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NCT01132573 · ClinicalTrials.gov registry record · Phase 1

Entinostat and Clofarabine in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Poor-Risk Acute Lymphoblastic Leukemia or Bilineage/Biphenotypic Leukemia

A Phase 1 study of Recurrent Adult Acute Lymphoblastic Leukemia and Untreated Adult Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
27
Enrollment target
4
Study locations

NCT01132573: Completed Phase 1 study of Recurrent Adult Acute Lymphoblastic Leukemia and Untreated Adult Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).

NCT01132573 is a Phase 1 study of Recurrent Adult Acute Lymphoblastic Leukemia and Untreated Adult Acute Lymphoblastic Leukemia that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 67-participant average among 8 other Recurrent Adult Acute Lymphoblastic Leukemia trials with a reported enrollment target (60% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01132573, a Phase 1 study of Recurrent Adult Acute Lymphoblastic Leukemia and Untreated Adult Acute Lymphoblastic Leukemia, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target
4
Study locations

Study Summary

This phase I trial studies the side effects and best dose of entinostat when given together with clofarabine in treating patients with newly diagnosed, relapsed, or refractory poor-risk acute lymphoblastic leukemia or bilineage/biphenotypic leukemia. Entinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving entinostat with clofarabine may kill more cancer cells.

Primary Outcome

The frequency of the observed toxicities will be tabulated by type and grade.

Interventions

  • OTHER laboratory biomarker analysis
  • OTHER pharmacological study
  • DRUG clofarabine
  • DRUG entinostat

Study Locations (4)

Colorado

  • University of Colorado Anschutz Medical Campus - Aurora
  • University of Colorado - Denver

Maryland

  • University of Maryland/Greenebaum Cancer Center - Baltimore
  • Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center - Baltimore

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2010-04
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01132573 record still lists

NCT01132573 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 67-participant average among 8 other Recurrent Adult Acute Lymphoblastic Leukemia trials with a reported enrollment target (60% lower).

The record links to 4 conditions, with Recurrent Adult Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT01132573 reports a single indexed study location in Colorado, Maryland.

Frequently Asked Questions

What is clinical trial NCT01132573 about?

NCT01132573 is a clinical study titled "Entinostat and Clofarabine in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Poor-Risk Acute Lymphoblastic Leukemia or Bilineage/Biphenotypic Leukemia". This phase I trial studies the side effects and best dose of entinostat when given together with clofarabine in treating patients with newly diagnosed, relapsed, or refractory poor-risk acute lymphoblastic leukemia or bilineage/biphenotypic leukemia. Entinostat may stop the growth of cancer cells by...

What is the current status of trial NCT01132573?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2010-04.

What conditions does trial NCT01132573 study?

This clinical trial studies the following conditions: Recurrent Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Lymphoblastic Leukemia, Acute Leukemias of Ambiguous Lineage, Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia.

What interventions are being tested in trial NCT01132573?

The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), clofarabine (DRUG), entinostat (DRUG).

Who is sponsoring clinical trial NCT01132573?

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

Where is trial NCT01132573 being conducted?

This trial has 4 study locations across Colorado, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Recurrent Adult Acute Lymphoblastic Leukemia

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 NCT01132573's enrollment target sits among peer trials

27 8th of 8 higher than 1 of 8 other Recurrent Adult Acute Lymphoblastic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Adult Acute Lymphoblastic Leukemia 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 NCT01132573, the US trial registry maintained by the National Library of Medicine. NCT01132573 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.