Phase 2
Completed N=78
S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Source: ClinicalTrials.gov NCT00551460 ↗Enrolled (actual)
78
Serious AEs
15.7%
Results posted
Dec 2017
Primary outcomePrimary: Continuous Complete Remission at 3 Years — 74 percentage of participants
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 find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination chemotherapy may be more effective in treating promyelocytic leukemia.
PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination chemotherapy works in treating patients with previously untreated promyelocytic leukemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Complete Remission at 3 Years |
74 | — |
| PRIMARY Mortality Rate at 6 Weeks |
11 | — |
| SECONDARY Frequency of Toxicities |
37; 46; 4; 1; 3; 24 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow examination
- APL-RARα-negative by RT-PCR are not eligible
- High-risk disease, defined as WBC > 100,000/mm^3
- Bone marrow specimens must be made available for cytogenetic studies
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prolonged QTc > 0.47 sec
- No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or stage II cancer from which the patients is currently in complete remission
PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy for acute leukemia
- At least 3 days since prior tretinoin (ATRA) allowed
- Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts allowed
Data sourced from ClinicalTrials.gov (NCT00551460). 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. Informational only — not medical advice.