Back to search results

CD34+ Transplants for Leukemia and Lymphoma

This study is looking at whether a special way of processing blood stem cell transplants, using a device called the CliniMACS system, can lead to fewer problems for patients with blood cancers like acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL), or other serious blood disorders. You might receive treatments like Total Body Irradiation (TBI), Thiotepa, Cyclophosphamide (or Fludarabine), Busulfan, and Melphalan. The study aims to enroll 100 participants between 18 and 74 years old. Researchers will measure how often graft-versus-host disease (GvHD) occurs, how severe it is, and how many transplant-related deaths happen, all over a two-year period. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 100 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years to assess the incidence and severity of graft-versus-host disease and transplant-related mortality.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05565105

CD34+ Transplants for Leukemia and Lymphoma

Not Yet Recruiting
PHASE2Ages 18–74InterventionalTreatment
Guenther Koehne
~100 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:Total Body Irradiation (TBI)ThiotepaCyclophosphamideBusulfanMelphalanFludarabine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence rate of graft versus host disease (GvHD)
Measured over Two years
+4 more outcomes measured

Conditions

Leukemia, Myeloid, Acute
Leukemia, Lymphocytic, Acute

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Lymphocytic LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveChronic Myelomonocytic LeukemiaNon-Hodgkin Lymphoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Guenther Koehne, MD, PhD · PRINCIPAL_INVESTIGATOR · Baptist Health South Florida/Miami Cancer Institute

Who to contact

Guenther Koehne, MD, PhD
[email protected]
786-596-2000
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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:
Patient's age includes from ≥18 to ≤74 years old.
Patients may be of either gender or any ethnic background.
Patients must have a Karnofsky (adult) Performance Status of at least 70%
Patients must have adequate organ function measured by:

Exclusion

Female patients who are pregnant or breast-feeding
Active viral, bacterial or fungal infection
Patient seropositive for HIV-I /II; HTLV -I /II
Presence of leukemia in the CNS

What this trial measures

  • Incidence rate of graft versus host disease (GvHD)Two years

    Incidence of acute and chronic GvHD

  • Severity of diseaseTwo years

    Severity of the adverse events will be reported based on the CTCAE Version 5.

  • Incidence of transplant-related mortality (TRM)Two years

    TRM includes fatal complications resulting from the allogeneic transplant and/ or treatment regimens such as graft failure, GvHD, hemorrhages, and infections.

  • Change in overall survival (OS)Six months, one year, two years

    OS is defined as time from transplant to death or last follow-up.

  • Change in disease free survival (DFS)Six months, one year, two years

    DFS is defined as the minimum time interval of times to relapse/recurrence, to death or to the last follow- up, from the time of transplant.