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Alkylating agents

Bone Marrow Transplant for Blood Cancers

Phase 2
Waitlist Available
Led By Hany Elmariah, MD, MS
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate performance status is defined as Karnofsky score ≥ 70%
Natural killer cell malignancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

Study Summary

This trial is testing a new way to do a bone marrow transplant using cells from a related donor. They will track how well patients do 18 months after the transplant.

Who is the study for?
This trial is for people aged 55+ or with certain health conditions, lacking a fully matched sibling donor, and with specific blood cancers in remission or sensitive to chemotherapy. They must have good organ function, agree to birth control if applicable, and have an HLA-haploidentical relative as a donor.Check my eligibility
What is being tested?
The study tests a transplant of blood cells from half-matched relatives using lower doses of Fludarabine and Melphalan drugs plus whole-body radiation. The goal is to see how many patients are disease-free after 18 months.See study design
What are the potential side effects?
Potential side effects include weakened immune system leading to infections, nausea, mouth sores due to chemotherapy; skin irritation from radiation; and possible organ damage related to the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly able to care for myself and carry out daily activities.
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My condition is related to natural killer cell malignancies.
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I have CML in the accelerated phase and TKIs haven't worked for me or I can't tolerate them.
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My leukemia is in remission.
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I agree to use birth control during the study if I or my partner can become pregnant.
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My blood disorder is severe but with less than 5% cancer cells.
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My blood cancer has less than 5% blast cells, or I've had treatment to reduce it to this level.
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My Burkitt's lymphoma is in its second or later remission.
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My selected donor and I have undergone detailed HLA typing and share a HLA haplotype.
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My AML is in remission with less than 5% of cells being blasts.
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My lymphoma has returned after treatment, is responsive to chemotherapy, but I can't have a stem cell transplant.
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My T-cell lymphoma has returned but responds to chemotherapy and I can't have a stem cell transplant.
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My lymphoma has returned or not responded to treatment, and I've had at least two prior therapies.
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I am 55 or older, or I have significant health issues.
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I do not have a fully matched family donor for a transplant.
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My leukemia/lymphoma is in its second or more remission, or I had a bad reaction to initial treatment.
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My organs are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Free Survival
Secondary outcome measures
Graft vs Host Disease (GVHD) free survival
Overall Survival (OS)
Relapse Free Survival (RFS)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Conditioning Regimen + TransplantExperimental Treatment3 Interventions
All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Melphalan
2008
Completed Phase 3
~1500
Total Body Irradiation
2006
Completed Phase 3
~820

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
541 Previous Clinical Trials
135,412 Total Patients Enrolled
Hany Elmariah, MD, MSPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
65 Total Patients Enrolled
Nelli Bejanyan, MDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Fludarabine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04191187 — Phase 2
Acute Undifferentiated Leukemia Research Study Groups: Conditioning Regimen + Transplant
Acute Undifferentiated Leukemia Clinical Trial 2023: Fludarabine Highlights & Side Effects. Trial Name: NCT04191187 — Phase 2
Fludarabine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04191187 — Phase 2

Frequently Asked Questions

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

What potential adverse side effects have been reported with Total Body Irradiation?

"Due to the nature of a Phase 2 trial, with some safety data present but no efficacy information, Total Body Irradiation was rated as a level 2 for safety."

Answered by AI

How many people have enrolled in this trial?

"Unfortunately, this clinical trial closed its enrollment by August 12th 2022. However, there are 3350 separate studies recruiting patients with Burkitt lymphoma and 442 trials actively admitting participants for Total Body Irradiation treatment."

Answered by AI

Is this research project enrolling participants at present?

"According to the clinicaltrials.gov website, this particular study has no open positions available at present; it was initially published on December 6th 2019 and last updated on August 12th 2022. Nonetheless, there are 3,792 other studies actively recruiting participants across the world today."

Answered by AI

What kinds of conditions does Total Body Irradiation typically help to treat?

"Total Body Irradiation is a common treatment for chronic lymphocytic leukemia, as well as certain stem cell transplantations, amyloidosis cases, and various types of non-Hodgkin's lymphomas."

Answered by AI
~7 spots leftby Apr 2025