Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00967057
First received: August 26, 2009
Last updated: August 9, 2013
Last verified: January 2011
  Purpose

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. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia.

PURPOSE: This partially randomized phase III trial is studying how well combination chemotherapy works in treating young patients with relapsed or refractory acute lymphoblastic leukemia.


Condition Intervention Phase
Leukemia
Drug: asparaginase
Drug: dexamethasone
Drug: idarubicin
Drug: methotrexate
Drug: mitoxantrone hydrochloride
Drug: pegaspargase
Drug: vincristine sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: ALLR3: An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival (PFS) of United Kingdom (UK) patients stratified by risk groups [ Designated as safety issue: No ]
  • Evaluation of whether a minimal residual disease (MRD) level of 10(-4) is a suitable criterion at the end of induction therapy on which to decide whether chemotherapy or stem cell transplantation will be most beneficial to patients with intermediate- ... [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRD as a surrogate marker for treatment response and PFS [ Designated as safety issue: No ]
  • Comparison of PFS, MRD level at day 35, and toxicity as response variables in patients randomized to receive induction therapy with mitoxantrone hydrochloride or idarubicin [ Designated as safety issue: No ]
  • PFS of all patients (UK, Dutch, Australian, and New Zealand) stratified by risk groups [ Designated as safety issue: No ]
  • Comparison of PFS and overall survival between patients enrolled in this study and patients enrolled in R2 or I-BFM [ Designated as safety issue: No ]
  • Evaluation of whether pre-stem cell transplantation cytoreduction (FLAD) reduces tumor load and how it affects outcome following transplant [ Designated as safety issue: No ]

Estimated Enrollment: 470
Study Start Date: October 2002
Study Completion Date: December 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (induction therapy)
Patients receive idarubicin IV over 1 hour on days 1 and 2; oral dexamethasone twice daily on days 1-5 and 15-19; intrathecal (IT) methotrexate on days 1 and 8; vincristine sulfate IV on days 3, 10, 17, and 24; and pegaspargase intramuscularly (IM) on days 3 and 17 or asparaginase IM on days 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25.
Drug: asparaginase
Given intramuscularly
Drug: dexamethasone
Given orally
Drug: idarubicin
Given IV
Drug: methotrexate
Given intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: vincristine sulfate
Given IV
Experimental: Arm II (induction therapy)
Patients receive mitoxantrone IV over 1 hour on days 1 and 2. Patients also receive dexamethasone, methotrexate, vincristine sulfate, and pegaspargase or asparaginase as in arm I.
Drug: asparaginase
Given intramuscularly
Drug: dexamethasone
Given orally
Drug: methotrexate
Given intrathecally
Drug: mitoxantrone hydrochloride
Given IV
Drug: pegaspargase
Given intramuscularly
Drug: vincristine sulfate
Given IV

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:

    • In first relapse after treatment

      • Has not yet received chemotherapy or radiotherapy for the first relapse
    • Primary refractory disease
  • No mature B-cell ALL
  • Meets criteria for one of the following risk groups:

    • Standard-risk disease: non-T-cell or T-cell ALL with late isolated extramedullary relapse
    • Intermediate-risk disease: non-T-cell ALL with early isolated extramedullary relapse or combined marrow and extramedullary relapse; non-T-cell ALL with late combined marrow and extramedullary relapse or isolated marrow relapse; or T-cell ALL with early isolated extramedullary relapse
    • High-risk disease: non-T-cell ALL with very early isolated extramedullary relapse, combined marrow and extramedullary relapse, or isolated marrow relapse; non-T-cell ALL with early isolated marrow relapse; T-cell ALL with very early isolated extramedullary relapse, combined marrow and extramedullary relapse, or isolated marrow relapse; T-cell ALL with early combined marrow and extramedullary relapse or isolated marrow relapse; or T-cell ALL with late combined marrow and extramedullary relapse or isolated marrow relapse

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior bone marrow transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967057

Locations
Australia, South Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Bristol Royal Hospital for Children
Bristol, England, United Kingdom, BS2 8BJ
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Principal Investigator: Vaskar Saha, MD Christie Hospital NHS Foundation Trust
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00967057     History of Changes
Other Study ID Numbers: CCLG-ALLR3, CDR0000642221, ISCRTN45724312, EUDRACT-2004-000052-16, EU-20938
Study First Received: August 26, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Asparaginase
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Idarubicin
Methotrexate
Mitoxantrone
Pegaspargase
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Analgesics
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on October 23, 2014