Clinical trial · Interventional
PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia in Blast Phase, or Myelodysplastic Syndrome
Phase I Study of PS-341 in Acute Myeloid Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase
NCT00005064CI-TRIAL-00009055completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I trial to study the effectiveness of PS-341 in treating patients who have refractory or relapsed acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia in blast phase, or myelodysplastic syndrome. PS-341 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Promyelocytic Leukemia (M3) | Adult Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Blastic Phase Chronic Myelogenous Leukemia | Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Previously Treated Myelodysplastic Syndromes | Myelodysplastic Syndrome | CURATED_BROADER | 0.78 |
| Recurrent Adult Acute Lymphoblastic Leukemia | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Refractory Anemia With Excess Blasts | Myelodysplastic Syndrome with Excess Blasts | ALIAS | 0.90 |
| Refractory Anemia With Excess Blasts in Transformation | — | UNRESOLVED | — |
| Relapsing Chronic Myelogenous Leukemia | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bortezomib)
- description
- Patients receive PS-341 IV bolus twice weekly for 4 weeks followed by 2 weeks of rest. Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.
- interventionNames
- Drug: bortezomib
Primary outcomes (1)
- measure
- The occurrence of greater or equal grade 3 toxicity
- timeFrame
- 35 days
- description
- Graded using the NCI CTC version 2.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * AML, ALL, or high-risk MDS (R-AEB or RAEB-t) that has: * Not responded (no CR) to initial induction chemotherapy, or * Recurred after an initial CR of \< 1 year, or * Recurred after an initial CR of \> 1 year and failed to respond to an initial re-induction attempt, or * Recurred more than once, OR * Chronic myeloid leukemia in myeloid blast phase * Patients with CML blast phase may receive PS-341 as their first therapy for blast phase or after failing other treatments for blast phase * Patients with refractory or relapsed acute promyelocytic leukemia are eligible provided they have failed an ATRA-containing regimen * Patients who are likely to benefit from allogeneic bone marrow transplantation (i.e., age \< 60 years of physiological age with histocompatible donor) should be excluded from this study unless such therapy is not feasible * ECOG performance status =\< 52 (Karnofsky \>= 50%) * Total bilirubin \< 1.6 mg/ml * ALT or AST =\< 2.5 times the institutional upper limit of normal * Creatinine \< 1.6 mg/ml or creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy; use of hydroxyurea on patients with rapidly proliferative disease (i.e., absolute peripheral blood blast count \>= 5 x 10\^9/L, and increasing by \>= 1 x 10\^9/L/24 hrs) is allowed up to 24 hours prior to the start of therapy with PS-341 * The effects of PS-341 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Because the potential risk of toxicity in nursing infants secondary to PS-341 treatment of the mother is unknown but may be harmful, breastfeeding should be discontinued if the mother is treated with PS-341 * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients undergoing therapy with other investigational agents * Patients with known brain metastases or CNS disease should be excluded from this clinical trail because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other toxicities * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia * HIV-positive patients receiving, anti-retroviral thearpy (HAART) are excluded from the study because of possible pharmacokinetic interactions; appropriate studies will be undertaken in patients receiving, HAART therapy when indicated
References
Publications (0)
Data not yet available
No reference posted for this study.