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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
Patients must have adequate Karnofsky performance status (KPS) and hematopoietic cell transplantation-comorbidity index (HCT-CI) scores: Patients < age 60 years must have a KPS of >= 80% and an HCT-CI score of 5 or less, Patients aged 60 to 65 years must have a KPS of >= 80% and an HCT-CI score of 4 or less, Patients aged 66 to 69 years must have a KPS of 90% and an HCT-CI score of 3 or less, Patients aged 70 years or more must have a KPS of 90% and an HCT-CI score of 2 or less, Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator and at least 1 co-investigator not on the primary care team of the patient. This is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than guideline HCT-CI points. An example is a patient with a solid tumor malignancy in their remote history (adds 3 points to HCT-CI total) where the treatment for the malignancy occurred years to decades before and there has been complete recovery of toxicities, Patients must be willing to use contraception if they have childbearing potential, Patient or patient's guardian is able to give informed consent, Patients should have a life expectancy of >= 6 months for reasons other than their underlying hematologic/oncologic disorder
Adequate liver function as defined by a serum bilirubin =< 1.8, aspartate aminotransferase or alanine aminotransferase =< 2.5 x upper limit of normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I have a donor who is an exact match for my bone marrow transplant.
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I have a blood-related cancer or condition and a partially matched donor.
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I have a blood cancer or disorder and a partially matched donor for a transplant.

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
Incidence of treatment-related mortality (TRM)
Secondary outcome measures
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
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Tacrolimus
2011
Completed Phase 4
~4740
Cyclophosphamide
1995
Completed Phase 3
~3780
Total-Body Irradiation
1997
Completed Phase 3
~1180
Donor Lymphocyte Infusion
1995
Completed Phase 2
~50
Fludarabine
2012
Completed Phase 3
~1100
Melphalan
2008
Completed Phase 3
~1500

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
443 Previous Clinical Trials
145,433 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

Frequently Asked Questions

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

Has Hematopoietic Cell Transplantation been researched in other studies?

"Currently, 1056 Hematopoietic Cell Transplantation trials are in progress with 192 reaching the Phase 3 stage. Of those studies, many are based near Philadelphia, PA but there are over 30k clinical trial sites offering these treatments worldwide."

Answered by AI

Has Hematopoietic Cell Transplantation been validated by the FDA?

"There is some evidence of the safety profile for Hematopoietic Cell Transplantation, so it has been given a score of 2."

Answered by AI

Is there a window of opportunity to join this scientific experiment?

"The clinical trial hosted on clinicaltrials.gov is actively seeking candidates, with its initial posting being the 25th of October 2021 and its most recent edit taking place on April 1st 2022."

Answered by AI

What conditions usually benefit from Hematopoietic Cell Transplantation?

"Hematopoietic Cell Transplantation has been authorised to treat a variety of medical conditions, such as dermatitis and atopic diseases, multiple sclerosis, acute myelocytic leukemia."

Answered by AI

What is the participant count for this clinical research endeavor?

"Affirmative. According to information provided on clinicaltrials.gov, this trial is actively looking for participants and was initially posted on October 25th 2021. It was last updated April 1st 2022 and requires 67 volunteers from a single medical centre."

Answered by AI
~11 spots leftby Oct 2024