Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01065129 · ClinicalTrials.gov registry record · Phase 1

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) in Combination With Azacitidine for the Treatment of Myelodysplastic Syndrome (MDS)

A Phase 1 study of Myelodysplastic Syndromes, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target
1
Study location

NCT01065129: Completed Phase 1 study of Myelodysplastic Syndromes, sponsored by Washington University School of Medicine.

NCT01065129 is a Phase 1 study of Myelodysplastic Syndromes that has completed, run by Washington University School of Medicine. The registered enrollment target is 28 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes 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.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01065129, a Phase 1 study of Myelodysplastic Syndromes, has completed, sponsored by Washington University School of Medicine.

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

Study Summary

Our main objectives are to determine the optimal dose and schedule of plerixafor + G-CSF and azacitidine in patients with MDS and determine the safety and tolerability of plerixafor + G-CSF and azacitidine.

Primary Outcome

The observation period for bone marrow aplasia as a DLT will be 42 days after the start of the second cycle of treatment or until the documentation of progression to leukemia. For all other toxicities, the DLT observation period will be 28 days from the start of treatment.

Conditions Studied

Interventions

  • DRUG Azacitidine
  • DRUG G-CSF
  • DRUG Plerixafor

Study Locations (1)

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2010-09-02
Est. Completion 2016-10-18
Phase Phase 1

What the finished NCT01065129 record still lists

NCT01065129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 3 interventions - of which Azacitidine is the first listed.

NCT01065129 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT01065129 about?

NCT01065129 is a clinical study titled "Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) in Combination With Azacitidine for the Treatment of Myelodysplastic Syndrome (MDS)". Our main objectives are to determine the optimal dose and schedule of plerixafor + G-CSF and azacitidine in patients with MDS and determine the safety and tolerability of plerixafor + G-CSF and azacitidine.

What is the current status of trial NCT01065129?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2010-09-02. Estimated completion is 2016-10-18.

What conditions does trial NCT01065129 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes.

What interventions are being tested in trial NCT01065129?

The interventions under investigation include: Azacitidine (DRUG), G-CSF (DRUG), Plerixafor (DRUG).

Who is sponsoring clinical trial NCT01065129?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01065129 being conducted?

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

Similar trials for Myelodysplastic Syndromes

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 NCT01065129's enrollment target sits among peer trials

28 125th of 173 higher than 49 of 173 other Myelodysplastic Syndromes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03471117 · 28 participants · Phase 4

    Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients

  • NCT03523975 · 28 participants · Phase 1

    Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

  • NCT03608631 · 28 participants · Phase 1

    iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation

  • NCT03810651 · 28 participants · Early Phase 1

    Pencil Beam Scanning in Patients With Renal Tumors

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT01065129, the US trial registry maintained by the National Library of Medicine. NCT01065129 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.