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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical improvement

Severe acute GVHD

donor chimerism

+1 more

Secondary study objectives

Absolute neutrophil count

Disease relapse

Non-relapse mortality

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met