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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01026220




Registration number
NCT01026220
Ethics application status
Date submitted
3/12/2009
Date registered
4/12/2009
Date last updated
28/04/2022

Titles & IDs
Public title
Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
Scientific title
A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma
Secondary ID [1] 0 0
NCI-2011-01994
Secondary ID [2] 0 0
AHOD0831
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma 0 0
Stage III Childhood Hodgkin Lymphoma 0 0
Stage IV Childhood Hodgkin Lymphoma 0 0
Condition category
Condition code
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
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - bleomycin sulfate
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - liposomal vincristine sulfate
Treatment: Drugs - vinorelbine tartrate
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - etoposide phosphate
Treatment: Drugs - prednisone
Treatment: Other - filgrastim
Treatment: Drugs - ifosfamide

Experimental: Regimen I (consolidation therapy) - Patients receive 2 more courses of ABVE-PC comprising doxorubicin hydrochloride IV over 1-120 minutes and cyclophosphamide IV over 30-60 minutes on days 1 and 2; bleomycin sulfate IV over at least 10 minutes or subcutaneously (SC) and vincristine sulfate IV on days 1 and 8; etoposide IV over 1-2 hours on days 1-3; oral prednisone twice daily on days 1-7; and filgrastim SC or IV daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression.

Experimental: Regimen II (consolidation therapy) - Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1 and 5, and filgrastim SC or IV beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.

Experimental: Induction: all patient - All patients receive ABVE-PC induction therapy then they are assigned to Group 2 (RER), Group 3 (SER) or taken off study if they develop progressive disease.


Treatment: Other: bleomycin sulfate
Given IV or SC

Treatment: Drugs: doxorubicin hydrochloride
Given IV

Treatment: Drugs: liposomal vincristine sulfate
Given IV

Treatment: Drugs: vinorelbine tartrate
Given IV

Treatment: Drugs: cyclophosphamide
Given IV

Treatment: Drugs: etoposide phosphate
Given IV

Treatment: Drugs: prednisone
Given IV

Treatment: Other: filgrastim
Given IV or SC

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

Outcomes
Primary outcome [1] 0 0
Second-event-free Survival
Timepoint [1] 0 0
At 4 years from enrollment
Primary outcome [2] 0 0
Safety Analysis and Monitoring of Toxic Death
Timepoint [2] 0 0
Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).
Secondary outcome [1] 0 0
Event Free Survival
Timepoint [1] 0 0
At 3 years from enrollment
Secondary outcome [2] 0 0
Second-event-free Survival
Timepoint [2] 0 0
At 4 years from enrollment
Secondary outcome [3] 0 0
Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative
Timepoint [3] 0 0
3 years from enrollment
Secondary outcome [4] 0 0
Relapse-free Survival
Timepoint [4] 0 0
3 years from enrollment
Secondary outcome [5] 0 0
Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy
Timepoint [5] 0 0
During and after completion of study treatment.
Secondary outcome [6] 0 0
Overall Survival
Timepoint [6] 0 0
At 3 years from enrollment

Eligibility
Key inclusion criteria
* Pathologically confirmed newly diagnosed Hodgkin lymphoma (HL) meeting one of the following criteria:

* Classical disease
* Nodular lymphocyte-predominant disease
* Stage III or IV disease with B symptoms, as defined by = 1 of the following:

* Unexplained weight loss > 10% within the past 6 months
* Unexplained recurrent fever > 38°C within the past month
* Recurrent drenching night sweats within the past month
* Creatinine clearance or radioisotope GFR = 70 mL/min OR maximum serum creatinine based on age/gender as follows:

* 0.4 mg/dL (1 to 5 months)
* 0.5 mg/dL (6 to 11 months)
* 0.6 mg/dL (12 to 23 months)
* 0.8 mg/dL (2 to 5 years)
* 1 mg/dL (6 to 9 years)
* 1.2 mg/dL (10 to 12 years)
* 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years)
* 1.7 mg/dL (males) or 1.4 mg/dL (females) (= 16 years)
* Total bilirubin = 1.5 times upper limit of normal (ULN) for age
* AST or ALT < 2.5 times ULN for age
* Shortening fraction = 27% by ECHO OR ejection fraction = 50% by MUGA (unless due to large mediastinal mass from HL)
* FEV_1/FVC > 60% by pulmonary function tests (PFT) (unless due to large mediastinal mass fromHL)

* For children who are unable to cooperate for PFTs, the criteria are:

* No evidence of dyspnea at rest
* No exercise intolerance
* Pulse oximetry > 92% on room air
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pathologic prolongation of QTc interval (> 450 milliseconds) on 12-lead ECG
* No prior chemotherapy, biological response modifiers (e.g., monoclonal antibody therapy), or radiotherapy
* At least 28 days since prior corticosteroids except for emergent treatment for respiratory distress or spinal cord compression, or for treatment of allergy to contrast agent required for CT scan
* No other concurrent cancer chemotherapy or immunomodulating agents (including steroids)

* Concurrent corticosteroid therapy as treatment or prophylaxis for anaphylactic reactions allowed
* No concurrent pegfilgrastim
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
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
Parallel
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
7/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2022
Sample size
Target
Accrual to date
Final
166
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [4] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [5] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Hawaii
Country [12] 0 0
United States of America
State/province [12] 0 0
Idaho
Country [13] 0 0
United States of America
State/province [13] 0 0
Illinois
Country [14] 0 0
United States of America
State/province [14] 0 0
Indiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Iowa
Country [16] 0 0
United States of America
State/province [16] 0 0
Kentucky
Country [17] 0 0
United States of America
State/province [17] 0 0
Louisiana
Country [18] 0 0
United States of America
State/province [18] 0 0
Maryland
Country [19] 0 0
United States of America
State/province [19] 0 0
Massachusetts
Country [20] 0 0
United States of America
State/province [20] 0 0
Michigan
Country [21] 0 0
United States of America
State/province [21] 0 0
Minnesota
Country [22] 0 0
United States of America
State/province [22] 0 0
Mississippi
Country [23] 0 0
United States of America
State/province [23] 0 0
Missouri
Country [24] 0 0
United States of America
State/province [24] 0 0
Nebraska
Country [25] 0 0
United States of America
State/province [25] 0 0
Nevada
Country [26] 0 0
United States of America
State/province [26] 0 0
New Hampshire
Country [27] 0 0
United States of America
State/province [27] 0 0
New Jersey
Country [28] 0 0
United States of America
State/province [28] 0 0
New Mexico
Country [29] 0 0
United States of America
State/province [29] 0 0
New York
Country [30] 0 0
United States of America
State/province [30] 0 0
North Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
North Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Ohio
Country [33] 0 0
United States of America
State/province [33] 0 0
Oklahoma
Country [34] 0 0
United States of America
State/province [34] 0 0
Oregon
Country [35] 0 0
United States of America
State/province [35] 0 0
Pennsylvania
Country [36] 0 0
United States of America
State/province [36] 0 0
Rhode Island
Country [37] 0 0
United States of America
State/province [37] 0 0
South Carolina
Country [38] 0 0
United States of America
State/province [38] 0 0
South Dakota
Country [39] 0 0
United States of America
State/province [39] 0 0
Tennessee
Country [40] 0 0
United States of America
State/province [40] 0 0
Texas
Country [41] 0 0
United States of America
State/province [41] 0 0
Vermont
Country [42] 0 0
United States of America
State/province [42] 0 0
Virginia
Country [43] 0 0
United States of America
State/province [43] 0 0
Washington
Country [44] 0 0
United States of America
State/province [44] 0 0
West Virginia
Country [45] 0 0
United States of America
State/province [45] 0 0
Wisconsin
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
British Columbia
Country [48] 0 0
Canada
State/province [48] 0 0
Manitoba
Country [49] 0 0
Canada
State/province [49] 0 0
Nova Scotia
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
Canada
State/province [51] 0 0
Quebec
Country [52] 0 0
Canada
State/province [52] 0 0
Saskatchewan
Country [53] 0 0
Israel
State/province [53] 0 0
Petah Tikua
Country [54] 0 0
Israel
State/province [54] 0 0
Tel Hashomer
Country [55] 0 0
Puerto Rico
State/province [55] 0 0
San Juan

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kara Kelly, MD
Address 0 0
Children's Oncology Group
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 information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01026220