A Phase 2 interventional study of bortezomib in Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Minimally Differentiated Myeloid Leukemia (M0) and Adult Acute Myeloblastic Leukemia Without Maturation (M1), sponsored by Fred Hutchinson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
This phase II trial studies how well bortezomib works in treating patients with high-risk acute myeloid leukemia (AML) in remission. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES:
I. To determine if bortezomib when given as maintenance therapy for six months post-remission can improve the progression-free survival (PFS) rate by 50% (or 4.5 months) in first remission patients with high-risk AML.
SECONDARY OBJECTIVES:
I. To determine the overall survival (OS) after maintenance therapy with bortezomib in first remission AML patients.
II. To assess the safety and tolerability of subcutaneous (SC) administration of bortezomib given as maintenance therapy to first remission AML patients.
OUTLINE:
Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 2 years, and then annually for 3 years.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 6 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Favorable AML features defined as the following:
Uncontrolled or significant cardiovascular disease, including:
Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: bortezomib
Given SC
Also known as: LDP 341, MLN341, VELCADE
Progression Free Survival (PFS)
Number of days from enrollment to recurrence of acute myeloid leukemia as determined by the reappearance of blasts in the blood or marrow
Time frame: Up to 2 years
| Milestone | Treated Patients |
|---|---|
| Started | 6 |
| Completed | 2 |
| Not completed | 4 |
| Withdrew: Lack of efficacy | 3 |
| Withdrew: Adverse event | 1 |
Number of days from enrollment to recurrence of acute myeloid leukemia as determined by the reappearance of blasts in the blood or marrow
| days | Treated Patients |
|---|---|
| Progression Free Survival (PFS) | 107 (14 to 575) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Enzyme Inhibitor Therapy) | 5/6 (83.3%) | 2/6 (33.3%) | 1/6 (16.7%) |
| Event | Treatment (Enzyme Inhibitor Therapy) |
|---|---|
| Altered Mental StatusNervous system disorders | 1/6 |
| CholechystitisGastrointestinal disorders | 1/6 |
| Event | Treatment (Enzyme Inhibitor Therapy) |
|---|---|
| Peripheral neuropathyNervous system disorders | 1/6 |
| Age, Continuous(years) | Treatment (Enzyme Inhibitor Therapy) |
|---|---|
| Median | 78 (61 to 87) |
| Sex: Female, Male(Participants) | Treatment (Enzyme Inhibitor Therapy) |
|---|---|
| Female | 3 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Enzyme Inhibitor Therapy) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (Enzyme Inhibitor Therapy) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Enzyme Inhibitor Therapy) |
|---|---|
| United States | 6 |
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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