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NCT Number: NCT05417971

Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

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.

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Key information

Conditions

Hematologic Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caitlin Guzowski

Atlanta, Georgia, 30342, United States

Location status: Recruiting

Location contact

Asad Bashey, MD

SUB_INVESTIGATOR

Caitlin Guzowski, MBA, MHA

CONTACT

[email protected]

404-851-8523

H. Kent Holland, MD

SUB_INVESTIGATOR

Lawrence E Morris, MD

SUB_INVESTIGATOR

Lizamarie Bachier-Rodriguez, MD

SUB_INVESTIGATOR

Melhem Solh, MD

PRINCIPAL_INVESTIGATOR

Scott Solomon, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine

Other

Reduced-intensity fludarabine with intermediate-dose TBI

Other names: Total Body Irradiation

Primary outcomes

  1. Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection

    Time frame: 30 days after transplant

Secondary outcomes

  1. Number of patients who are still alive as assessed by survival status at certain timepoints after transplant

    Time frame: 36 months after transplant

  2. Number of patients with relapsed disease as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant

    Time frame: 36 months after transplant

  3. Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant

    Time frame: 36 months after transplant

  4. Number of participants who died in the absence of relapse or progression as assessed by survival status at certain timepoints after transplant

    Time frame: 1 year after transplant

  5. Number of participants with responses to treatment as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant

    Time frame: 36 months after transplant

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0

    Time frame: 90 days after transplant

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Guzowski

CONTACT

[email protected]

404-851-8523

Stacey Brown

CONTACT

[email protected]

404-480-7965

Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 14, 2022
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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