Hematologic MalignancyNCT05417971
Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
An observational study of Hematologic Malignancy, run by Northside Hospital, Inc. at 1 site in United States.
Trial summary
This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Fludarabine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2022to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female patients with any hematologic malignancy that requires an allogeneic transplant from a halpo-identical matched related donor
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Caitlin Guzowski
Atlanta, Georgia, 30342
Caitlin Guzowski, MBA, MHA, 404-851-8523, caitlin.guzowski@northside.com
H. Kent Holland, MD
About this study
Official title: A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies
This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.
- Conditions
- Hematologic Malignancy
- Being tested
- Fludarabine
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineOther
Also called Total Body Irradiation
Reduced-intensity fludarabine with intermediate-dose TBI
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection
Measured: 30 days after transplant
Secondary outcomes (6)
Number of patients who are still alive as assessed by survival status at certain timepoints after transplant
Measured: 36 months after transplant
Number of patients with relapsed disease as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant
Measured: 36 months after transplant
Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant
Measured: 36 months after transplant
Number of participants who died in the absence of relapse or progression as assessed by survival status at certain timepoints after transplant
Measured: 1 year after transplant
Number of participants with responses to treatment as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant
Measured: 36 months after transplant
Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0
Measured: 90 days after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start29 Aug 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northside Hospital, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Solomon, MD, Principal investigator, BMTGA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417971
- Sponsor's protocol ID
- NSH 1347
- Status last verified
- Oct 2026
- First submitted
- 31 May 2022
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No