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New treatment option for Allogeneic Hematopoietic Stem Cell Transplantation
Official title Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT06028828
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, being studied as a potential treatment for allogeneic hematopoietic stem cell transplantation.
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
- This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.
- 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 70
You may be able to join if
- Male or female aged 18-70 years
- Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
- Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)
- Karnofsky performance \>70%
- Adequate major organ system function as demonstrated by:
You likely can't join if
- Inability to comply with medical recommendations or follow-up
- Pregnancy
- Active/uncontrolled bacterial or viral infection (PI is the final arbiter of this criterion.)
- Has active CNS or ocular disease involvement within 3 months
- Patients with primary CNS lymphoma
- Patients who require modifications of the conditional regimen
See the full eligibility criteria
- Male or female aged 18-70 years
- Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
- Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)
- Karnofsky performance \>70%
- Adequate major organ system function as demonstrated by:
- Serum creatinine clearance equal or more than 50 ml/min (calculated with Cockroft-Gault formula).
- Bilirubin equal or less than 1.5 mg/dl except for Gilbert's disease. ALT or AST equal or less than 200 IU/ml for adults. Conjugated (direct) bilirubin less than 2x upper limit of normal.
- Left ventricular ejection fraction equal or greater than 40%.
- Diffusing capacity for carbon monoxide (DLCO) equal or greater than 50% predicted corrected for hemoglobin.
- Ability to understand and the willingness to sign a written informed consent. a. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and...
- Inability to comply with medical recommendations or follow-up
- Pregnancy
- Active/uncontrolled bacterial or viral infection (PI is the final arbiter of this criterion.)
- Has active CNS or ocular disease involvement within 3 months
- Patients with primary CNS lymphoma
- Patients who require modifications of the conditional regimen
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, 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.