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New treatment option for Allogeneic Stem Cell Transplant Recipient
Official title Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies
ClinicalTrials.gov ID: NCT07214688
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for allogeneic stem cell transplant recipient.
Also referred to as Fludara, Oforta.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients ages 18-65 years.
- Patients with a diagnosis of one of the following hematologic malignancies:
- 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;
You likely can't join if
- 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.
- Patients who have received a prior allogeneic transplant.
- Patients who are unable to comply with follow-up visits and treatment plans.
See the full eligibility criteria
- Patients ages 18-65 years.
- Patients with a diagnosis of one of the following hematologic malignancies:
- 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;
- Acute lymphoblastic leukemia in CR (CIBMTR criteria); or Lymphoma in CR (CIBMTR criteria).
- Patients who are eligible for allogeneic stem cell transplant per Transplant Program SOPs.
- Patients with a Karnofsky performance status (KPS) of ≥60%.
- Patients with adequate organ function defined by:
- Cardiac: LVEF ≥50%
- Pulmonary: DLCO ≥50% of predicted
- Hepatic: Bilirubin ≤1.5x ULN, ALT/AST ≤2.5x ULN
- Renal: Creatinine clearance ≥50 mL/min
- All participants of reproductive potential must use effective contraception following allogeneic hematopoietic stem cell transplantation (allo-HSCT), in accordance with guidelines from the American Society for...
- For Male Participants: ○ Male participants must use effective contraception for at least 12 months after transplant, and longer if receiving immunosuppressive or cytotoxic medications. Chemotherapy and radiation can...
- For Female Participants:
- Female participants of childbearing potential are required to use highly effective contraception for a minimum of 12 to 24 months post-transplant, or longer if still receiving immunosuppressive or teratogenic therapy...
- A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not...
- Patients with a suitable donor for allogeneic stem cell transplant defined by:
- Matched sibling donors willing to donate mobilized peripheral blood (PBSC) or bone marrow (BM), meeting all institutional criteria for donation;
- Unrelated donors at \>7/8 (i.e., mismatched at only one of the HLA-A, HLA-B, HLA-C, and HLA-DRB1 loci) willing to donate mobilized PBSC or BM, and medically eligible to donate cells according to National Marrow Donor...
- Patients who are able to comply with follow-up visits and treatment plans.
- Patients who are able to give informed consent.
- 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.
- Patients who have received a prior allogeneic transplant.
- Patients who are unable to comply with follow-up visits and treatment plans.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Hackensack, New Jersey, United States
- Neptune City, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Hackensack, New Jersey, United States; Neptune City, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.