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NCT02122081 · ClinicalTrials.gov registry record · Phase 1
Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies
A Phase 1 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by Sumithira Vasu.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT02122081: Completed Phase 1 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by Sumithira Vasu.
NCT02122081 is a Phase 1 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) that has completed, run by Sumithira Vasu. The registered enrollment target is 33 participants, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02122081, a Phase 1 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), has completed, sponsored by Sumithira Vasu.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot clinical trial aims to assess feasibility and tolerability of using an LINAC based "organ-sparing marrow-targeted irradiation" to condition patients with high-risk hematological malignancies who are otherwise ineligible to undergo myeloablative Total body irradiation (TBI)-based conditioning prior to allogeneic stem cell transplant. The target patient populations are those with ALL, AML, MDS who are either elderly (\>50 years of age) but healthy, or younger patients with worse medical comorbidities (HCT-Specific Comorbidity Index Score (HCT-CI) \> 4). The goal is to have the patients benefit from potentially more efficacious myeloablative radiation based conditioning approach without the side effects associated with TBI.
Primary Outcome
Proportions will be derived for incidence of TRM divided by all evaluable patients along with corresponding 95% binomial confidence intervals.
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG tacrolimus
- RADIATION radiation therapy
- DRUG methotrexate
- BIOLOGICAL anti-thymocyte globulin
Study Locations (1)
Ohio
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2015-07-27 |
| Est. Completion | 2022-09-06 |
| Phase | Phase 1 |
What the finished NCT02122081 record still lists
NCT02122081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (72% lower).
The record links to 10 conditions, with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT02122081 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02122081 about?
NCT02122081 is a clinical study titled "Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies". This pilot clinical trial aims to assess feasibility and tolerability of using an LINAC based "organ-sparing marrow-targeted irradiation" to condition patients with high-risk hematological malignancies who are otherwise ineligible to undergo myeloablative Total body irradiation (TBI)-based condition...
What is the current status of trial NCT02122081?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2015-07-27. Estimated completion is 2022-09-06.
What conditions does trial NCT02122081 study?
This clinical trial studies the following conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22).
What interventions are being tested in trial NCT02122081?
The interventions under investigation include: cyclophosphamide (DRUG), tacrolimus (DRUG), radiation therapy (RADIATION), methotrexate (DRUG), anti-thymocyte globulin (BIOLOGICAL).
Who is sponsoring clinical trial NCT02122081?
This trial is sponsored by Sumithira Vasu, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02122081 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
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 NCT02122081's enrollment target sits among peer trials
33 20th of 29 higher than 10 of 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities 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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