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Alkylating agents

Reduced-Intensity Conditioning for Blood Cancers

Phase 2
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate liver function as defined by a serum bilirubin =< 1.8, aspartate aminotransferase or alanine aminotransferase =< 2.5 x upper limit of normal
Be older than 18 years old
Must not have
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is looking at whether a less intense conditioning regimen of radiation therapy and chemotherapy prior to a hematopoietic stem cell transplant reduces the rate of treatment-related mortality.

Who is the study for?
This trial is for patients with various blood cancers or disorders who have adequate lung, liver, heart function, and kidney clearance. They must not be HIV positive, pregnant, breastfeeding, or have another active malignancy or central nervous system involvement. Participants need a specific donor match and should meet certain health scores based on age.
What is being tested?
The study tests if a less intense conditioning regimen before hematopoietic stem cell transplant can reduce treatment-related mortality in blood cancer patients. It involves lower doses of radiation and chemotherapy drugs like fludarabine and cyclophosphamide to prepare the body for the transplant.
What are the potential side effects?
Potential side effects may include reactions to medications such as mycophenolate mofetil and tacrolimus (e.g., immune suppression), effects from total-body irradiation (e.g., fatigue, skin changes), plus typical chemotherapy side effects like nausea, hair loss, increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is functioning well, based on recent blood tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any other cancer besides skin cancer that needs only local treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-related mortality (TRM)
Secondary study objectives
Development of relapsed disease
Engraftment
Immune reconstitution
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Radiation-Based Cohort (fludarabine, TBI, infusion)Experimental Treatment7 Interventions
Patients receive fludarabine IV on days -11, -10, -9, and -8, undergo TBI BID on days -10 and -9, undergo DLI on day -6, and receive cyclophosphamide IV on days -3 and -2. Patients begin tacrolimus and mycophenolate mofetil IV on day -1. Patients then undergo HSCT on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.
Group II: Chemotherapy-Based Cohort (fludarabine, melphalan, TBI)Experimental Treatment8 Interventions
Patients receive fludarabine IV on days -11, -10, -9, and -8 and melphalan IV on days -10 and -9. Patients undergo TBI and DLI once on day -6. Patients receive cyclophosphamide IV on days -3 and -2 and begin tacrolimus and mycophenolate mofetil on day -1. Patients undergo hematopoietic stem cell transplant on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 4
~1860
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Donor Lymphocyte Infusion
1995
Completed Phase 2
~50
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Cyclophosphamide
2010
Completed Phase 4
~2320
Total-Body Irradiation
1997
Completed Phase 3
~1180
Melphalan
2008
Completed Phase 3
~1500
Tacrolimus
2019
Completed Phase 4
~5510

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
456 Previous Clinical Trials
149,329 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05031897 — Phase 2
Myeloid Leukemia Research Study Groups: Radiation-Based Cohort (fludarabine, TBI, infusion), Chemotherapy-Based Cohort (fludarabine, melphalan, TBI)
Myeloid Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05031897 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05031897 — Phase 2
~0 spots leftby Oct 2024
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