Phase 3 N=637 Randomized Treatment

S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML

Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00085709 ↗

Enrolled (actual)

637

Serious AEs

8.5%

Results posted

Aug 2012

Primary outcome: Primary: 2-year Disease-free Survival (DFS) — 39; 50 Percentage of population — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: gemtuzumab ozogamicin (Drug); observation (Other); Cytosine arabinoside (Drug); Daunomycin (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: SWOG Cancer Research Network
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY 2-year Disease-free Survival (DFS)	39; 50	<0.001 sig
PRIMARY Complete Remission	203; 207	<0.0025 sig
SECONDARY Toxicity	29; 11; 22; 2; 32; 11	—

Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia. PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspiration and biopsy* within the past 14 days
No M3 disease NOTE: *Patients with marked leukocytosis may be registered before the availability of biopsy results if the absolute blast count is ≥ 100,000 cells/µL
No blastic transformation of chronic myelogenous leukemia
No pre-existing hematologic disorder evolving to AML (e.g., myelodysplasia or secondary leukemia)

PATIENT CHARACTERISTICS:

Age

18 to 60

Performance status

Zubrod 0-3

Life expectancy

Not specified

Hematopoietic

See Disease Characteristics

Hepatic

Bilirubin ≤ 2 times upper limit of normal (ULN)
AST and ALT ≤ 3 times ULN
No known hepatitis B or C infection
No known liver disease

Renal

Not specified

Cardiovascular

LVEF ≥ 50% by MUGA or echocardiogram
No unstable cardiac arrhythmias
No unstable angina

Other

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 II cancer currently in complete remission
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior systemic chemotherapy
Prior hydroxyurea to control high cell counts allowed
No more than 1 prior dose of intrathecal chemotherapy for acute leukemia
Concurrent intrathecal chemotherapy allowed during induction therapy

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00085709). 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.