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Anti-metabolites

Fludarabine + Total Marrow Irradiation for Blood Cancers

Phase 1 & 2

Waitlist Available

Led By Naoyuki Saito, MD PhD

Research Sponsored by Naoyuki G. Saito, M.D., Ph.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing a new way to give radiation and chemotherapy before a stem cell transplant to people with leukemia or myelodysplasia.

Eligible Conditions

Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose of Total Marrow Irradiation (TMI) followed by 150 mg/m2 fludarabine- Phase I only

Overall survival (OS) rate 1 year post transplant-Phase II only

Secondary outcome measures

Disease free survival

Frequency of non hematologic toxicity

Incidence of acute graft versus host disease

+10 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fludarabine + Total Marrow IrradiationExperimental Treatment1 Intervention

Fludarabine will be administered sequentially after the administration of TMI. TMI will be delivered on Days -11, -10, -9, -8, and -7 (1.4-2.2 gray (GY)/fraction, twice a day) followed by fludarabine on Days -6, -5, -4, -3, and -2 (150 mg/m2, 30 mg/m2/day)

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Who is running the clinical trial?

Naoyuki G. Saito, M.D., Ph.D.Lead Sponsor

1 Previous Clinical Trials

6 Total Patients Enrolled

Naoyuki Saito, MD PhDPrincipal InvestigatorIndiana University

1 Previous Clinical Trials

57 Total Patients Enrolled

Media Library

Fludarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05201183 — Phase 1 & 2

Acute Lymphoblastic Leukemia Research Study Groups: Fludarabine + Total Marrow Irradiation

Acute Lymphoblastic Leukemia Clinical Trial 2023: Fludarabine Highlights & Side Effects. Trial Name: NCT05201183 — Phase 1 & 2

Fludarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05201183 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts still underway for this research project?

"Based on the information available at clinicaltrials.gov, this medical trial is currently open for enrollment with its initial listing published on May 17th 2022 and last amended on June 1st 2022."

Answered by AI

What is the current recruitment size for this clinical research?

"Indeed, the information found on clinicaltrials.gov verifies that this research endeavour is actively recruiting subjects as of June 1st 2022. Initially posted on May 17th 2021, it requires 53 individuals to be enrolled from a single medical institution."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose Escalation Study of Intensity Modulated Total Marrow Irradiation (IMRT-TMI) Followed by Fludarabine as a Myeloablative Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed and Refractory Hematologic Malignancies

Naoyuki G. Saito, M.D., Ph.D. 2023. "A Dose Escalation Study of Intensity Modulated Total Marrow Irradiation (IMRT-TMI) Followed by Fludarabine as a Myeloablative Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed and Refractory Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05201183.