Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03121014 · ClinicalTrials.gov registry record · Phase 2
Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by University of Illinois at Chicago.
- Active
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT03121014: Active Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by University of Illinois at Chicago.
NCT03121014 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is active but no longer recruiting, run by University of Illinois at Chicago. The registered enrollment target is 38 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03121014, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by University of Illinois at Chicago.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is a Phase II clinical trial. Patients will receive intensity modulated total marrow irradiation (TMI) at a dose of 9 Gy with standard myeloablative fludarabine/ i.v. targeted busulfan (FluBu) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT).
Primary Outcome
Using a Simon 2 stage optimal design with α of 0.05 and power of 0.8, 15 patients will be enrolled in the first stage. If greater than 5 patients survive to 1 year without relapse the study will continue into stage 2. Recruitment will then continue to a total of 46 patients. In this expanded cohort, if a total of 18 or more patients survive to 1 year without relapse, the treatment will be judged efficacious and worthy of further study.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG ATG
- RADIATION Total Marrow Irradiation
- PROCEDURE Stem Cell Product Infusion
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-04-24 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What the registry record for NCT03121014 still lists
NCT03121014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT03121014 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03121014 about?
NCT03121014 is a clinical study titled "Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes". The study is a Phase II clinical trial. Patients will receive intensity modulated total marrow irradiation (TMI) at a dose of 9 Gy with standard myeloablative fludarabine/ i.v. targeted busulfan (FluBu) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT).
What is the current status of trial NCT03121014?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2017-04-24. Estimated completion is 2026-04.
What conditions does trial NCT03121014 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes.
What interventions are being tested in trial NCT03121014?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), ATG (DRUG), Total Marrow Irradiation (RADIATION), Stem Cell Product Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT03121014?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03121014 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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 NCT03121014's enrollment target sits among peer trials
38 180th of 306 higher than 126 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
-
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
RECRUITING · Phase 2
-
Venetoclax + Azacitidine vs. Induction Chemotherapy in AML
RECRUITING · Phase 2
-
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
RECRUITING · Phase 2
-
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
RECRUITING · Phase 2
-
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
RECRUITING · Phase 2
-
Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
RECRUITING · Phase 2
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
- NCT01684904 · 38 participants · NA
Proton Therapy for Esophageal Cancer
- NCT03310879 · 38 participants · Phase 2
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6
- NCT03896269 · 38 participants · Phase 1
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
- NCT04085315 · 38 participants · Phase 1
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI