Acute Lymphoblastic LeukemiaPhase 4NCT00846703
The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia
A Phase 4 study testing 6-mercaptopurine, Methotrexate and 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone in people with Acute Lymphoblastic Leukemia, run by Sun Yat-sen University at 1 site in China.
Trial summary
The Guangdong work group of childhood acute lymphoblastic leukemia (ALL) therapy was set up in October 2002. The investigators treated the childhood ALL with a GZ2002 protocol since the year 2002, and the protocol was mainly derived from the ALLIC-BFM 2002 protocol. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- 6-mercaptopurine, Methotrexate and 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Dec 2018
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cytologically proven acute lymphoblastic leukemia (ALL)
- No relapse of a previously unrecognized ALL
- Patients must meet one of the following risk criteria:
- Standard-risk (SR) group meeting all of the following criteria:
- Blasts < 1,000/μL in peripheral blood (PB) on day 8
- Aged 1 to < 6 years
Show all 19Show fewer
- Initial WBC < 20,000/μL
- M1 (5%) or M2 (≥ 5% to < 25%) blasts in bone marrow on day 15;
- M1 marrow on day 33.
- Intermediate-risk (IR) group meeting all of the following criteria:
- Aged < 1 or ≥ 6 years and/or WBC ≥ 20,000/μL
- Blasts < 1,000/μL in PB on day 8
- M1 or M2 marrow on day 15
- M3 (≥ 25%) marrow on day 15 OR meets SR criteria but M3 marrow on day 15 and *M1 marrow on day 33.
- High-risk (HR) group meeting ≥ 1 of the following criteria:
- Meets IR criteria and M3 marrow on day 15 (not SR and M3 on day 15)
- Blasts ≥ 1,000/μL in PB on day 8
- M2 or M3 marrow on day 33
- Translocation t(9;22) [BCR/ABL+] (Philadelphia chromosome-positive) or t(4;11) [MLL/AF4+].
Who cannot join
- No Down syndrome
- No other major disease that prohibits study treatment (e.g., severe congenital heart disease)
- Not requiring significant therapy modification owing to study therapy associated complications
- No complications due to other interventions
- No one with missing data that are needed for the differential diagnosis, or for selection of the proper therapy arm
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Jianpei Fang, M.D., +8620-81332003, jpfang2005@163.com
Jianpei Fang, M.D.
About this study
Official title: Clinical Study of GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia in Guangdong Province
The Guangdong work group of childhood acute lymphoblastic leukemia (ALL) therapy was set up in October 2002. The investigators treated the childhood ALL with a GZ2002 protocol since the year 2002, and the protocol was mainly derived from the ALLIC-BFM 2002 protocol. After summarizing the last six years' experience, our group revised the GZ2002 ALL protocol in the year 2008, which is named GD-2008 ALL protocol. The diagnosis and classified criteria is according to the ALLIC-BFM 2002 protocol, and the chemotherapy protocol consists all the therapeutic phases as the ALLIC-BFM 2002 protocol prescribed.
Read the detailed description
The modification includes:
- In the induction phase, the agent of dexamethasone 6 mg/m2 is used instead of prednisone after prednisone prophase.
- The phase "CAM" is 2 weeks for SR patients and 4 weeks for IR and HR patients,respectively.
- Both the SR and IR treatments involve the protocol mM /M (8 weeks) in the phase of consolidation. However, the folinic acid rescue starts at 36 hours instead of 42 hours. The type of HR enters the block treatment the same with the BFM protocol.
- There is not randomized study in delayed intensification. The GD-2008 ALL protocol uses the same protocol II with the BFM study.
- The randomized study focus on the phase of maintenance. The maintenance A is the same with the BFM protocol, while the maintenance B consists of 6mp/MTX and VCR/ dexamethasone. The cycle is 8 weeks: VCR at d1, Dexamethasone at d2 to d7, 6mp from d8 to d56, and MTX at d9,d16, d23, d30, d37,d44,d51.
- The GD-2008 ALL protocol for HR patients use the re-blocks and protocol II phases.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- 6-mercaptopurine, Methotrexate, 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone
- 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.
6-mercaptopurine, MethotrexateDrug
Also called For SR and IR patients (Group one)
6-mercaptopurine p.o. qd
Methotrexate p.o. qw
6-mercaptopurine, Methotrexate, Vincristine, DexamethasoneDrug
Also called For SR and IR patients (Group two)
(1)6-mercaptopurine p.o. qd x 7w Methotrexate p.o. qd x 7w
(2)Vincristine qw x 1w Dexamethasone p.o. qd x 7d
Go to (1) and (2)
| Study group | Role | What they receive |
|---|---|---|
| Protocol A (MM) | Active comparator | Not described Receives: Drug: 6-mercaptopurine, Methotrexate |
| Protocol B (MM/VD) | Experimental | Not described Receives: Drug: 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of safety in the treatment protocol
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJul 2008
- Primary completionDec 2013 (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 Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Jianpei Fang, M.D., Study director, Second Affiliated Hospital, Sun Yat-Sen UniversityXuequn Luo, M.D., Principal investigator, First Affiliated Hospital, Sun Yat-Sen UniversityJianliang Chen, M.D., Principal investigator, Third Affiliated Hospital, Sun Yat-Sen UniversityXiaofei Sun, Principal investigator, The cancer hospital of Sun Yat-sen UniversityXuedong Wu, Principal investigator, Nanfang hospital of Nanfang Medical UniversityLiming Tu, M.D., Principal investigator, Guangdong Provincial People's HospitalDongbo Lai, M.D., Principal investigator, Guangzhou children's hospitalChanggang Li, M.D., Principal investigator, Shenzhen Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846703
- Sponsor's protocol ID
- 2007016
- Status last verified
- Mar 2010
- First submitted
- 17 Feb 2009
- Last updated
- 8 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia in Guangdong Province
- ClinicalTrials.gov ID
- NCT00846703
- Acronym / sponsor ID
- 2007016
- Conditions
- Acute Lymphoblastic Leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Feb 2009 (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 Guangdong work group of childhood acute lymphoblastic leukemia (ALL) therapy was set up in October 2002. The investigators treated the childhood ALL with a GZ2002 protocol since the year 2002, and the protocol was mainly derived from the ALLIC-BFM 2002 protocol. After summarizing the last six years' experience, our group revised the GZ2002 ALL protocol in the year 2008, which is named GD-2008 ALL protocol. The diagnosis and classified criteria is according to the ALLIC-BFM 2002 protocol, and the chemotherapy protocol consists all the therapeutic phases as the ALLIC-BFM 2002 protocol prescribed.
Detailed description
The modification includes:
- In the induction phase, the agent of dexamethasone 6 mg/m2 is used instead of prednisone after prednisone prophase.
- The phase "CAM" is 2 weeks for SR patients and 4 weeks for IR and HR patients,respectively.
- Both the SR and IR treatments involve the protocol mM /M (8 weeks) in the phase of consolidation. However, the folinic acid rescue starts at 36 hours instead of 42 hours. The type of HR enters the block treatment the same with the BFM protocol.
- There is not randomized study in delayed intensification. The GD-2008 ALL protocol uses the same protocol II with the BFM study.
- The randomized study focus on the phase of maintenance. The maintenance A is the same with the BFM protocol, while the maintenance B consists of 6mp/MTX and VCR/ dexamethasone. The cycle is 8 weeks: VCR at d1, Dexamethasone at d2 to d7, 6mp from d8 to d56, and MTX at d9,d16, d23, d30, d37,d44,d51.
- The GD-2008 ALL protocol for HR patients use the re-blocks and protocol II phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocol A (MM) | Active comparator | Drug: 6-mercaptopurine, Methotrexate |
| Protocol B (MM/VD) | Experimental | Drug: 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- Cytologically proven acute lymphoblastic leukemia (ALL)
- No relapse of a previously unrecognized ALL
- Patients must meet one of the following risk criteria:
- Standard-risk (SR) group meeting all of the following criteria:
- Blasts < 1,000/μL in peripheral blood (PB) on day 8
Key exclusion criteria (5 listed)
- No Down syndrome
- No other major disease that prohibits study treatment (e.g., severe congenital heart disease)
- Not requiring significant therapy modification owing to study therapy associated complications
- No complications due to other interventions
- No one with missing data that are needed for the differential diagnosis, or for selection of the proper therapy arm
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 |
|---|---|---|
| 6-mercaptopurine, MethotrexateAlso: For SR and IR patients (Group one)6-mercaptopurine p.o. qd Methotrexate p.o. qw | Drug | Protocol A (MM) |
| 6-mercaptopurine, Methotrexate, Vincristine, DexamethasoneAlso: For SR and IR patients (Group two)(1)6-mercaptopurine p.o. qd x 7w Methotrexate p.o. qd x 7w (2)Vincristine qw x 1w Dexamethasone p.o. qd x 7d Go to (1) and (2) | Drug | Protocol B (MM/VD) |
Primary outcome
The improvement of safety in the treatment protocol
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2010.
Related trials for Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Jianpei Fang, M.D. study director
Second Affiliated Hospital, Sun Yat-Sen University
Xuequn Luo, M.D. principal investigator
First Affiliated Hospital, Sun Yat-Sen University
Jianliang Chen, M.D. principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
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 6-mercaptopurine, Methotrexate and 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone in people with Acute Lymphoblastic Leukemia, run by Sun Yat-sen University 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 19 inclusion and 5 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 Mar 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaoliang Huang, M.D. (+8620-81332003, luhong.xu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of safety in the treatment protocol (time frame: Two 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 8 Mar 2010.