CD34+ Transplants for Myeloid Malignancies
A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Myeloid Malignancies
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 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 whether using the CliniMACS device to prepare donated blood stem cells leads to fewer transplant problems. It is for adults ages 18–70 with certain blood cancers or other life-threatening blood disorders that a transplant may treat.
This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–70 years old. People ages 65–70 will be studied as a separate group.
- Have a disease that can be treated with donated stem cells selected for a marker called CD34, with T cells (a type of immune cell) removed.
- Eligible diseases include certain forms or stages of acute myeloid leukemia (AML), chronic myeloid leukemia (CML), chronic myelomonocytic leukemia (CMML), or medium- to high-risk myelofibrosis (bone marrow scarring). Other life-threatening disorders may qualify.
- Have a donor who meets the study’s matching rules: an 8-of-8 match, or an unrelated donor with an allowed 7-of-8 match.
- Be able to care for yourself, with a daily activity score of at least 70%.
- Have heart, liver, kidney, and lung function that meets study limits. Your heart must pump at least 50% of its blood with each beat, and a lung gas-transfer test must be at least 50% of the expected value.
- Be willing to take part and sign a consent form.
- People of any sex, gender, or ethnic background may join.
Who can't join
- Be pregnant or breastfeeding.
- Have an infection that is not controlled, HIV, or hepatitis C. People cured of hepatitis C at least 3 years before joining may qualify.
- Have a positive hepatitis B surface antigen test. People with only hepatitis B core antibodies may qualify if no viral DNA is found and they agree to preventive medicine and monitoring every 12 weeks while taking medicines that weaken the immune system.
- Have leukemia in the brain or spinal cord.
- Have heart disease with symptoms, a heart pumping level below 50%, or severe heart failure. A heart attack, unstable chest pain, stroke, mini-stroke, or other listed heart or blood vessel disease within the past 6 months also rules you out.
- Receive a transplant without T cells removed, or have fewer than 3 million stem cells per kilogram of body weight after CD34 selection.
- Have a known reaction to any part of the CliniMACS Prodigy CD34 System.
- Have another active cancer or a past cancer, unless you have been cancer-free for at least 2 years and the study doctor thinks it is unlikely to return. Exceptions include cured cervical cancer limited to its surface, or cured basal cell or squamous cell skin cancer.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Malignant conditions or other life-threatening disorders correctable by transplant for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as: 1. AML in 1st remission-- for patients whose AML does not have "good risk" cytogenetic features (i.e., t(8;21), (q22; q22.1); RUNX1-RUNX1T1, inv16). 2. Secondary AML in 1st remission 3. AML in 1st relapse or 2nd remission 4. CML not responding adequately to TKI therapy, CML in accelerated phase or blast crisis, or CML in CR after accelerated phase or blast crisis 5. Chronic myelomonocyte leukemia: CMML-1 and CMML-2. 6. Intermediate to high-risk primary or secondary myelofibrosis * Patients aged ≥18 and ≤70 years old. Patients 65-70 years old will be examined as a separate cohort, since myeloablative regimens have been shown to be associated with increased morbidity, mortality, and toxicity in older patients, specifically, patients above 65 years of age (49). * Patients may be of either gender or any ethnic background * Patients must have an appropriately matched donor (MRD 8/8, MUD 8/8, or MMUD 7/8 \[mismatch at HLA-A, B or DR-B1 locus\]) * Patients may be of any sex, gender, or ethnic background. * Patients must have a Karnofsky (adult) Performance Status of at least 70% * Patients must have adequate organ function measured by: 1. Cardiac: asymptomatic; left ventricular ejection fraction (LVEF) at rest must be ≥50% 2. Hepatic: \< 3 × ULN AST and: \< 1.5 × ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant (e.g., AML Chloroma obstructing the biliary tree). Patients with higher bilirubin levels due to causes other than active liver disease are also eligible with Pl approval e.g., patients with PNH, Gilbert's disease or other hemolytic disorders. 3. Renal: serum creatinine: within normal range 0.7-1.3 mg/dL or if serum creatinine is outside the normal range, then CrCl \> 45 mL/min (measured or calculated/estimated via Cockcroft-Gault formula). 4. Pulmonary: asymptomatic \[but sustained DLCO ≥ 50% of predicted (corrected for hemoglobin)\]. Each patient must be willing to participate as a research subject and must sign an informed consent form. Exclusion Criteria: * Individuals who are pregnant or breast-feeding * Uncontrolled bacterial, viral, or fungal infections; or known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection 1. Patients cured of Hepatitis C for ≥3 years prior to enrollment are permitted 2. Patients with detectable hepatitis B surface antigen (HBsAg) will be excluded. Patients with viral hepatitis B core antibody (HBcAb) positivity, but absence of HBsAg, will be eligible if HBV DNA is undetectable and if they are willing to be on hepatitis B antiviral prophylaxis and undergo monitoring for HBV reactivation (every 12 weeks while on immune suppression) per institutional protocols. Patients will be referred promptly to hepatology specialist with the first detectable viral load. * Presence of leukemia in the CNS * Symptomatic cardiac disease (angina, congestive heart failure) and/or LVEF \<50%. * History of cardiovascular disease including but not limited to myocardial infarction, unstable angina, stroke, or transient ischemic attack within the 6 months prior to the initiation of study or congestive heart failure (New York Heart Association \[NYHA\] class III-IV) * Patients who subsequently receive a non-T-cell-depleted transplant * Stem cell count \<3.0 × 10\^6/kg after CD34+ selection * Known sensitivity to components of CliniMACS® Prodigy CD34 System * Have a history of other active malignancy(ies) unless the patient has been disease-free for at least 2 years and is deemed by the treating Investigator to be at low risk for recurrence of that malignancy; or the only prior cancer is curatively treated cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin.
Study sites (1)
FL
- Baptist Health Herbert Wertheim Cancer Institute · Miami, FL 33176Guenther Koehne, MD, Ph.D. · Study contact · 786-596-2000 · GuentherK@baptisthealth.netMore trials in Miami