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NCT00357032 · ClinicalTrials.gov registry record · Phase 2

PXD101 in Treating Patients With Acute Myeloid Leukemia

A Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
12
Enrollment target
1
Study location

NCT00357032: Completed Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by National Cancer Institute (NCI).

NCT00357032 is a Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00357032, a Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory acute myeloid leukemia or older patients with newly diagnosed acute myeloid leukemia. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Primary Outcome

Clinical responses were measured according to International Working Group criteria. Bone marrow studies were repeated at a minimum of every three cycles. Per International Working Group criteria: Complete Response (CR): Repeat bone marrow show \<5% myeloblasts, and peripheral blood evaluations lasting \>=2 months of hemoglobin(\>110 g/L), neutrophils(\>=1.5x10\^9/L), platelets(\>=100x10\^9/L), blasts (0%) and no dysplasia

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG belinostat

Study Locations (1)

California

  • City of Hope - Duarte

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2006-05
Est. Completion 2010-07
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00357032 record still lists

NCT00357032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (90% lower).

The record links to 8 conditions, with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities appearing as the primary indexed condition, and to 2 interventions - of which laboratory biomarker analysis is the first listed.

NCT00357032 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT00357032 about?

NCT00357032 is a clinical study titled "PXD101 in Treating Patients With Acute Myeloid Leukemia". This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory acute myeloid leukemia or older patients with newly diagnosed acute myeloid leukemia. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocki...

What is the current status of trial NCT00357032?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2006-05. Estimated completion is 2010-07.

What conditions does trial NCT00357032 study?

This clinical trial studies the following conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22).

What interventions are being tested in trial NCT00357032?

The interventions under investigation include: laboratory biomarker analysis (OTHER), belinostat (DRUG).

Who is sponsoring clinical trial NCT00357032?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00357032 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00357032's enrollment target sits among peer trials

12 27th of 29 higher than 3 of 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00357032, the US trial registry maintained by the National Library of Medicine. NCT00357032 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.