Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New transplant method aims to cut dangerous side effects in blood cancer patients

NCT ID NCT05800210

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a stem cell transplant method that removes certain immune cells (T-cells and B-cells) from the donor cells. The goal is to reduce graft-versus-host disease, a serious complication where donor cells attack the patient's body. The trial includes 20 children and young adults with blood cancers like leukemia and lymphoma. Researchers will compare the rate of severe graft-versus-host disease to historical data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
stem cell transplant with T-cell and B-cell removal
What this could lead to
If successful, this could offer a safer stem cell transplant option for blood cancer patients, reducing severe side effects while controlling the disease.
What could go wrong
This is a small, early-phase study with only 20 participants, so results may not apply broadly. The procedure carries risks like infection or graft failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 39 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: A. Children, Adolescents, Young adults (ages 6 months to ≤39 years) with the following diseases may be eligible: i. ALL 1. ALL high risk including one or more of the following: (t(9;22) or 11q23 chromosomal abnormality, primary induction failure (≤15% blasts at time of registration), mixed phenotype acute leukemia (MPAL), persistent MRD (≥0.01% by flow or persistent abnormal karyotype detected by cytogenetics) or hypodiploidy (≤44 chromosomes)) in first remission 2. ALL in second remission and beyond ii. AML 1. History of AML induction/reinduction Failure (≤15% blasts at time of registration) 2. AML in CR1 with poor cytogenetics (i.e., 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others) 3. AML with persistent minimal residual disease (MRD) in CR1(≥0.01% on flow or persistent abnormal karyotype detected by cytogenetics) 4. AML CR2 or beyond 5. AML in refractory relapse but ≤15% bone marrow leukemia blasts 6. Therapy-related AML iii. Juvenile MyeloMonocytic Leukemia (JMML) 1. JMML in CR1 without CBL mutation 2. JMML with recurrence of disease with or without CBL mutation 3. JMML CR2 or beyond iv. Chronic Myeloid Leukemia (CML) 1\. CML in CR with regard to blast crisis v. High Risk Myelodysplastic syndrome (MDS) vi. Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL) 1. HL or NHL with a history of induction failure 2. HL or NHL in PR1 or PR2 3. HL or NHL in CR2 or subsequent remission B. Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included). C. HLA-matched (5-6/6) sibling donor, matched (8-10/10) unrelated donor available for stem cell donation, haplo-identical related donor (at least one full haplotype must be matched). D. Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients \>16 years of age and Lansky scores for patients ≤16 years of age. E. Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as: i. Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 60% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen. ii. Renal: Creatinine clearance or radioisotope GFR ≥60 mL/min/1.73 m2 or a serum creatinine based on age/gender iii. Cardiac: Shortening fraction of ≥ 27% by echocardiogram) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA). iv. Hepatic: SGOT (AST) or SGPT (ALT) \< 5 x upper limit of normal (ULN) for age. Conjugated bilirubin \< 2.5 mg/dL, unless attributable to Gilbert's Syndrome. F. Written informed consent obtained from the subject or guardian and the subject agrees to comply with all the study-related procedures. G. Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 8 weeks after the last dose of study drug to minimize the risk of pregnancy. H. Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 8 weeks following the last dose of study drug. Exclusion Criteria: A. Patients with documented uncontrolled infection B. Patients who have received allogeneic hematopoietic stem cell transplantation within 6 months, unless being done as a boost. C. Patients with active ≥Grade 2 aGVHD. D. Demonstrated lack of compliance with medical care. E. Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 8 weeks after the last dose of study drug. F. Females who are known to be pregnant or breastfeeding. G. History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. H. Prisoners or subjects who are incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute lymphoblastic leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32608, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.