Phase 2 N=78 Treatment

S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00551460 ↗

Enrolled (actual)

Serious AEs

15.7%

Results posted

Dec 2017

Primary outcome: Primary: Continuous Complete Remission at 3 Years — 74 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: arsenic trioxide (Drug); gemtuzumab ozogamicin (Drug); mercaptopurine (Drug); methotrexate (Drug); tretinoin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SWOG Cancer Research Network
Primary completion: Jun 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.