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1. 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.
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  • . Surgery (Including hematopoietic stem cell transplantation therapy)
  • . 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:
  • LVEF < 45%.
  • . Complete left bundle branch block.
  • . Use of a ventricular-paced pacemaker.
  • . Congenital long QT syndrome.
  • . History or presence of ventricular, clinically significant atrial tachyarrhythmias
  • . History or presence of clinically significant bradyarrhythmia.(heart rate persistently less than 50/min)
  • . QTcF > 450 msec for male or 470 msec for female.
  • . History of clinically documented myocardial infarction or unstable angina (during the last 12 month).
  • .Any other severe heart disease. 7. Patients with active, uncontrolled psychiatric disorders, without insight and the ability of exact expression.
  • 8. Uncontrolled medical conditions:
  • .Uncontrolled diabetes with fasting blood-glucose >200mg/dl (11.1mmol/L),or with combined symptoms (nephropathy, peripheral neuropathy).
  • . Uncontrolled hypertension.
  • . 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) .

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • The People's Hospital of Peking University

    Beijing

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang

  • The NO.1 People's Hospital of Huaian

    Huaian, Jiangsu, 223002

  • The FIrst Affiliated Hospital, College of Medicine, Nanchang University

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital, College of Medicine, Nanchang University

    Nanchang, Jiangxi, 330006

  • The Tumor Hospital of Jiangxi

    Nanchang, Jiangxi, 330029

  • The NO.1 Hospital of Nanchang

    Nanchang, Jiangxi, 333008

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu

  • Ruijin Hospital

    Shanghai

  • First Hospital Affiliated to Suzhou University

    Suzhou, Jiangsu

  • Union Hospital medical college Huazhong University of Science and Technology

    Wuhan, Hubei

  • Xijing Hospital-Fourth Military Medical University

    Xi'an, Shan'xi

Other trials in China

About this study

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)

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).

Being tested
Compound realgar natural indigo Tablet, placebo
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compound realgar natural indigo TabletDrug

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

    imatinib,0.4g,qd

  • placeboDrug

Study groups in NCT01755325
Study groupRoleWhat they receive
Compound realgar natural indigo TabletExperimentalCompound realgar natural indigo Tablet, 65mg/kg/d, from day1 to day14,every 4 weeks. imatinib,0.4g,qd
Receives: Drug: Compound realgar natural indigo Tablet
placeboPlacebo comparatorplacebo tablet,65mg/kg/d, from day1 to day14,every 4 weeks. imatinib 0.4g qd
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months of follow-up from the start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Why it stopped: not enough patients

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
680 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01755325
Sponsor's protocol ID
RJ-CYP001
Status last verified
Apr 2018
First submitted
18 Dec 2012
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Compound realgar natural indigo Tablet in people with Chronic Myelogenous Leukemia, run by Junmin Li at 13 sites 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 7 inclusion and 30 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: paused, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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. Some participants in this study may receive a placebo. 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?

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?

To compare the rate of Major molecular response（MMR） at 12 months (time frame: 12 months of follow-up from the start of treatment). 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 NCT01755325.

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 25 Apr 2018.

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