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The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia

Primary Purpose

Acute Lymphoblastic Leukemia

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

6-mercaptopurine, Methotrexate

6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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+].

Exclusion Criteria:

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

Sites / Locations

The second affiliated hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Protocol A (MM)

Protocol B (MM/VD)

Arm Description

Outcomes

Primary Outcome Measures

The improvement of safety in the treatment protocol

Secondary Outcome Measures

Full Information

NCT ID

NCT00846703

First Posted

February 17, 2009

Last Updated

March 5, 2010

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT00846703

Brief Title

The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia

Official Title

Clinical Study of GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia in Guangdong Province

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Unknown status

Study Start Date

July 2008 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Protocol A (MM)

Arm Type

Active Comparator

Arm Title

Protocol B (MM/VD)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

6-mercaptopurine, Methotrexate

Other Intervention Name(s)

For SR and IR patients (Group one)

Intervention Description

6-mercaptopurine p.o. qd Methotrexate p.o. qw

Intervention Type

Drug

Intervention Name(s)

6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone

Other Intervention Name(s)

For SR and IR patients (Group two)

Intervention Description

(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)

Primary Outcome Measure Information:

Title

The improvement of safety in the treatment protocol

Time Frame

Two months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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+]. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shaoliang Huang, M.D.

Phone

+8620-81332003

luhong.xu@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianpei Fang, M.D.

Organizational Affiliation

Second Affiliated Hospital, Sun Yat-Sen University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Xuequn Luo, M.D.

Organizational Affiliation

First Affiliated Hospital, Sun Yat-Sen University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jianliang Chen, M.D.

Organizational Affiliation

Third Affiliated Hospital, Sun Yat-Sen University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiaofei Sun

Organizational Affiliation

The cancer hospital of Sun Yat-sen University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xuedong Wu

Organizational Affiliation

Nanfang hospital of Nanfang Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Liming Tu, M.D.

Organizational Affiliation

Guangdong Provincial People's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dongbo Lai, M.D.

Organizational Affiliation

Guangzhou children's hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Changgang Li, M.D.

Organizational Affiliation

Shenzhen Children's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Liyang Liu, M.D.

Organizational Affiliation

Huizhou People's Central Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The second affiliated hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianpei Fang, M.D.

Phone

+8620-81332003

jpfang2005@163.com

First Name & Middle Initial & Last Name & Degree

Jianpei Fang, M.D.

12. IPD Sharing Statement

Learn more about this trial

The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia

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