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NCT02029950 · ClinicalTrials.gov registry record · Phase 1
Pomalidomide After Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
A Phase 1 study of Acute Myeloid Leukemia and Myeloproliferative Neoplasm, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 3
- Study locations
NCT02029950: Completed Phase 1 study of Acute Myeloid Leukemia and Myeloproliferative Neoplasm, sponsored by National Cancer Institute (NCI).
NCT02029950 is a Phase 1 study of Acute Myeloid Leukemia and Myeloproliferative Neoplasm that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (57% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02029950, a Phase 1 study of Acute Myeloid Leukemia and Myeloproliferative Neoplasm, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of pomalidomide after combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pomalidomide may kill cancer cells by stopping blood flow to the cancer and by stimulating white blood cells to kill cancer cells. Giving more than one drug (combination chemotherapy) and pomalidomide may kill more cancer cells.
Primary Outcome
The proportion of dose-limiting toxicities at each dose level will be reported with exact binomial 95% confidence intervals. Adverse events will be summarized by dose level for all doses. All toxicities by type and grade will be reported.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Etoposide
- DRUG Cytarabine
- DRUG Daunorubicin Hydrochloride
- DRUG Idarubicin Hydrochloride
Study Locations (3)
Connecticut
- Yale University - New Haven
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-12-16 |
| Est. Completion | 2020-05-13 |
| Phase | Phase 1 |
What the finished NCT02029950 record still lists
NCT02029950 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (57% lower).
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02029950 reports a single indexed study location in Connecticut, Maryland, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02029950 about?
NCT02029950 is a clinical study titled "Pomalidomide After Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". This phase I trial studies the side effects and best dose of pomalidomide after combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, and etoposide, ...
What is the current status of trial NCT02029950?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2013-12-16. Estimated completion is 2020-05-13.
What conditions does trial NCT02029950 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myeloproliferative Neoplasm, High Risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia-2.
What interventions are being tested in trial NCT02029950?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Etoposide (DRUG), Cytarabine (DRUG), Daunorubicin Hydrochloride (DRUG), Idarubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02029950?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02029950 being conducted?
This trial has 3 study locations across Connecticut, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02029950's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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