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Anti-metabolites

Intensity Modulated Total Marrow Irradiation + Fludarabine Phosphate + Melphalan for Hematologic Cancers

Phase 1
Recruiting
Led By Hongtao Liu
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance status of 70 or above
No evidence of chronic active hepatitis or cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is testing IMTMI to see if it's less toxic and more effective than other types of radiation therapy when given with fludarabine and melphalan to patients with relapsed blood cancer before a stem cell transplant.

Who is the study for?
This trial is for patients with relapsed blood cancers like AML or high-risk MDS, who are undergoing a second stem cell transplant. They should have good kidney and liver function, not be pregnant, HIV-negative, and have a Karnofsky performance status of 70+. The donor can be the same as the first transplant or a different matched donor.Check my eligibility
What is being tested?
The trial tests intensity modulated total marrow irradiation (IMTMI) combined with fludarabine phosphate and melphalan before a second stem cell transplant. It aims to see how well this approach works in stopping cancer growth and preventing immune rejection of the new stem cells.See study design
What are the potential side effects?
Potential side effects include damage to normal bone marrow cells leading to low blood counts, increased risk of infections due to immune system suppression, organ inflammation from radiation therapy, nausea from chemotherapy drugs, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself but cannot carry on normal activity or do active work.
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I do not have chronic hepatitis or cirrhosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
MTD of conditioning regimen defined as any grade III or higher dose-limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Secondary outcome measures
Overall incidence of adverse events, graded according to the NCI CTCAE version 4.0
Time to neutrophil engraftment
Time to platelet engraftment
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (IMTMI, combination chemotherapy, PBSCT or BMT)Experimental Treatment10 Interventions
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes daily on days -7 to -3 and melphalan IV on day -2. Patients also undergo IMTMI BID for 2 to 5 days between days -7 to -3. TRANSPLANT: Patients undergo allogeneic PBSCT or BMT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO BID on days -2 to 180 with taper thereafter and mycophenolate mofetil IV every 8 hours or PO on days 0-28 (for matched donors) or days 0-40 (for alternative donors) with taper to day 60.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Bone Marrow Transplantation
2009
Completed Phase 2
~530
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Total Marrow Irradiation
2014
Completed Phase 1
~20
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Tacrolimus
2011
Completed Phase 4
~4740
Melphalan
2008
Completed Phase 3
~1500
Mycophenolate Mofetil
1997
Completed Phase 4
~2380

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,018 Previous Clinical Trials
734,585 Total Patients Enrolled
4 Trials studying Myelodysplastic Syndromes (MDS)
140 Patients Enrolled for Myelodysplastic Syndromes (MDS)
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,371 Total Patients Enrolled
116 Trials studying Myelodysplastic Syndromes (MDS)
31,792 Patients Enrolled for Myelodysplastic Syndromes (MDS)
Hongtao LiuPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center
5 Previous Clinical Trials
203 Total Patients Enrolled
1 Trials studying Myelodysplastic Syndromes (MDS)
12 Patients Enrolled for Myelodysplastic Syndromes (MDS)

Media Library

Fludarabine Phosphate (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02333162 — Phase 1
Myelodysplastic Syndromes (MDS) Research Study Groups: Treatment (IMTMI, combination chemotherapy, PBSCT or BMT)
Myelodysplastic Syndromes (MDS) Clinical Trial 2023: Fludarabine Phosphate Highlights & Side Effects. Trial Name: NCT02333162 — Phase 1
Fludarabine Phosphate (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02333162 — Phase 1
~9 spots leftby Dec 2028
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