Acute Lymphoblastic LeukemiaPhase 3NCT02070523
Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia:
A Phase 3 study testing VDCLD regimen in people with Acute Lymphoblastic Leukemia, run by Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd. at 1 site in China.
Trial summary
To determine, compared with Daunorubicin(DNR), whether Pegylated liposomal doxorubicin (PLD) inducing higher complete remission (CR) rate, in untreated primary ALL adult patients with VDCLD regimen induction therapy. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- VDCLD regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Dec 2015
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Eligible men or women were age over 14，but less than 60 years;
- Eastern Cooperative Oncology Group performance status of 0 to2;
- Diagnosed with ALL (WHO classification, the primitive cells ≥ 20%);
- Previous untreated ALL patients had not received chemotherapy before (excluding dexamethasone, prednisone, and hydroxyurea). History of receiving blood transfusion, hematopoietic growth factors, vitamin, and palliative measures such as leukocyte removal, dexamethasone, prednisone, hydroxyurea (0.5-3g daily, more than three days) is allowed;
- The levels of LSCs in bone marrow were measured with flow cytometry before treatment;
- Subjects must be able to provide written informed consent.
Who cannot join
- Mixed type of AL patients;
- Clinically significant active infections;
- Nursing (breastfeeding) or intending to be nursing during the study；
- Pregnancy, or intending to become pregnant during the study;
- Patients with cardiac dysfunction currently (especially congestive heart failure) or history of congestive heart failure;
- Patients with severe liver failure (ALT ≥ 5 times the upper limit of normal (ULN), total bilirubin ≥ 3mg/dL)
- Patients with renal insufficiency, creatinine clearance <30ml/min, creatinine clearance rate is calculated as follows: Men: Ccr (ml / min) = (140 - age) × weight (kg) / [0.8136 × serum creatinine (μmol / L )] female: Ccr (ml / min) = (140 - age) × weight (kg) × 0.85 / [0.8136 × serum creatinine (μmol / L)];
- Patients did not or will not participate in other trials of drugs 30 days before or 90 days after the beginning of this study,
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology, Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, 524000
Yang Zhi gang, +86 13560512702, 13560512702@139.com
Zhi gang Yang
About this study
Official title: Pegylated Liposomal Doxorubicin-contained Versus Daunorubicin-contained VDCLD Regimen in Previously Untreated Adult Patients With Acute Lymphoblastic Leukemia: Complete Remission Rates and Changes of Leukemia Stem Cells
To determine, compared with Daunorubicin(DNR), whether Pegylated liposomal doxorubicin (PLD) inducing higher complete remission (CR) rate, in untreated primary ALL adult patients with VDCLD regimen induction therapy. Second, to determine, compared with the DNR, whether chemotherapy containing PLD with a higher response rates and greater safety in adult ALL
Read the detailed description
This is a prospective, multicenter, open, non-intervention clinical study, with estimated enrollment of 200 newly diagnosed adult ALL patients. After the first course of treatment administered with PLD-contained or DNR-contained VDCLD regimen, CR rate and changes of leukemia stem cells in bone marrow, was evaluated; the safety of these chemotherapy was also evaluated.
Study Patients:
Patients included in this study should be untreated with ALL previously, being in line with the inclusion criteria and exclusion criteria.
Dosage and Administration:
PLD-contained VDCLD regimen：PLD 36 mg/m2 ivdrip over 60 minutes( d1、15),VCR 1.4mg/m iv(d1，8，15，22), CTX 800 mg/m2 ivdrip( d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip (d1～28).
DNR-contained VDCLD regimen：DNR 45 mg/m2 ivdrip over 60 minutes(d1～3),VCR 1.4mg/m2 iv(d1，d8，d15，d22), CTX 800 mg/m2 ivdrip(d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip(d1～28).
Endpoints:
Primary endpoint: The primary endpoint of the study was complete remission (CR) rates after the first course of regimen. The proportion of patients achieved CR was evaluated, after the first course of induction chemotherapy administered with PLD-contained or DNR-contained VDCLD regimen Secondary endpoint: The change of leukemia stem cells in bone marrow, was evaluated before and after administered with PLD-contained or DNR-contained VDCLD regimen.
Safety Assessment:
In order to adjust the treatment strategy and ensure patients' safety effectively, routine blood test, transaminases, and creatinine was monitored on time during the period, while lung CT and ECG was performed based on clinical need. Possible adverse reactions and tolerability during treatment, such as gastrointestinal reactions, cardiac function, as well as discontinuation ratio due to side effects or tolerability of PLD, was recorded.
Statistical Analysis:
All the calculations were performed with the SPSS statistical software. The continuous variables were performed with T test; categorical variables were performed withχ2 test. After acceptance of various observation records sheets, data were unified processed.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- VDCLD regimen
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VDCLD regimenDrug
| Study group | Role | What they receive |
|---|---|---|
| PLD-contained VDCLD regimen | Experimental | PLD 36 mg/m2 ivdrip over 60 minutes( d1、15),VCR 1.4mg/m iv(d1，8，15，22), CTX 800 mg/m2 ivdrip( d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip (d1～28). Receives: Drug: VDCLD regimen |
| DNR-contained VDCLD regimen | Active comparator | DNR 45 mg/m2 ivdrip over 60 minutes(d1～3),VCR 1.4mg/m2 iv(d1，d8，d15，d22), CTX 800 mg/m2 ivdrip(d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip(d1～28). Receives: Drug: VDCLD regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR) rates after the first course of regimen
The primary endpoint of the study was complete remission (CR) rates after the first course of regimen. The proportion of patients achieved CR was evaluated, after the first course of induction chemotherapy administered with PLD-contained or DNR-contained VDCLD regimen
Measured: 3 years after the last enrollment
Secondary outcomes (1)
The change of leukemia stem cells in bone marrow
The change of leukemia stem cells in bone marrow, was evaluated before and after administered with PLD-contained or DNR-contained VDCLD regimen.
Measured: 3 years after the last enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Zhigang Yang, Principal investigator, Affiliated Hospital of Guangdong Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070523
- Sponsor's protocol ID
- ChangzhouJP
- Status last verified
- Feb 2014
- First submitted
- 20 Feb 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegylated Liposomal Doxorubicin-contained Versus Daunorubicin-contained VDCLD Regimen in Previously Untreated Adult Patients With Acute Lymphoblastic Leukemia: Complete Remission Rates and Changes of Leukemia Stem Cells
- ClinicalTrials.gov ID
- NCT02070523
- Acronym / sponsor ID
- ChangzhouJP
- Conditions
- Acute Lymphoblastic Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.University, hospital or other
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Feb 2014 (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 determine, compared with Daunorubicin(DNR), whether Pegylated liposomal doxorubicin (PLD) inducing higher complete remission (CR) rate, in untreated primary ALL adult patients with VDCLD regimen induction therapy. Second, to determine, compared with the DNR, whether chemotherapy containing PLD with a higher response rates and greater safety in adult ALL
Detailed description
This is a prospective, multicenter, open, non-intervention clinical study, with estimated enrollment of 200 newly diagnosed adult ALL patients. After the first course of treatment administered with PLD-contained or DNR-contained VDCLD regimen, CR rate and changes of leukemia stem cells in bone marrow, was evaluated; the safety of these chemotherapy was also evaluated.
Study Patients:
Patients included in this study should be untreated with ALL previously, being in line with the inclusion criteria and exclusion criteria.
Dosage and Administration:
PLD-contained VDCLD regimen：PLD 36 mg/m2 ivdrip over 60 minutes( d1、15),VCR 1.4mg/m iv(d1，8，15，22), CTX 800 mg/m2 ivdrip( d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip (d1～28).
DNR-contained VDCLD regimen：DNR 45 mg/m2 ivdrip over 60 minutes(d1～3),VCR 1.4mg/m2 iv(d1，d8，d15，d22), CTX 800 mg/m2 ivdrip(d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip(d1～28).
Endpoints:
Primary endpoint: The primary endpoint of the study was complete remission (CR) rates after the first course of regimen. The proportion of patients achieved CR was evaluated, after the first course of induction chemotherapy administered with PLD-contained or DNR-contained VDCLD regimen Secondary endpoint: The change of leukemia stem cells in bone marrow, was evaluated before and after administered with PLD-contained or DNR-contained VDCLD regimen.
Safety Assessment:
In order to adjust the treatment strategy and ensure patients' safety effectively, routine blood test, transaminases, and creatinine was monitored on time during the period, while lung CT and ECG was performed based on clinical need. Possible adverse reactions and tolerability during treatment, such as gastrointestinal reactions, cardiac function, as well as discontinuation ratio due to side effects or tolerability of PLD, was recorded.
Statistical Analysis:
All the calculations were performed with the SPSS statistical software. The continuous variables were performed with T test; categorical variables were performed withχ2 test. After acceptance of various observation records sheets, data were unified processed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLD-contained VDCLD regimen | Experimental | Drug: VDCLD regimenPLD 36 mg/m2 ivdrip over 60 minutes( d1、15),VCR 1.4mg/m iv(d1，8，15，22), CTX 800 mg/m2 ivdrip( d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip (d1～28). |
| DNR-contained VDCLD regimen | Active comparator | Drug: VDCLD regimenDNR 45 mg/m2 ivdrip over 60 minutes(d1～3),VCR 1.4mg/m2 iv(d1，d8，d15，d22), CTX 800 mg/m2 ivdrip(d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip(d1～28). |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Eligible men or women were age over 14，but less than 60 years;
- Eastern Cooperative Oncology Group performance status of 0 to2;
- Diagnosed with ALL (WHO classification, the primitive cells ≥ 20%);
- Previous untreated ALL patients had not received chemotherapy before (excluding dexamethasone, prednisone, and hydroxyurea). History of receiving blood transfusion, hematopoietic growth factors, vitamin, and palliative measures such as leukocyte removal, dexamethasone, prednisone, hydroxyurea (0.5-3g daily, more than three days) is allowed;
- The levels of LSCs in bone marrow were measured with flow cytometry before treatment;
Key exclusion criteria (8 listed)
- Mixed type of AL patients;
- Clinically significant active infections;
- Nursing (breastfeeding) or intending to be nursing during the study；
- Pregnancy, or intending to become pregnant during the study;
- Patients with cardiac dysfunction currently (especially congestive heart failure) or history of congestive heart failure;
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 |
|---|---|---|
| VDCLD regimen | Drug | DNR-contained VDCLD regimen, PLD-contained VDCLD regimen |
Primary outcome
Complete remission (CR) rates after the first course of regimen
Time frame: 3 years after the last enrollment
The primary endpoint of the study was complete remission (CR) rates after the first course of regimen. The proportion of patients achieved CR was evaluated, after the first course of induction chemotherapy administered with PLD-contained or DNR-contained VDCLD regimen
1 secondary outcome
The change of leukemia stem cells in bone marrow
Time frame: 3 years after the last enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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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.
Zhigang Yang principal investigator
Affiliated Hospital of Guangdong Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VDCLD regimen in people with Acute Lymphoblastic Leukemia, run by Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd. at 1 site 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 6 inclusion and 8 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Contact Zhi gang Yang (+86 13560512702, 13560512702@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (CR) rates after the first course of regimen (time frame: 3 years after the last enrollment). 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 8 Jul 2014.