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

NCT01398501 · ClinicalTrials.gov registry record · Phase 1

Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant

A Phase 1 study of Acute Myeloid Leukemia, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target
2
Study locations

NCT01398501: Completed Phase 1 study of Acute Myeloid Leukemia, sponsored by Massachusetts General Hospital.

NCT01398501 is a Phase 1 study of Acute Myeloid Leukemia that has completed, run by Massachusetts General Hospital. The registered enrollment target is 22 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01398501, a Phase 1 study of Acute Myeloid Leukemia, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target
2
Study locations

Study Summary

Sorfenib works by slowing the spread of cancer cells. It has been used in other studies for patients with AML with the FLT3-ITD mutation and information from these studies suggests that sorafenib may help to control leukemia. The purpose of this study is to find the highest dose of sorafenib for maintenance therapy that can be safely used in participants with AML who have undergone allogeneic stem cell transplant.

Primary Outcome

To define the maximum tolerated dose (MTD) of maintenance sorafenib after allogeneic HSCT

Conditions Studied

Interventions

  • DRUG Sorafenib

Study Locations (2)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana-Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2011-08
Est. Completion 2016-08
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

What the finished NCT01398501 record still lists

NCT01398501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (81% lower).

The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Sorafenib is the first listed.

NCT01398501 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01398501 about?

NCT01398501 is a clinical study titled "Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant". Sorfenib works by slowing the spread of cancer cells. It has been used in other studies for patients with AML with the FLT3-ITD mutation and information from these studies suggests that sorafenib may help to control leukemia. The purpose of this study is to find the highest dose of sorafenib for mai...

What is the current status of trial NCT01398501?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-08. Estimated completion is 2016-08.

What conditions does trial NCT01398501 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia.

What interventions are being tested in trial NCT01398501?

The interventions under investigation include: Sorafenib (DRUG).

Who is sponsoring clinical trial NCT01398501?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01398501 being conducted?

This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Acute Myeloid 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 NCT01398501's enrollment target sits among peer trials

22 236th of 306 higher than 64 of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid 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

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

  • NCT03099356 · 22 participants · Phase 2

    Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer

  • NCT03676647 · 22 participants

    Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules

  • NCT04569591 · 22 participants · NA

    DDAVP for Pituitary Adenoma

  • NCT04640987 · 22 participants · Phase 1

    Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01398501, the US trial registry maintained by the National Library of Medicine. NCT01398501 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.