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NCT01869114 · ClinicalTrials.gov registry record · Phase 2

Sirolimus and Azacitidine in Treating Patients With High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia That is Recurrent or Not Eligible for Intensive Chemotherapy

A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

Completed
Registry status
Phase 2
Development phase
57
Enrollment target

NCT01869114: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

NCT01869114 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01869114, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

COMPLETED
Registry status
Phase 2
Development phase
57 participants
Enrollment target

Study Summary

This phase II trial studies how well sirolimus and azacitidine works in treating patients with high-risk myelodysplastic syndrome or recurrent acute myeloid leukemia. Sirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sirolimus and azacitidine may kill more cancer cells.

Primary Outcome

MDS: Patients meeting an erythroid response, a platelet response, or a neutrophil response will be considered responders. AML: Patients achieving a complete remission (CR), complete response in the absence of a total platelet recovery (CRp), or partial remission (PR) will be considered responders.

Interventions

  • DRUG Sirolimus
  • DRUG Azacitidine

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2013-07-08
Est. Completion 2024-01-03
Phase Phase 2

What the finished NCT01869114 record still lists

NCT01869114 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 2 interventions - of which Sirolimus is the first listed.

NCT01869114 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01869114 about?

NCT01869114 is a clinical study titled "Sirolimus and Azacitidine in Treating Patients With High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia That is Recurrent or Not Eligible for Intensive Chemotherapy". This phase II trial studies how well sirolimus and azacitidine works in treating patients with high-risk myelodysplastic syndrome or recurrent acute myeloid leukemia. Sirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, suc...

What is the current status of trial NCT01869114?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2013-07-08. Estimated completion is 2024-01-03.

What interventions are being tested in trial NCT01869114?

The interventions under investigation include: Sirolimus (DRUG), Azacitidine (DRUG).

Who is sponsoring clinical trial NCT01869114?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01869114's enrollment target sits among peer trials

57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01869114, the US trial registry maintained by the National Library of Medicine. NCT01869114 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.