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IMRT-TMI With Fludarabine as Myeloablative Conditioning for Allogeneic HSCT

NCT03696537 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-03-09

No results posted yet for this study

Summary

This is a phase I/II clinical trial on the use of total marrow irradiation (TMI) given concurrently with fludarabine, a chemotherapy drug commonly used to treat leukemia, as a myeloablative therapy for patients undergoing Allo-HSCT. TMI is a targeted technique to deliver radiation to the bone marrow while minimizing dose to other normal organs in the body. In phase I of the clinical study, the dose of radiation to the bone marrow will be incrementally increased to determine the highest tolerated TMI dose. In phase II, the effectiveness of the TMI-fludarabine conditioning regimen utilizing that dose of radiation will be studied. Acute and long-term toxicity data as well as quality of life data will also be studied.

\*Stopping criteria was met during the first dose level cohort in Phase l. The trial will not continue into Phase II as originally planned.

Conditions

Interventions

DRUG

Fludarabine

Fludarabine 30 mg/m2/day IV (total 5 doses) administered days -7 through -3 of conditioning regimen

RADIATION

Total Marrow Irradiation (TMI)

TMI will be delivered twice a day, at least 6 hours apart, on days -7 through -3 (total of 10 fractions) of conditioning regimen

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • Naoyuki G. Saito, M.D., Ph.D.

    lead OTHER

Principal Investigators

  • Naoyuki G Saito, MD PhD · Indiana University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2020-07-08
Completion
2021-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03696537 on ClinicalTrials.gov