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

NCT00707083 | Completed Phase 3

• 2 other identifiers: POWH-CRE-2008.077-TCDR0000595184
• Study Type: interventional
• Target: 2,231
• Locations: 1 country
• Sites: 2

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.

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemia; childhood acute lymphoblastic leukemia in remission; B-cell childhood acute lymphoblastic leukemia; T-cell childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Bone marrow suppression and liver toxicity

  compare marrow suppression in the two arms of maintenance treatment

  24 or 30 months of chemotherapy

Secondary Outcomes (2)

• overall and event-free survival

  3 years after stop treatment

• Hospitalization rate during maintenance treatment

  24 or 30 months after chemotherapy

Study Arms (2)

Standard- or Intermediate-Risk Maintenance Arm I

ACTIVE COMPARATOR

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; Drug: mercaptopurine; Drug: methotrexate; Drug: vincristine sulfate

Standard- or Intermediate-Risk Maintenance Arm II

EXPERIMENTAL

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; Drug: mercaptopurine; Drug: methotrexate; Drug: vincristine sulfate

Interventions

dexamethasone DRUG

Given oral

Standard- or Intermediate-Risk Maintenance Arm I; Standard- or Intermediate-Risk Maintenance Arm II

mercaptopurine DRUG

Given orally

Standard- or Intermediate-Risk Maintenance Arm I; Standard- or Intermediate-Risk Maintenance Arm II

methotrexate DRUG

Given orally

Standard- or Intermediate-Risk Maintenance Arm I; Standard- or Intermediate-Risk Maintenance Arm II

vincristine sulfate DRUG

Given IV

Standard- or Intermediate-Risk Maintenance Arm I; Standard- or Intermediate-Risk Maintenance Arm II

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong: lead

Study Sites (2)

Prince of Wales Hospital

Hong Kong, China

Location

Queen Mary Hospital - Hong Kong

Hong Kong, China

Location

Related Publications (1)

• Liu X, Zou Y, Chen X, Wang S, Guo Y, Yang W, Zhang L, Chen Y, Zhang Y, Zhu X. Minimal residual disease surveillance at day 90 predicts long-term survival in pediatric patients with T-cell acute lymphoblastic leukemia. Leuk Lymphoma. 2020 Dec;61(14):3460-3467. doi: 10.1080/10428194.2020.1805739. Epub 2020 Aug 11.

  PMID: 32779947 DERIVED

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Leukemia

Interventions

Dexamethasone; Mercaptopurine; Methotrexate; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Chi-Kong Li, MD

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: June 30, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2018
• Study Completion: March 1, 2020
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)