Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00002816




Registration number
NCT00002816
Ethics application status
Date submitted
1/11/1999
Date registered
23/06/2004
Date last updated
22/08/2013

Titles & IDs
Public title
Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia
Scientific title
EXTRAMEDULLARY RELAPSE AND OCCULT BONE MARROW INVOLVEMENT IN CHILDHOOD ACUTE LYMPHOBLASTIC LEUKEMIA: A PHASE III GROUP-WIDE STUDY
Secondary ID [1] 0 0
CCG-1951
Secondary ID [2] 0 0
1951
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cytarabine
Treatment: Drugs - dexamethasone
Treatment: Drugs - etoposide
Treatment: Drugs - idarubicin
Treatment: Drugs - ifosfamide
Treatment: Drugs - leucovorin calcium
Treatment: Drugs - mesna
Treatment: Drugs - pegaspargase
Treatment: Drugs - therapeutic hydrocortisone
Treatment: Drugs - thioguanine
Treatment: Drugs - vincristine sulfate
Treatment: Other - low-LET cobalt-60 gamma ray therapy
Treatment: Other - low-LET electron therapy
Treatment: Other - low-LET photon therapy
Treatment: Drugs - Methotrexate

Experimental: EARLY # CNS RELAPSE with BM DONOR - Induction (Etoposide, Ifosfamide with Mesna Uroprotection,Ifosfamide, Dexamethasone, Vincristine sulfate, PEG, ITT (methotrexate, cytosine arabinoside and therapeutic hydrocortisone), and leucovorin calcium then Intensification (4 courses of 6 weeks, ITT, dexamethasone, vincristine, methotrexate, leucovorin, 6-Thioguanine, cytarabine (Ara-C), Etoposide, pegaspargase, Ifosfamide with Mesna) and Idarubicin and CXRT.

Experimental: LATE CNS RELAPSE with/without BM DONOR, TESTICULAR or OCULAR - Induction (Etoposide, Ifosfamide with Mesna Uroprotection,Ifosfamide, Dexamethasone, Vincristine sulfate, pegaspargase, ITT (methotrexate, cytosine arabinoside and therapeutic hydrocortisone), and leucovorin calcium then Intensification (4 courses of 6 weeks, ITT, dexamethasone, vincristine, methotrexate, leucovorin, 6-Thioguanine, cytarabine (Ara-C), Etoposide, PEG, Ifosfamide with Mesna) and Idarubicin), and Maintenance (4 x 12 courses) of ITT, Vincristine, Methotrexate, T-thioguanine.


Treatment: Drugs: cytarabine
Given IV

Treatment: Drugs: dexamethasone
Given IV

Treatment: Drugs: etoposide
Given IV

Treatment: Drugs: idarubicin
Given IV

Treatment: Drugs: ifosfamide
Given IV

Treatment: Drugs: leucovorin calcium


Treatment: Drugs: mesna
Given IV

Treatment: Drugs: pegaspargase
Given IV

Treatment: Drugs: therapeutic hydrocortisone


Treatment: Drugs: thioguanine


Treatment: Drugs: vincristine sulfate
Given IV

Treatment: Other: low-LET cobalt-60 gamma ray therapy


Treatment: Other: low-LET electron therapy


Treatment: Other: low-LET photon therapy


Treatment: Drugs: Methotrexate
Given IV
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Acute lymphoblastic leukemia (ALL) with isolated extramedullary
relapse Relapse occurred during or following front-line therapy for ALL Initial diagnosis
of more than 25% blasts of L1 or L2 morphology No leukemic marrow (M1) by conventional
assessment Patients with B precursor ALL must also be enrolled on study CCG-B958 Relapse
occurred in the CNS, testis, or eye Ocular relapse confirmed by an ophthalmologist and by
cytology or iris biopsy Combined CNS and ocular relapse eligible Down Syndrome patients not
eligible No prior bone marrow transplantation in first remission No prior toxicity from any
study drugs Patient age: Under 21

PATIENT CHARACTERISTICS: See General Eligibility Criteria
Minimum age
No limit
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2006
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Nova Scotia

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.

PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy in treating
children who have relapsed acute lymphoblastic leukemia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00002816
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael L.N. Willoughby, MD
Address 0 0
Princess Margaret Hospital for Children
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00002816