Phase 3
N=170
Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma
Leukemia · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00002766 ↗Enrolled (actual)
170
Serious AEs
42.4%
Results posted
Feb 2016
Primary outcome: Primary: Complete Remission (CR) — 50; 50; 14; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- dactinomycin (Biological); sargramostim (Biological); carmustine (Drug); cyclophosphamide (Drug); cytarabine (Drug); daunorubicin hydrochloride (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); mercaptopurine (Drug); methotrexate (Drug); mitoxantrone hydrochloride (Drug); pegaspargase (Drug); prednisone (Drug); vincristine sulfate (Drug); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Remission (CR) |
50; 50; 14; 11; 5; 14 | — |
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.
PURPOSE: This randomized phase III trial is studying two different chemotherapy regimens and comparing them to see how well they work in treating adults with acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of one of the following malignancies:
- Acute lymphoblastic leukemia (ALL) of B- or T-cell lineage
- Philadelphia chromosome-positive ALL eligible
- Lymphoblastic lymphoma
- Chronic myelogenous leukemia in lymphoid blast crisis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 20-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- Glucocorticoids for higher bilirubin allowed prior to entry, at principal investigator's discretion
Renal:
- Creatinine no greater than 2.0 mg/dL
- Glucocorticoids or renal radiotherapy for higher creatinine allowed prior to entry, at principal investigator's discretion
Cardiovascular:
- Left ventricular ejection fraction at least 50%
Other:
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- No prior endocrine therapy
Radiotherapy
- No prior radiotherapy
Surgery
- No prior surgery
Data sourced from ClinicalTrials.gov (NCT00002766). 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.