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NCT01375140 · ClinicalTrials.gov registry record · Phase 2

Ruxolitinib and Lenalidomide for Patients With Myelofibrosis

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
31
Enrollment target

NCT01375140: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT01375140 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01375140, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn if the combination of ruxolitinib and lenalidomide can help to control MF. The safety of this study drug combination will also be studied. Ruxolitinib is designed to stop certain proteins (called JAK1 and JAK2) that are found in MF cells from sending signals that may lead to the growth of cancer cells. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.

Primary Outcome

To determine the efficacy of the combination of Ruxolitinib + Lenalidomide in patients with Myelofibrosis (MF). Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT). Objective response rate (ORR), defined as a clinical improvement (CI), partial remission (PR), and complete remission (CR) according to the International Working Group (IWG) Criteria. Complete remission (CR)

Interventions

  • DRUG Lenalidomide
  • DRUG Prednisone
  • DRUG Ruxolitinib

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2011-09-22
Est. Completion 2018-09-05
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01375140 record still lists

NCT01375140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 3 interventions - of which Lenalidomide is the first listed.

NCT01375140 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01375140 about?

NCT01375140 is a clinical study titled "Ruxolitinib and Lenalidomide for Patients With Myelofibrosis". The goal of this clinical research study is to learn if the combination of ruxolitinib and lenalidomide can help to control MF. The safety of this study drug combination will also be studied. Ruxolitinib is designed to stop certain proteins (called JAK1 and JAK2) that are found in MF cells from sen...

What is the current status of trial NCT01375140?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2011-09-22. Estimated completion is 2018-09-05.

What interventions are being tested in trial NCT01375140?

The interventions under investigation include: Lenalidomide (DRUG), Prednisone (DRUG), Ruxolitinib (DRUG).

Who is sponsoring clinical trial NCT01375140?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01375140's enrollment target sits among peer trials

31 1578th of 2000 higher than 419 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 NCT01375140, the US trial registry maintained by the National Library of Medicine. NCT01375140 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.