BridgeMD
New treatment option for Hematologic Malignancy
Official title MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
ClinicalTrials.gov ID: NCT05735717
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hematologic malignancy.
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 phase II, open-label, prospective study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety/feasibility study of the investigational procedure/product.
- 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 up to 60
You may be able to join if
- Histological confirmation of hematological malignancies
- Acute leukemias
- Acute Myeloid Leukemia (AML) and related precursor neoplasms
- Favorable risk AML is defined as having one of the following:
- Acute lymphoblastic leukemia (ALL)/lymphoma
You likely can't join if
- Pregnant or breastfeeding.
- Active uncontrolled infection within 1 week of starting preparative therapy
- Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.
- Any prior autologous or allogeneic transplant
- CML blast crisis
- Active central nervous system malignancy
See the full eligibility criteria
- Histological confirmation of hematological malignancies
- Acute leukemias
- Acute Myeloid Leukemia (AML) and related precursor neoplasms
- Favorable risk AML is defined as having one of the following:
- Acute lymphoblastic leukemia (ALL)/lymphoma
- Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.
- Age 60 years of age or younger at the time of consent
- Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.
- Adequate organ function
- Pregnant or breastfeeding.
- Active uncontrolled infection within 1 week of starting preparative therapy
- Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.
- Any prior autologous or allogeneic transplant
- CML blast crisis
- Active central nervous system malignancy
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, 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, up to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, 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.