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NCT01681537 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide Plus Chemotherapy for AML
A Phase 1 study of Acute Myelogenous Leukemia, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 3
- Study locations
NCT01681537: Completed Phase 1 study of Acute Myelogenous Leukemia, sponsored by Massachusetts General Hospital.
NCT01681537 is a Phase 1 study of Acute Myelogenous Leukemia that has completed, run by Massachusetts General Hospital. The registered enrollment target is 36 participants, below the 139-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (74% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01681537, a Phase 1 study of Acute Myelogenous Leukemia, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 3
- Study locations
Study Summary
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination of drugs to use for further studies. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved this combination of drugs for AML. As part of this research study, you will take lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered investigational in this research study because it is not approved by the FDA for patients with AML. Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or IMID. This drug is successful in the treatment of patients with multiple myeloma and some patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that lenalidomide may also be effective in patients with AML. Since we know that many patients who receive MEC chemotherapy alone do not have a prolonged remission (time free from leukemia), we are studying the addition of lenalidomide to MEC. In this research study, we are looking for the highest dose of lenalidomide that can be given safely with MEC.
Primary Outcome
Evaluation of the safety of lenalidomide in combination with conventional chemotherapy for relapsed acute myelogenous leukemia. Dose limiting toxicity is defined as a Grade IV rash or delayed neutrophil or platelet recovery beyond Day 45 after start of chemotherapy in the absence of disease
Conditions Studied
Interventions
- DRUG Etoposide
- DRUG Lenalidomide
- DRUG Cytarabine
- DRUG Mitoxantrone
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01681537 record still lists
NCT01681537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 139-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Acute Myelogenous Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Etoposide is the first listed.
NCT01681537 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01681537 about?
NCT01681537 is a clinical study titled "Lenalidomide Plus Chemotherapy for AML". This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination of drugs to use for further studies. "Investigational" means that the combin...
What is the current status of trial NCT01681537?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-09. Estimated completion is 2015-12.
What conditions does trial NCT01681537 study?
This clinical trial studies the following conditions: Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT01681537?
The interventions under investigation include: Etoposide (DRUG), Lenalidomide (DRUG), Cytarabine (DRUG), Mitoxantrone (DRUG).
Who is sponsoring clinical trial NCT01681537?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01681537 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01681537's enrollment target sits among peer trials
36 21st of 38 higher than 14 of 38 other Acute Myelogenous Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myelogenous 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.
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