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Two Combination Chemotherapy Regimens in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00707083
Recruitment Status : Active, not recruiting
First Posted : June 30, 2008
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Chi Kong Li, Prince of Wales Hospital, Shatin, Hong Kong

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

PURPOSE: This randomized clinical trial is studying the side effects of two combination chemotherapy regimens and to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Drug: dexamethasone Drug: mercaptopurine Drug: methotrexate Drug: vincristine sulfate Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Study of Treatment Protocol for Childhood Acute Lymphoblastic Leukemia in China, 2008.
Actual Study Start Date : May 1, 2008
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Active Comparator: Standard- or Intermediate-Risk Maintenance Arm I
Patients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 (girls)-11 (boys) courses.
Drug: dexamethasone
Given oral

Drug: mercaptopurine
Given orally

Drug: methotrexate
Given orally

Drug: vincristine sulfate
Given IV

Experimental: Standard- or Intermediate-Risk Maintenance Arm II
Patients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses.
Drug: dexamethasone
Given oral

Drug: mercaptopurine
Given orally

Drug: methotrexate
Given orally

Drug: vincristine sulfate
Given IV




Primary Outcome Measures :
  1. Bone marrow suppression and liver toxicity [ Time Frame: 24 or 30 months of chemotherapy ]
    compare marrow suppression in the two arms of maintenance treatment


Secondary Outcome Measures :
  1. overall and event-free survival [ Time Frame: 3 years after stop treatment ]
  2. Hospitalization rate during maintenance treatment [ Time Frame: 24 or 30 months after chemotherapy ]


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute lymphoblastic leukemia meeting 1 of the following risk definitions:

    • Standard-risk disease:

      • Age 1 to 9 years
      • White blood cell (WBC) < 50/mm^3 OR t(12;21) or molecular fusion product -positive disease
      • Good response to prior prednisone (day 8 peripheral blood blast < 1,000/mm^3)
      • None of the following subtypes:

        • T-cell
        • t(9;22)
        • t(4;11)
        • t(1;19)
        • Molecular
      • Bone marrow (BM) M1 or M2 on day 15, BM remission (< 5% blast) on day 33
    • Intermediate-risk disease:

      • Good response to prior prednisone
      • BM M1/M2 on day 15
      • Meets 1 of the following criteria:

        • At least 10 years old
        • WBC > 50/mm^3
        • Under 1 year old without Mixed Lineage Leukemia (MLL) gene rearrangement
        • T-cell OR t(1;19) or molecular fusion product positive.
        • Standard-risk patient with BM M3 on day 15
        • If minimal residual disease (MRD) available, day 33 MRD < 10^-2
    • High-risk disease, meeting 1 of the following criteria:

      • Poor response to prior prednisone
      • t(9;22) or molecular fusion product (BCR/ABL1), t(4;11) or molecular fusion product (MLL/AF4)
      • Intermediate-risk patient with BM M3 on day 15
      • BM M2/M3 on day 33
      • If MRD available, flow cytometry/polymerase chain reaction (PCR) > 10% on days 15 OR MRD > 10^-2 on day 33 OR MRD (before mini-M phase or M phase) > 10^-3 on day 84

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707083


Locations
China
Prince of Wales Hospital
Hong Kong, China
Queen Mary Hospital - Hong Kong
Hong Kong, China
Sponsors and Collaborators
Prince of Wales Hospital, Shatin, Hong Kong
Investigators
Principal Investigator: Chi-Kong Li, MD Prince of Wales Hospital

Additional Information:
Responsible Party: Chi Kong Li, Dr., Prince of Wales Hospital, Shatin, Hong Kong
ClinicalTrials.gov Identifier: NCT00707083     History of Changes
Other Study ID Numbers: POWH-CRE-2008.077-T
CDR0000595184 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 30, 2008    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chi Kong Li, Prince of Wales Hospital, Shatin, Hong Kong:
untreated childhood acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia in remission
B-cell childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Methotrexate
Vincristine
6-Mercaptopurine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal