Phase 3
N=105
S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00492856 ↗Enrolled (actual)
105
Serious AEs
5.6%
Results posted
Jul 2014
Primary outcome: Primary: 3-year Disease-free Survival (DFS) Rate — 96; 100 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- mercaptopurine (Drug); methotrexate (Drug); tretinoin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3-year Disease-free Survival (DFS) Rate |
96; 100 | — |
| SECONDARY Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug |
5; 3; 2; 0; 2; 2 | — |
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Sometimes the cancer may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether combination chemotherapy is more effective than observation when given as maintenance therapy in treating acute promyelocytic leukemia.
PURPOSE: This randomized phase III trial is studying tretinoin, mercaptopurine, and methotrexate to see how well they work when given as maintenance therapy compared with observation after combination chemotherapy in treating patients with acute promyelocytic leukemia. (Randomization and observation group closed as of 8/15/10)
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Cytologically confirmed acute promyelocytic leukemia (APL) or the variant form of APL
- Previously untreated disease
- Low- or intermediate-risk disease
- Low-risk disease, defined as white blood cell (WBC) ≤ 10,000/mm^3 and platelet count > 40,000/mm^3
- Intermediate-risk disease, defined as WBC ≤ 10,000/mm^3 and platelet count ≤ 40,000/mm^3
- WBC and platelet count confirming low- or intermediate-risk disease must be obtained within 48 hours prior to study registration unless the patient received tretinoin therapy prior to study registration in which case the WBC and platelet count must be obtained within 48 hours prior to study therapy
- PML-RARα fusion gene positive by reverse transcriptase-polymerase chain reaction (RT-PCR) assay
- No recurrent disease
- Must be registered on clinical trials SWOG-9007 and SWOG-S9910
- Specimens must be collected prior to tretinoin therapy and may be collected after tretinoin therapy
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-3
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for ≥ 1 month prior to, during, and for 2 months after completion of study treatment
- No unstable cardiac arrhythmia or unstable angina
- No other malignancy within the past 5 years except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Adequately treated stage I or II cancer (except for highly aggressive malignancies with a high rate of early relapse) currently in complete remission
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 1 prior dose of intrathecal chemotherapy for acute leukemia
- No prior systemic chemotherapy, hydroxyurea, or leukapheresis for acute leukemia
- Prior tretinoin at a dose of ≤ 45 mg/m^2/day allowed provided it was received ≤ 5 days prior to study registration
Data sourced from ClinicalTrials.gov (NCT00492856). 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.