Trial Review

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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/NCT00002805




Registration number
NCT00002805
Ethics application status
Date submitted
1/11/1999
Date registered
2/09/2004
Date last updated
24/07/2014

Titles & IDs
Public title
Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Scientific title
Acute Myeloid Leukemia Salvage Therapy for Patients in First Relapse or Who Fail to Achieve an Initial Remission or Who Develop AML as a Second Malignant Neoplasm
Secondary ID [1] 0 0
CCG-2951
Secondary ID [2] 0 0
2951
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
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - filgrastim
Treatment: Drugs - cladribine
Treatment: Drugs - cytarabine
Treatment: Drugs - etoposide
Treatment: Drugs - methotrexate
Treatment: Drugs - mitoxantrone hydrochloride
Treatment: Drugs - therapeutic hydrocortisone
Treatment: Surgery - allogeneic bone marrow transplantation
Treatment: Surgery - autologous bone marrow transplantation
Treatment: Surgery - peripheral blood stem cell transplantation
Treatment: Other - low-LET cobalt-60 gamma ray therapy
Treatment: Other - low-LET electron therapy
Treatment: Other - low-LET photon therapy

Experimental: Treatment - Induction will consist of one course of cytarabine and mitoxantrone. Patients achieving a complete or partial response by the end of induction will start intensification. Intensification will consist of one course of chemotherapy (Cytarabine (Ara-C), Etoposide (VP-16), Filgrastim (G-CSF)). Patients who do not attain a CNS remission following the completion of intensification therapy, or who develop recurrence of CNS disease and have not previously received radiation therapy involving the central nervous system should receive craniospinal radiotherapy. Continuation Therapy: cladribine (2CdA), Etoposide.


Other interventions: filgrastim


Treatment: Drugs: cladribine


Treatment: Drugs: cytarabine


Treatment: Drugs: etoposide


Treatment: Drugs: methotrexate


Treatment: Drugs: mitoxantrone hydrochloride


Treatment: Drugs: therapeutic hydrocortisone


Treatment: Surgery: allogeneic bone marrow transplantation


Treatment: Surgery: autologous bone marrow transplantation


Treatment: Surgery: peripheral blood stem cell transplantation


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


Treatment: Other: low-LET electron therapy


Treatment: Other: low-LET photon therapy
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Intervention code [4] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Estimate second remission rate and survival rate
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Evaluate the mortality of the start of VP-16/Ara-C intensification
Timepoint [1] 0 0
45 days
Secondary outcome [2] 0 0
Compare outcomes by the ethnicity and gender
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) or myelodysplastic syndrome in one of
the following categories: In first relapse Failed to achieve initial complete remission
Newly diagnosed secondary AML eligible Required bone marrow status: Greater than 25% blasts
(M3) OR Persistent abnormal clone on cytogenetics and 5-25% blasts (M2) No Fanconi's anemia

PATIENT CHARACTERISTICS: Age: Under 22 Performance status: Not specified Hematopoietic: See
Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times normal AST or ALT less
than 4.0 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine
clearance or GFR greater than 70 mL/min per 1.73 square meters or GFR in equivalent
institutional normal range Cardiovascular: Shortening fraction greater than 27% by
echocardiogram or in institutional normal range OR Ejection fraction greater than 47% by
radionuclide angiogram

PRIOR CONCURRENT THERAPY: No more than 1 prior treatment No prior salvage therapy No prior
mitoxantrone
Minimum age
No limit
Maximum age
21 Years
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
1/08/1997
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
115
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 Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
North Dakota
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 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. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did
not achieve first remission.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00002805
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert J. Wells, MD
Address 0 0
Children's Hospital Medical Center, Cincinnati
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/NCT00002805