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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00096135




Registration number
NCT00096135
Ethics application status
Date submitted
9/11/2004
Date registered
8/11/2004
Date last updated
14/02/2017

Titles & IDs
Public title
Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
Scientific title
Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1= 18 Months)
Secondary ID [1] 0 0
COG-AALL02P2
Secondary ID [2] 0 0
AALL02P2
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
Other interventions - filgrastim
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - cytarabine
Treatment: Drugs - daunorubicin hydrochloride
Treatment: Drugs - dexamethasone
Treatment: Drugs - etoposide
Treatment: Drugs - leucovorin calcium
Treatment: Drugs - mercaptopurine
Treatment: Drugs - methotrexate
Treatment: Drugs - pegaspargase
Treatment: Drugs - therapeutic hydrocortisone
Treatment: Drugs - vincristine sulfate
Treatment: Other - radiation therapy

Experimental: CNS Patients-Treatment (combination chemotherapy) - All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.

Experimental: Testicular Relapse Patients (Combination chemotherapy) - All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.


Other interventions: filgrastim
given subcutaneously (SC)

Treatment: Drugs: cyclophosphamide
IV over 15-30 minutes

Treatment: Drugs: cytarabine
IV over 3 hours twice daily

Treatment: Drugs: daunorubicin hydrochloride
IV over 15 minutes

Treatment: Drugs: dexamethasone
oral twice daily

Treatment: Drugs: etoposide
IV over 1 hour

Treatment: Drugs: leucovorin calcium
rescue IV over 24 hours

Treatment: Drugs: mercaptopurine
oral

Treatment: Drugs: methotrexate
intramuscularly (IM)

Treatment: Drugs: pegaspargase
intramuscularly (IM)

Treatment: Drugs: therapeutic hydrocortisone


Treatment: Drugs: vincristine sulfate
given IV

Treatment: Other: radiation therapy
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.

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

Outcomes
Primary outcome [1] 0 0
Event-free Survival - Monitoring of efficacy results will be performed in comparison with historical results.
Timepoint [1] 0 0
3 years

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Diagnosis of acute lymphoblastic leukemia (ALL)

- B-precursor lineage (T-precursor lineage closed to accrual as of 05/20/10)

- In first bone marrow remission (M1 by morphology) AND duration of first complete
remission = 18 months from time of initial diagnosis

- First isolated CNS and/or testicular relapse

- Isolated CNS relapse, as defined by 1 of the following:

- WBC = 5/mm^3 in cerebrospinal fluid (CSF) with blasts present on cytospin

- Any number of WBC in CSF with immunophenotypic proof of leukemic relapse,
defined by the following:

- Identifiable blasts AND 1 of the following:

- B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples
obtained 4 weeks apart)

- T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive
CSF samples obtained 4 weeks apart) (Closed to accrual as of
05/20/10)

- Isolated testicular relapse, defined as biopsy proven testicular involvement

- No Down syndrome

- No T-cell ALL or T-cell non-Hodgkin lymphoma

- No known optic nerve and/or retinal involvement

PATIENT CHARACTERISTICS:

Age

- 18 months to 29 years at relapse

Performance status

- Karnofsky 30-100% (for patients > 16 years of age) OR

- Lansky 30-100% (for patients = 16 years of age)

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Creatinine adjusted according to age as follows:

- No greater than 0.4 mg/dL (= 5 months)

- No greater than 0.5 mg/dL (6 months -11 months)

- No greater than 0.6 mg/dL (1 year-23 months)

- No greater than 0.8 mg/dL (2 years-5 years)

- No greater than 1.0 mg/dL (6 years-9 years)

- No greater than 1.2 mg/dL (10 years-12 years)

- No greater than 1.4 mg/dL (13 years and over [female])

- No greater than 1.5 mg/dL (13 years to 15 years [male])

- No greater than 1.7 mg/dL (16 years and over [male]) OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular

- Shortening fraction = 27% by echocardiogram OR

- Ejection fraction = 50% by MUGA

Other

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior bone marrow transplantation

Chemotherapy

- Prior total anthracycline dosage = 360 mg/m^2

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No prior systemic therapy for concurrent extramedullary relapse
Minimum age
18 Months
Maximum age
29 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Not Applicable
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
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United States of America
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Alabama
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Arizona
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Connecticut
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Delaware
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Georgia
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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West Virginia
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Wisconsin
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Alberta
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British Columbia
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Manitoba
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Newfoundland and Labrador
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Nova Scotia
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Bern
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Geneva
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Switzerland
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Lausanne

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 work in different ways to stop cancer cells from
dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage
cancer cells. Giving combination chemotherapy together with radiation therapy may kill more
cancer cells.

PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation
therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the
CNS and/or testes.
Trial website
https://clinicaltrials.gov/show/NCT00096135
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Julio C. Barredo, MD
Address 0 0
University of Miami Miller School of Medicine-Sylvester Cancer Center
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

No data has been provided for results reporting
Summary results
Other publications