Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 6 Months to 39 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests donor stem cell transplants with certain immune cells, called T cells and B cells, removed. It looks at safety, how well the treatment works, and whether it can be carried out. It is for people ages 6 months to 39 years with certain leukemias, high-risk myelodysplastic syndrome (a bone marrow disease), or lymphoma.
This study will assess the safety, efficacy, and feasibility of ⍺/β CD3+ T-cell and CD19+ B-cell depletion in allogeneic stem cell transplantation in patients with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), juvenile myelomonocytic leukemia (JMML), high risk myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) and lymphoma. Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 6 months to 39 years old.
- Have ALL, AML, JMML, CML, high-risk myelodysplastic syndrome, or Hodgkin or non-Hodgkin lymphoma that meets the study’s disease rules. These include rules about gene changes, past treatment, and how much cancer remains.
- Have no more than one active cancer. Another cancer may be allowed if the study doctors agree it will not affect the study.
- Have a suitable stem cell donor: a matched sibling, a matched unrelated person, or a partly matched relative.
- Have a score of at least 60 on the study’s scale of ability to do daily activities.
- Have lung, kidney, heart, and liver function that meets study limits, checked within 4 weeks before transplant preparation starts.
- You or your guardian must give written consent, and you must agree to follow study procedures.
- If you or your partner could become pregnant, use approved birth control during the study and avoid pregnancy for at least 8 weeks after the last study drug dose.
Who can't join
- Have an infection that is not under control.
- Had a donor stem cell transplant within the past 6 months, unless this transplant is a boost.
- Have active acute graft-versus-host disease of grade 2 or higher, a condition in which donor cells attack your body.
- Have shown that you do not follow medical care instructions.
- Cannot or will not use acceptable birth control during the study and for at least 8 weeks after the last study drug dose, if pregnancy is possible.
- Are pregnant or breastfeeding.
- Have another health problem or test result that your doctor thinks makes treatment unsafe, raises the risk of complications, or could affect study results.
- Are in prison or are being held for required treatment of a mental or physical illness.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
FL
- University of Florida · Gainesville, FL 32608Beate Greer · Study contact · 352-294-8744 · bgreer01@ufl.eduMore trials in Gainesville