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Stem Cell Transplant for Lymphoma

Phase 1
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lymphoid malignancies in CR or PR (e.g. non-Hodgkin's lymphoma, prolymphocytic leukemia, CLL)
Myelodysplastic syndromes with <=10% blasts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights

Study Summary

This trial looks at a procedure to help patients with graft failure. The procedure uses CD34 selected grafts to reduce risk of graft versus host disease. It is safe & effective & is being tested for malignant & non-malignant conditions.

Who is the study for?
This trial is for patients with certain blood cancers or tumors who have had a stem cell transplant that didn't work well. They should be in remission or have specific disease features, and not allergic to DMSO. Pregnant women, those without caregivers, non-compliant individuals, or anyone with uncontrolled health issues can't join.Check my eligibility
What is being tested?
The trial tests the infusion of CD34 selected hematopoietic stem cells using CliniMACS Prodigy to reduce graft versus host disease risk after a failed stem cell transplant. It's designed to make the process easier on lab teams and has shown promise in previous studies.See study design
What are the potential side effects?
While specifics aren’t detailed here, similar procedures may include side effects like reactions at the infusion site, infection risks due to immune system impact, mild bone pain from growth factors used before collection of stem cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lymphoid cancer is responding to treatment.
Select...
My condition is a type of blood disorder with less than or equal to 10% immature blood cells.
Select...
My CML is in remission after a more severe phase.
Select...
My AML is in remission but has high-risk features or has come back.
Select...
My ALL is in remission but has high-risk features or has relapsed once or twice.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Clinical improvement
Severe acute GVHD
donor chimerism
+1 more
Secondary outcome measures
Absolute neutrophil count
Disease relapse
Non-relapse mortality
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment populationExperimental Treatment1 Intervention
Patients status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a CD34 selected stem cell boost for graft failure or low graft function will receive a CD34 selected hematopoietic stem cell infusion with or without preceding conditioning. Fludarabine 25 mg/mq day 1 - 5 + 2 Gray Total body irradiation depending on clinician's discretion (with the addition of cyclophosphamide 14.5 mg/kg for two doses for haploidentical or matched unrelated donor with at least one major HLA mismatch). Recommendation to use a conditioning regimen include complete loss of donor chimerism, trilineage cytopenias.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,584 Previous Clinical Trials
2,280,023 Total Patients Enrolled

Frequently Asked Questions

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

Does this research study permit enrollment of individuals over twenty-five years old?

"Eligible participants of this trial must be over 4 weeks old and younger than 75 years of age."

Answered by AI

Can people safely partake in the subject population for this treatment?

"Due to the limited data on efficacy and safety, Treatment population has been assigned a score of 1. This is typical for Phase 1 trials."

Answered by AI

What criteria must individuals meet to be selected for this clinical research?

"This clinical trial is enrolling up to 50 participants with acute myeloid leukemia, aged between 4 weeks and 75."

Answered by AI

What key goals is this trial hoping to accomplish?

"This trial's primary objective is to measure clinical improvement over a 6 year period. Furthermore, secondary outcomes such as relapse rate within one year, overall survival rate after 1 year and absolute neutrophil count (ANC) engraftment will also be assessed."

Answered by AI

Is this research endeavor presently seeking participants?

"As per clinicaltrials.gov, this trial is not presently enrolling patients after first being posted on October 1st 2023 and last updated on September 14th 2023. Despite that, there are over 3300 alternative medical studies actively recruiting at the moment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CD34 Selection Using the Automated CliniMACS Prodigy
Antonio Di Stasi 2024. "CD34 Selection Using the Automated CliniMACS Prodigy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047886.
All > Myelofibrosis
~33 spots leftby Oct 2029
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