Health TrialsbyHealthPanel

Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies

ConditionAllogeneic Stem Cell Transplant Recipient
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHackensack Meridian Health

About this trial

The Flu-TBI 800 trial is a prospective, single-arm, multicenter, interventional phase 2 study to evaluate whether fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy) (experimental regimen) improves the 1-year survival of allogeneic stem cell transplant recipients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ages 18-65 years.

Acute myeloid leukemia or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow;

Myelodysplastic syndrome with less than 5% blasts in the bone marrow by IHC or flow cytometry whichever is highest;

Myeloproliferative neoplasms with less than 5% blast in the marrow and peripheral blood;

Disqualifiers

Hematopoietic cell transplantation comorbidity index above 3.

Patients with a Karnofsky performance status (KPS) of <60%.

Patients with active infections or other contraindications for allogeneic stem cell transplant.

Patients who are unable or unwilling to give informed consent.

Trial design

Design model

Single group

Treatments tested in this trial

  • Fludarabine

    Drug

    Patients will receive fludarabine administered at the dose of 30 mg/m2 intravenously daily on Days -6 to -2

  • Intermediate-dose Total Body Irradiation (TBI)

    Radiation

    Patients will receive intermediate-dose total body irradiation (TBI) administered at the dose of 800 cGy in 4 total fractions, 2 fractions per day on Days -2 to -1

  • Post-transplant Cyclophosphamide (PTCy)

    Drug

    Patients will receive post-transplant cyclophosphamide (PTCy) administered at the dose of 40 mg/kg intravenously on Days +3 to +4.

  • Tacrolimus

    Drug

    Patients will receive tacrolimus administered at a dose adjusted to maintain trough levels between 5-15 ng/mL orally starting on Days +5.

  • Mycophenolate mofetil (MMF)

    Drug

    Patients will receive mycophenolate mofetil (MMF) administered at the standard dose of 15 mg/kg orally three times daily starting on Day +5 to Day +35 or per institutional guidelines.

Treatment groups

209 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS) at 1-year following treatment with fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy)

OS is defined as the time from the first dose of study treatment to the time of death due to any cause. Patients who are still alive will be censored at the date last known alive of the data cut-off date (if applicable), whichever is earlier.

Time frame
Patient status (dead or alive) will be reviewed (e.g., through patient chart review,patient phone call, etc.) up through a period of 1 year

Secondary outcomes

1

Transplant-related mortality (TRM) at 1-year following treatment with fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy)

TRM is defined as death due to causes unrelated to the underlying disease. Patients relapsing are censored as surviving at the time of relapse.

Time frame
Patient status (dead or alive) will be reviewed (e.g., through patient chart review,patient phone call, etc.) up through a period of 1 year
2

Incidence of grade III-IV acute GVHD following treatment with fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy)

Acute GVHD will be assessed using the Przepiorka criteria,13 Modified Glucksberg/Keystone criteria, and Center for International Blood and Marrow Transplant Research (CIBMTR) severity index (A-D) according to HMH's standard operating procedure (SOP), "Management of Acute Graft versus Host Disease, BMT 500 15."

Time frame
Patients will be assessed for acute GVHD symptoms weekly from day +7 until day +100. If acute GVHD symptoms remain active after day +100, weekly GVHD documentation will be encouraged until symptom(s) resolution, up through a period of 1 year
3

Incidence of chronic GVHD at 1-year following treatment with fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy)

Chronic GVHD will be assessed based on the 2014 National Institutes of Health (NIH) Consensus Conference Criteria according to HMH's SOP, "Chronic Graft Versus Host Disease, BMT 500 11."

Time frame
Patients will be assessed for chronic GVHD signs and/or symptoms at a minimum of every three months for the first year post-transplant.
4

GVHD-free, relapse-free survival (GRFS) at 1-year following treatment with fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy)

GVHD-free, relapse-free survival (GRFS) is a composite endpoint that includes grades 3-4 acute GVHD, chronic GVHD requiring systemic therapy, relapse, or death in the first post-transplant year.

Time frame
Patient status (GVHD-free, relapse-free or not) will be reviewed (e.g., throughpatient chart review, patient phone call, etc.) up through a period of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hackensack Meridian Health

Lead sponsor

Source ClinicalTrials.gov
Apply now