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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00022126




Registration number
NCT00022126
Ethics application status
Date submitted
10/08/2001
Date registered
27/01/2003
Date last updated
20/02/2014

Titles & IDs
Public title
Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
Scientific title
A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia
Secondary ID [1] 0 0
COG-AALL01P1
Secondary ID [2] 0 0
AALL01P1
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 - asparaginase
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - cyclosporine
Treatment: Drugs - cytarabine
Treatment: Drugs - daunorubicin hydrochloride
Treatment: Drugs - dexamethasone
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - mercaptopurine
Treatment: Drugs - methotrexate
Treatment: Drugs - methylprednisolone
Treatment: Drugs - pegaspargase
Treatment: Drugs - thioguanine
Treatment: Drugs - vincristine sulfate
Treatment: Surgery - allogeneic bone marrow transplantation
Treatment: Other - radiation therapy

Experimental: Modified Augmented BFM Therapy -


Treatment: Drugs: asparaginase


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: cyclosporine


Treatment: Drugs: cytarabine


Treatment: Drugs: daunorubicin hydrochloride


Treatment: Drugs: dexamethasone


Treatment: Drugs: doxorubicin hydrochloride


Treatment: Drugs: mercaptopurine


Treatment: Drugs: methotrexate


Treatment: Drugs: methylprednisolone


Treatment: Drugs: pegaspargase


Treatment: Drugs: thioguanine


Treatment: Drugs: vincristine sulfate


Treatment: Surgery: allogeneic bone marrow transplantation


Treatment: Other: radiation therapy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Establish whether the CCG Augmented Regimen (AR) can be successfully administered in the infant age group
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Grade 3 or 4 non-hematologic toxicity rates
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Event-free survival
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Diagnosis of previously untreated acute lymphoblastic leukemia (ALL) or acute
undifferentiated leukemia

- CNS or testicular disease allowed

- No L3 sIg+ ALL or acute myelogenous leukemia

- At least 36 weeks gestation for congenital ALL

PATIENT CHARACTERISTICS:

Age:

- Under 366 days at diagnosis

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Steroid therapy within 48 hours of study allowed if complete blood counts and lumbar
puncture results known

- No chronic steroid treatment for other disease

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No other concurrent cytotoxic therapy
Minimum age
No limit
Maximum age
1 Year
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
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
1/11/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2006
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
6006 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 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. Giving the drugs in different combinations may kill more cancer
cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and
kill more cancer cells.

PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or
without donor bone marrow transplantation in treating infants who have previously untreated
acute lymphoblastic leukemia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00022126
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul S. Gaynon, MD
Address 0 0
Children's Hospital Los Angeles
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/NCT00022126