Phase 3
N=393
Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00004228 ↗Enrolled (actual)
393
Serious AEs
13.6%
Results posted
Dec 2013
Primary outcome: Primary: Event-free Survival — 88; 82; 80; 63 percentage of particpants — p=.97
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- asparaginase (Drug); cyclophosphamide (Drug); cytarabine (Drug); daunorubicin hydrochloride (Drug); dexamethasone (Drug); doxorubicin hydrochloride (Drug); leucovorin calcium (Drug); mercaptopurine (Drug); methotrexate (Drug); prednisone (Drug); thioguanine (Drug); vincristine sulfate (Drug); radiation therapy (Radiation)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival |
88; 82; 80; 63; 82; 84 | .97 |
| SECONDARY Percentage of Patients With Overall Survival as Assessed by Time to Death |
96; 84; 88; 81; 85; 85 | — |
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma.
PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed disseminated lymphoblastic lymphoma or localized lymphoblastic lymphoma*
- Less than 25% tumor cells in the bone marrow
- Previously untreated (prior intrathecal cytarabine allowed if protocol therapy begins within 72 hours)
- Stage III or IV disease
- NOTE: *Localized lymphoblastic lymphoma is closed to accrual as of 10/2005
PATIENT CHARACTERISTICS:
Age:
- 1 to 30
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- Adequate cardiac function
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Emergency steroid therapy (if required) must be started within 72 hours prior to protocol therapy
Radiotherapy:
- Emergency radiotherapy (if required) must be started within 72 hours prior to protocol therapy
Surgery:
- Not specified
Other:
- No other prior therapy except for emergency treatment of airway obstruction and/or superior vena cava syndrome
Data sourced from ClinicalTrials.gov (NCT00004228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.