Advanced Hodgkin's LymphomaNCT02800447
Procarbazine Hydrochloride Capsule (Natulan®) Clinical Trial Protocol
A study testing Natulan and ABVD in people with Advanced Hodgkin's Lymphoma, run by Lee's Pharmaceutical Limited.
Trial summary
1. To observe and compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for patients with advanced Hodgkin's lymphoma. 2. To evaluate the safety of Natulan® in Chinese patients with advanced Hodgkin's lymphoma Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Hodgkin's Lymphoma
- What is being tested?
- Natulan and ABVD
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2018
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is of age 18~65, both male and female;
- Newly pathologically diagnosed with classical Hodgkin's lymphoma (lymphocyte depletion type, lymphocyte rich type, nodular sclerosing type, and mixed cellularity type), who had not accepted previous treatment;
- Had stage IIB, III or IV disease, as assessed by the Ann Arbor classification;
- ECOG≤2, life expectancy ≥3 month;
- A negative serum pregnancy test required for sexually active women of childbearing potential;
- The subject voluntarily gives written informed consent to participate in the study.
Who cannot join
- Hematopoietic function:
- Leukocyte <3,500/mm3（3.5×109/L）
- Neutrophils <1,500/mm3（1.5×109/L）
- Platelets <100,000/mm3（100×109/L）
- Intolerance to any of the active ingredients and/or excipients in the study medications;
- Severe central nervous system disorders and mental illness;
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- Severe heart disease (congestive heart failure, uncontrolled hypertension, unstable coronary artery disease, or myocardial infarction, or severe arrhythmia). Echocardiography showed resting left ventricular ejection fraction (LVEF) < 50%);
- History of severe lung disease;
- AST or ALT>2.5×ULN，total bilirubin≥1.5×ULN，serum creatinine>1.5×ULN (for subject with liver metastases: AST or ALT>5xULN, total bilirubin ≥ 3xULN);
- Uncontrolled, systemic, active infection；
- Positive serology to HIV;
- HBsAg positive subjects can still be enrolled in the study, but researchers should follow "The consensus on the Treatment of Lymphoma with Hepatitis B Infections" to observe closely and/or provide prophylactic anti-HBV therapy (as per investigator's decision);
- Other previous or concomitant malignancy, except for basal cell carcinoma and/or cervical carcinoma in situ;
- The subject is receiving an investigational drug, or has participated in an investigational study within 30 days prior to screening;
- The subject is pregnant or lactating; or subjects of childbearing potential (both women and man subjects) do not want to take effective contraceptive measures during study period or within 3 months after study completes;
- Investigators believe subjects not suitable to participate in the study for other reasons.
About this study
- To observe and compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for patients with advanced Hodgkin's lymphoma.
- To evaluate the safety of Natulan® in Chinese patients with advanced Hodgkin's lymphoma
Read the detailed description
This is a confirmatory open-label, randomized, controlled, multicenter study. Recruited subjects are to be randomized to treatment group and controlled group, with ratio of 1:1. Treatment group will accept baseline BEACOPP regimen, while controlled group will accept ABVD regimen.
The study design consisted of a screening phase of 1 week, a treatment phase of 24 or 32 weeks, and a post treatment follow-up of at least 2 years.
- Conditions
- Advanced Hodgkin's Lymphoma
- Being tested
- Natulan, ABVD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatulanDrug
Also called Procarbazine hydrochloride capsules
Each baseline BEACOPP regimen lasts 21 days, and each cycle consists of： Cyclophosphamide injection: 650mg/m2, IV infusion, day 1； Doxorubicin hydrochloride injection: 25mg/m2, IV infusion, day 1； Etoposide injection: 100mg/m2, IV infusion, day 1~3; Natulan (procarbazine hydrochloride capsule): 100mg/m2，po, day 1~7; Bleomycin hydrochloride injection: 10mg/m2, IV or IM, day 8; Vincristine: 1.4mg/m2 (single maximum dose is 2mg), IV infusion, day 8; Prednisone tablet: 40mg/m2, po, day 1~14
ABVDDrug
Each ABVD cycle lasts 28 days1 cycle of the ABVD regimen consists of： Doxorubicin hydrochloride injection：25mg/m2，IV infusion，day 1 and 15; Dacarbazine injection：375mg/m2，IV infusion，day 1 and 15； Bleomycin injection：10mg/m2，IV or IM，day 1 and 15； Vincristine injection：1.4mg/m2 (single maximum dose is 2mg), IV infusion，day 1 and 15;
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | baseline BEACOPP regimen Receives: Drug: Natulan |
| controlled group | Active comparator | ABVD regimen Receives: Drug: ABVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate (ORR)
Compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for in patients with advanced Hodgkin's lymphoma.
Measured: 45 months
Secondary outcomes (1)
safety as measured by changes of vital signs, ECG and AE number
Measured: 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hodgkin's LymphomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800447
- Sponsor's protocol ID
- Zhaoke-NTL-2015-01
- Status last verified
- Aug 2018
- First submitted
- 24 May 2016
- Last updated
- 4 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procarbazine Hydrochloride Capsule (Natulan®) Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT02800447
- Acronym / sponsor ID
- Zhaoke-NTL-2015-01
- Conditions
- Advanced Hodgkin's Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- 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.
- To observe and compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for patients with advanced Hodgkin's lymphoma.
- To evaluate the safety of Natulan® in Chinese patients with advanced Hodgkin's lymphoma
Detailed description
This is a confirmatory open-label, randomized, controlled, multicenter study. Recruited subjects are to be randomized to treatment group and controlled group, with ratio of 1:1. Treatment group will accept baseline BEACOPP regimen, while controlled group will accept ABVD regimen.
The study design consisted of a screening phase of 1 week, a treatment phase of 24 or 32 weeks, and a post treatment follow-up of at least 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Natulanbaseline BEACOPP regimen |
| controlled group | Active comparator | Drug: ABVDABVD regimen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is of age 18~65, both male and female;
- Newly pathologically diagnosed with classical Hodgkin's lymphoma (lymphocyte depletion type, lymphocyte rich type, nodular sclerosing type, and mixed cellularity type), who had not accepted previous treatment;
- Had stage IIB, III or IV disease, as assessed by the Ann Arbor classification;
- ECOG≤2, life expectancy ≥3 month;
- A negative serum pregnancy test required for sexually active women of childbearing potential;
Key exclusion criteria (16 listed)
- Hematopoietic function:
- Intolerance to any of the active ingredients and/or excipients in the study medications;
- Severe central nervous system disorders and mental illness;
- Severe heart disease (congestive heart failure, uncontrolled hypertension, unstable coronary artery disease, or myocardial infarction, or severe arrhythmia). Echocardiography showed resting left ventricular ejection fraction (LVEF) < 50%);
- History of severe lung disease;
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 |
|---|---|---|
| NatulanAlso: Procarbazine hydrochloride capsulesEach baseline BEACOPP regimen lasts 21 days, and each cycle consists of： Cyclophosphamide injection: 650mg/m2, IV infusion, day 1； Doxorubicin hydrochloride injection: 25mg/m2, IV infusion, day 1； Etoposide injection: 100mg/m2, IV infusion, day 1~3; Natulan (procarbazine hydrochloride capsule): 100mg/m2，po, day 1~7; Bleomycin hydrochloride injection: 10mg/m2, IV or IM, day 8; Vincristine: 1.4mg/m2 (single maximum dose is 2mg), IV infusion, day 8; Prednisone tablet: 40mg/m2, po, day 1~14 | Drug | Treatment |
| ABVDEach ABVD cycle lasts 28 days1 cycle of the ABVD regimen consists of： Doxorubicin hydrochloride injection：25mg/m2，IV infusion，day 1 and 15; Dacarbazine injection：375mg/m2，IV infusion，day 1 and 15； Bleomycin injection：10mg/m2，IV or IM，day 1 and 15； Vincristine injection：1.4mg/m2 (single maximum dose is 2mg), IV infusion，day 1 and 15; | Drug | controlled group |
Primary outcome
overall response rate (ORR)
Time frame: 45 months
Compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for in patients with advanced Hodgkin's lymphoma.
1 secondary outcome
safety as measured by changes of vital signs, ECG and AE number
Time frame: 45 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Natulan and ABVD in people with Advanced Hodgkin's Lymphoma, run by Lee's Pharmaceutical Limited.
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 6 inclusion and 16 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 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
overall response rate (ORR) (time frame: 45 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2018.