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New treatment option for Hematologic Malignancy
Official title CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
ClinicalTrials.gov ID: NCT06326463
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.
Also referred to as Fludara.
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 study participant has one of the following blood cancers: acute myelogenous leukemia (AML)/myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after treatment (relapse).
- Phase 1: an early, usually small safety study
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 21
You may be able to join if
- Age ≤21 years old Relapsed/refractory CD70+ hematological malignancy Relapsed disease: Patients developing recurrent disease after a prior complete...
- Relapsed/refractory CD70+ AML or MDS:
- Relapsed disease that is CD70 positive
- Refractory disease that is persistent despite 3 cycles of chemotherapy
- Relapsed/refractory CD70+ B-cell ALL:
You likely can't join if
- Known primary immunodeficiency
- Known history of HIV positivity
- Severe intercurrent bacterial, viral or fungal infection
- History of hypersensitivity to cornstarch or hydroxyethyl starch
- Patients with acute promyelocytic leukemia (APL)
- Known contraindication to protocol defined lymphodepleting
See the full eligibility criteria
- Age ≤21 years old Relapsed/refractory CD70+ hematological malignancy Relapsed disease: Patients developing recurrent disease after a prior complete remission (CR) Refractory disease: Patients with persistent disease...
- Relapsed/refractory CD70+ AML or MDS:
- Relapsed disease that is CD70 positive
- Refractory disease that is persistent despite 3 cycles of chemotherapy
- Relapsed/refractory CD70+ B-cell ALL:
- Relapsed disease that is CD70 positive and CD19 negative/dim or patients otherwise ineligible for CD19-directed therapies including:
- Patients in 2nd or greater relapse
- Patients with relapse after allogeneic HSCT
- Relapsed/refractory CD70+ T-cell ALL:
- Relapsed /refractory disease that is CD70 positive
- Mixed Phenotype Acute Leukemia (MPAL):
- Relapsed/refractory that is CD70 positive
- Relapsed/refractory CD70+ lymphoma:
- Relapsed disease that is CD70 positive and CD19 negative/dim or patients otherwise ineligible for CD19-directed therapies including:
- Patients in 2nd or greater relapse
- Patients with relapse after allogeneic HSCT Estimated life expectancy of \>12 weeks Karnofsky or Lansky (age- dependent) performance score ≥50 Patients with a history of prior allogeneic HCT must be clinically recovered...
- Known primary immunodeficiency
- Known history of HIV positivity
- Severe intercurrent bacterial, viral or fungal infection
- History of hypersensitivity to cornstarch or hydroxyethyl starch
- Patients with acute promyelocytic leukemia (APL)
- Known contraindication to protocol defined lymphodepleting
- chemotherapy regimen of Fludarabine/cyclophosphamide
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, 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 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, 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.