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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/NCT00002941




Registration number
NCT00002941
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
1/08/2014

Titles & IDs
Public title
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkin's or Non-Hodgkin's Lymphoma
Scientific title
A Pilot Study of Peripheral Blood Stem Cell Transplantation (PBSCT) After Preparative Therapy Consisting of Cyclophosphamide, BCNU, and Etoposide (CBV) for Recurrent and Primarily Refractory Hodgkin's and Non-Hodgkin's Lymphoma
Secondary ID [1] 0 0
COG-A5962
Secondary ID [2] 0 0
A5962
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - carmustine
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - etoposide
Treatment: Drugs - mesna
Treatment: Surgery - peripheral blood stem cell transplantation

Experimental: Reinduction Therapy - Two courses of reinduction chemotherapy followed by bone marrow biopsy and aspirate prior to peripheral blood stem cell (PBSC) harvest. If marrow involvement is still present at harvest, then 2 additional courses of induction chemotherapy are given. The PBSC transplantation preparative regimen should begin within 2 weeks of completing reinduction therapy course, consisting of the following: Carmustine IV over 3 hours on days -8, -7, and -6, Etoposide continuous IV over days -8, -7, and -6, Cyclophosphamide IV over 1 hour daily on days -5, -4, -3, and -2, Mesna as a 15 min infusion before each dose of cyclophosphamide then at 3, 6, 9, and 12 hours after initiation of each cyclophosphamide dose Methylprednisolone IV is given to protect lungs from the toxic effects of carmustine.


Treatment: Drugs: carmustine


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: etoposide


Treatment: Drugs: mesna


Treatment: Surgery: peripheral blood stem cell transplantation
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Failure-free survival rate
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Estimating parameters relevant to recovery of normal bone marrow function
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Predictive value of MRD assessment
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed non-Hodgkin's lymphoma in first relapse or refractory after
primary induction therapy

- Histologically confirmed Hodgkin's lymphoma in first relapse after chemotherapy with
more than one nodal region involved at relapse or refractory after primary induction
therapy (i.e., failed to achieve remission at the conclusion of standard induction
chemotherapy)

- No prior radiotherapy only for low stage nodal disease

- No greater than 4 courses of standard chemotherapy for low stage nodal disease

- CSF or bone marrow involvement at time of study entry is allowed

PATIENT CHARACTERISTICS:

Age:

- 1 to 21 (at initial diagnosis)

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- SGOT or SGPT less than 2.5 times normal

- Bilirubin no greater than 1.5 mg/dL

Renal:

- Creatinine less than 1.5 mg/dL

- Glomerular filtration rate greater than 60 mL/min as measured by radionuclide scan or
24 hour urine collection for creatinine clearance

Cardiovascular:

- Shortening fraction of at least 28% by echocardiogram

- Ejection fraction of at least 40% by radionuclide angiogram echocardiogram

Pulmonary:

- Total lung capacity (TLC) at least 50% OR

- Vital capacity (VC) at least 65% of normal

- DLCO at least 55% of normal

- For children who are uncooperative to pulmonary function testing, no dyspnea at rest
or with mild exercise, and a pulse oximetry of at least 95%

Other:

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- Not specified
Minimum age
1 Year
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
1/04/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
69
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
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
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3052 - Parkville
Recruitment postcode(s) [6] 0 0
6001 - Perth
Recruitment outside Australia
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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. Peripheral stem cell transplantation may allow doctors to give
higher doses of chemotherapy and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
peripheral stem cell transplantation in treating children who have recurrent or refractory
Hodgkin's lymphoma or non-Hodgkin's lymphoma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00002941
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard E. Harris, 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
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Address 0 0
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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/NCT00002941