Acute Lymphoblastic LeukemiaPhase 4NCT01358253
Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia
A Phase 4 study testing Cyclophosphamide, Doxorubicin and Vincristine in people with Acute Lymphoblastic Leukemia, run by Ruijin Hospital at 1 site in China.
Trial summary
The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined with chemotherapy in CD20+ adult acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Cyclophosphamide, Doxorubicin and Vincristine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Dec 2012
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of CD20-positive ALL
- Adequate liver function (bilirubin less than or equal to 1.5*ULN, unless considered due to tumor), and renal function (creatinine less than or equal to 1.5*ULN, unless considered due to tumor)
- Signed informed consent
Who cannot join
- Prior history of treatment with high-dose Ara-C, MTX or rituximab
- Pregnant or lactating women
- History of allergy to rituximab
- Unable to sign informed consent
- Active replication of HBV
- History of stem cell transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Rituximab Combined With Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia
The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined with chemotherapy in CD20+ adult acute lymphoblastic leukemia.
Read the detailed description
Acute lymphoblastic leukemia (ALL) is a group of biologically heterogeneous diseases with diverse prognosis. Novel strategies for adult ALL have approached a CR rate of over 80%, which is similar to pediatric ALL. But the long term survival of adult ALL is only 30%-40%, much lower than pediatric patients.
In our trial, all the patients will first receive Vincristine 1.4mg/m2, max 2mg IV days 1,8,15,22, Daunorubicin 45mg/m2 IV days 1-3,Cyclophosphamide 750mg/m2 IV day 1 and prednisone 40-60mg/m2,by mouth days 1-14 (VDCP)regimen as initial induction therapy. If patients achieve complete remission after induction, they will be enrolled in our study for further consolidation and maintenance. If the tumor cells in bone marrow remain 5% to 20% after induction, the patients will receive VDCLP(VDCP+L-asparaginase 6000IU/m2 IV days5,7,9,11,13) and be enrolled until complete remission.
Rituximab is the main experimental intervention in our study.The consolidation regimen is HyperCVAD/MA or R-HyperCVAD/MA for totally 8 courses. The maintenance regimen includes 6-Mercaptopurine+Methotrexate for 24 months, Vincristine+Prednisone for the first 12 months, L-asparaginase in month 3 and 9 with or without Rituximab in month 6 and 12.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone, Cytarabine
- Keywords
- Rituximab, HyperCVAD
- 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.
CyclophosphamideDrug
300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2)(odd courses).
DoxorubicinDrug
50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).
VincristineDrug
Consolidation:1.4 mg/m2 (max 2mg) IV on day 4 and day 11 (odd courses). Maintenance:1.4mg/m2(max 2mg) IV monthly from 1st to 12th month.
DexamethasoneDrug
40mg IV or by mouth (P.O.) daily days 1-4 and days 11-14(odd courses)
CytarabineDrug
2g/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).
MethotrexateDrug
Consolidation:1000 mg/m2 IV over 24 hours on day 1 (even courses). Maintenance:25mg/m2 weekly for 24 months.
RituximabDrug
Consolidation:375 mg/m2 IV day 1 for the odd courses of therapy (total 4 times).
Maintenance:375 mg/m2 IV in 6th month and 12th month.
6-MercaptopurineDrug
Maintenance:60mg/m2 daily for 24 months.
PrednisoneDrug
Maintenance:40mg/m2 from days 1-7 monthly from 1st to 12th month.
L-asparaginaseDrug
Maintenance:6000IU/m2 IV on days 1,3,5 of the 3rd and 9th month.
| Study group | Role | What they receive |
|---|---|---|
| HyperCVAD | Active comparator | Consolidation:
HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses.
Maintenance:
6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Dexamethasone; Drug: Cytarabine; Drug: Methotrexate; Drug: 6-Mercaptopurine; Drug: Prednisone; Drug: L-asparaginase |
| R-HyperCVAD | Experimental | Consolidation:
R-HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses.
Maintenance:
6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9. Rituximab in month 6 and 12. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Dexamethasone; Drug: Cytarabine; Drug: Methotrexate; Drug: Rituximab; Drug: 6-Mercaptopurine; Drug: Prednisone; Drug: L-asparaginase |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR duration
Bone marrow MRD examination every two months
Measured: After two 21-day courses
disease free survival
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2012
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.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Weili Zhao, MD,PhD, Principal investigator, Department of hematology Ruijin Hospital/Shanghai Institute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358253
- Sponsor's protocol ID
- RJ-2010-56
- Status last verified
- May 2011
- First submitted
- 18 May 2011
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Rituximab Combined With Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT01358253
- Acronym / sponsor ID
- RJ-2010-56
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Rituximab, HyperCVAD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 May 2011 (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.
The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined with chemotherapy in CD20+ adult acute lymphoblastic leukemia.
Detailed description
Acute lymphoblastic leukemia (ALL) is a group of biologically heterogeneous diseases with diverse prognosis. Novel strategies for adult ALL have approached a CR rate of over 80%, which is similar to pediatric ALL. But the long term survival of adult ALL is only 30%-40%, much lower than pediatric patients.
In our trial, all the patients will first receive Vincristine 1.4mg/m2, max 2mg IV days 1,8,15,22, Daunorubicin 45mg/m2 IV days 1-3,Cyclophosphamide 750mg/m2 IV day 1 and prednisone 40-60mg/m2,by mouth days 1-14 (VDCP)regimen as initial induction therapy. If patients achieve complete remission after induction, they will be enrolled in our study for further consolidation and maintenance. If the tumor cells in bone marrow remain 5% to 20% after induction, the patients will receive VDCLP(VDCP+L-asparaginase 6000IU/m2 IV days5,7,9,11,13) and be enrolled until complete remission.
Rituximab is the main experimental intervention in our study.The consolidation regimen is HyperCVAD/MA or R-HyperCVAD/MA for totally 8 courses. The maintenance regimen includes 6-Mercaptopurine+Methotrexate for 24 months, Vincristine+Prednisone for the first 12 months, L-asparaginase in month 3 and 9 with or without Rituximab in month 6 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HyperCVAD | Active comparator | Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Dexamethasone, Drug: Cytarabine, Drug: Methotrexate, Drug: 6-Mercaptopurine, Drug: Prednisone, Drug: L-asparaginaseConsolidation: HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Maintenance: 6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9. |
| R-HyperCVAD | Experimental | Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Dexamethasone, Drug: Cytarabine, Drug: Methotrexate, Drug: Rituximab, Drug: 6-Mercaptopurine, Drug: Prednisone, Drug: L-asparaginaseConsolidation: R-HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Maintenance: 6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9. Rituximab in month 6 and 12. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of CD20-positive ALL
- Adequate liver function (bilirubin less than or equal to 1.5*ULN, unless considered due to tumor), and renal function (creatinine less than or equal to 1.5*ULN, unless considered due to tumor)
- Signed informed consent
Key exclusion criteria (6 listed)
- Prior history of treatment with high-dose Ara-C, MTX or rituximab
- Pregnant or lactating women
- History of allergy to rituximab
- Unable to sign informed consent
- Active replication of HBV
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 |
|---|---|---|
| Cyclophosphamide300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2)(odd courses). | Drug | HyperCVAD, R-HyperCVAD |
| Doxorubicin50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). | Drug | HyperCVAD, R-HyperCVAD |
| VincristineConsolidation:1.4 mg/m2 (max 2mg) IV on day 4 and day 11 (odd courses). Maintenance:1.4mg/m2(max 2mg) IV monthly from 1st to 12th month. | Drug | HyperCVAD, R-HyperCVAD |
| Dexamethasone40mg IV or by mouth (P.O.) daily days 1-4 and days 11-14(odd courses) | Drug | HyperCVAD, R-HyperCVAD |
| Cytarabine2g/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses). | Drug | HyperCVAD, R-HyperCVAD |
| MethotrexateConsolidation:1000 mg/m2 IV over 24 hours on day 1 (even courses). Maintenance:25mg/m2 weekly for 24 months. | Drug | HyperCVAD, R-HyperCVAD |
| RituximabConsolidation:375 mg/m2 IV day 1 for the odd courses of therapy (total 4 times). Maintenance:375 mg/m2 IV in 6th month and 12th month. | Drug | R-HyperCVAD |
| 6-MercaptopurineMaintenance:60mg/m2 daily for 24 months. | Drug | HyperCVAD, R-HyperCVAD |
| PrednisoneMaintenance:40mg/m2 from days 1-7 monthly from 1st to 12th month. | Drug | HyperCVAD, R-HyperCVAD |
| L-asparaginaseMaintenance:6000IU/m2 IV on days 1,3,5 of the 3rd and 9th month. | Drug | HyperCVAD, R-HyperCVAD |
Primary outcome
CR duration
Time frame: After two 21-day courses
Bone marrow MRD examination every two months
disease free survival
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 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.
Weili Zhao, MD,PhD principal investigator
Department of hematology Ruijin Hospital/Shanghai Institute of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclophosphamide, Doxorubicin and Vincristine in people with Acute Lymphoblastic Leukemia, run by Ruijin Hospital 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 20 May 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CR duration (time frame: After two 21-day courses). The study lists 2 primary outcomes in all. 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 20 May 2014.