Phase 3
N=129
Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00059839 ↗Enrolled (actual)
129
Serious AEs
4.8%
Results posted
Oct 2013
Primary outcome: Primary: Event-free Survival (EFS) — 74; 79 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- doxorubicin hydrochloride (Drug); mercaptopurine (Drug); methotrexate (Drug); prednisone (Drug); vinblastine sulfate (Drug); vincristine sulfate (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival (EFS) |
74; 79 | — |
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. It is not yet known if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed advanced anaplastic large cell lymphoma
- Cluster of differentiation antigen 30 (CD30+)
- Murphy stage III or IV
- No B-cell large cell lymphoma
- No disease limited to the skin (regardless of how wide-spread)
PATIENT CHARACTERISTICS:
Age
- Under 21
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) less than 2.5 times ULN (unless due to lymphoma)
Renal
- Not specified
Cardiovascular
- Shortening fraction (SF) at least 27% by echocardiogram OR
- Ejection fraction (EF) at least 50% by radionuclide angiogram
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Prior steroids for management of a mediastinal mass allowed
Radiotherapy
- Prior limited-dose radiotherapy for a mediastinal mass allowed
Surgery
- Not specified
Data sourced from ClinicalTrials.gov (NCT00059839). 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.