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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00070447




Registration number
NCT00070447
Ethics application status
Date submitted
3/10/2003
Date registered
7/10/2003
Date last updated
28/01/2014

Titles & IDs
Public title
Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Scientific title
Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma
Secondary ID [1] 0 0
ECOG-E1499
Secondary ID [2] 0 0
CDR0000334470
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
Other interventions - rituximab
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - prednisone
Treatment: Drugs - vincristine sulfate
Treatment: Other - yttrium Y 90 ibritumomab tiuxetan

Other interventions: rituximab


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: doxorubicin hydrochloride


Treatment: Drugs: prednisone


Treatment: Drugs: vincristine sulfate


Treatment: Other: yttrium Y 90 ibritumomab tiuxetan


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

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed mantle cell lymphoma with expression of bcl-1 and CD20

- Stage II-IV disease

- Measurable or evaluable disease

- Measurable disease defined as at least 1 bidimensionally measurable lesion at
least 2 cm by imaging scan

- A spleen at least 17 cm or having discrete filling defects by CT scan will
constitute evaluable disease provided that no explanation other than lymphomatous
involvement (e.g., portal hypertension or other liver disease) is likely

- No known CNS lymphoma

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 6 months

Hematopoietic

- WBC greater than 2,500/mm^3*

- Platelet count greater than 100,000/mm^3* NOTE: *Unless due to disease in bone marrow

Hepatic

- Bilirubin less than 1.5 mg/dL (1.5-3.0 mg/dL if due to liver involvement by lymphoma)

- ALT and AST no greater than 2.5 times upper limit of normal (unless due to liver
involvement by lymphoma)

Renal

- Creatinine less than 2.0 mg/dL

- Calcium no greater than 11.5 mg/dL

Cardiovascular

- LVEF greater than 45%

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 year after study
participation

- HIV negative

- No other malignancy except treated carcinoma in situ of the cervix or squamous cell or
basal cell skin cancer or any other surgically cured malignancy from which the patient
has been disease-free for at least 3 years

- No other concurrent serious medical condition or active infection that would preclude
ability to deliver standard prednisone, cyclophosphamide, doxorubicin, and vincristine
(CHOP) chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Prior corticosteroids allowed provided the course was no more than 2 weeks in duration

Radiotherapy

- No prior radiotherapy

Surgery

- Not specified
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
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
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
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)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
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Alabama
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California
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Dakota
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Ohio
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Oklahoma
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Pennsylvania
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South Dakota
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Tennessee
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Texas
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Wisconsin
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Peru
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Lima
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Puerto Rico
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San Juan
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South Africa
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Pretoria

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan,
can locate cancer cells and either kill them or deliver radioactive cancer-killing substances
to them without harming normal cells. Drugs used in chemotherapy, such as prednisone,
cyclophosphamide, doxorubicin, and vincristine, use different ways to stop cancer cells from
dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy
may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab and combination
chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with
previously untreated mantle cell lymphoma.
Trial website
https://clinicaltrials.gov/show/NCT00070447
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mitchell R. Smith, MD, PhD
Address 0 0
Fox Chase 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

Summary results
Other publications