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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 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.

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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.

Conditions Studied

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) Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia in Remission de Novo Myelodysplastic Syndromes Adult Acute Lymphoblastic Leukemia in Remission Previously Treated Myelodysplastic Syndromes

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

FieldValue
Enrollment Target 33 participants
Start Date 2015-07-27
Est. Completion 2022-09-06
Phase Phase 1

Sponsor

Sumithira Vasu

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02122081

The ClinicalTrials.gov registry entry for NCT02122081 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, 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 listed sponsor is Sumithira Vasu, which has 6 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.