Reduced intensity transplant protocol for hematologic malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the safety and efficacy of a reduced intensity conditioning protocol using fludarabine and intermediate-dose total body irradiation (TBI) prior to haplo-identical transplantation. The study focuses on patients with hematologic malignancies who have a matched related donor willing to provide peripheral blood stem cells. The approach aims to assess the outcomes of this transplant method in patients at high risk of relapse following non-myeloablative conditioning. The trial will monitor patient responses and potential complications associated with the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Availability of 3/6 - 5/6 matched related donor with a negative HLA-cross match in the host vs. graft direction willing to donate peripheral blood stem cells
* KPS \>/= 70%
* Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning.

Exclusion Criteria:

* Poor cardiac function (LVEF \<45%)
* Poor pulmonary function (FEV, FVC, DLCO \<60%)
* Poor liver function (bilirubin \>/= 2.5mg/dL; AST or ALT \>3xULN)
* Poor renal function (creatinine clearance \<40mL/min)
* HIV-positive; active HepB or HepC
* Uncontrolled infection
* Pregnant female or not able to practice adequate contraception
* Debilitating medical or psychiatric illness which would preclude their giving informed consent

Where it's running

• Caitlin Guzowski
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Scott Solomon, MD — Bmtga
• Study coordinator: Stacey Brown
• Email: stacey.brown@northside.com
• Phone: 404-480-7965

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.