Not Yet RecruitingPhase 2

CD34+ Transplants for Leukemia and Lymphoma

United States100 participantsStarted 2026-06

Plain-language summary

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.

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. AML in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16).
. Secondary AML in 1st remission
. AML in 1st relapse or 2nd remission
. ALL/CLL in patient remission clinical or molecular features indicating a high risk for relapse; or ALL/CLL 2nd remission
. CML failing to respond to or not tolerating imatinib or dasatinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.
. Non-Hodgkin's lymphoma with chemo responsive disease in any of the following categories:
. Intermediate or high-grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.
. Any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence rate of graft versus host disease (GvHD)

Timeframe: Two years

Severity of disease

Timeframe: Two years

Incidence of transplant-related mortality (TRM)

Timeframe: Two years

Change in overall survival (OS)

Timeframe: Six months, one year, two years

Change in disease free survival (DFS)

Timeframe: Six months, one year, two years

Trial details

NCT IDNCT05565105

SponsorGuenther Koehne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2033-06

Contact for this trial

Guenther Koehne, MD, PhD

786-596-2000 GuentherK@baptisthealth.net

View on ClinicalTrials.gov More Leukemia, Myeloid, Acute trials

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. AML in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16).
. Secondary AML in 1st remission
. AML in 1st relapse or 2nd remission
. ALL/CLL in patient remission clinical or molecular features indicating a high risk for relapse; or ALL/CLL 2nd remission
. CML failing to respond to or not tolerating imatinib or dasatinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.
. Non-Hodgkin's lymphoma with chemo responsive disease in any of the following categories:
. Intermediate or high-grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.
. Any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant.

What they're measuring

Incidence rate of graft versus host disease (GvHD)

Timeframe: Two years

Severity of disease

Timeframe: Two years

Incidence of transplant-related mortality (TRM)

Timeframe: Two years

Change in overall survival (OS)

Timeframe: Six months, one year, two years

Change in disease free survival (DFS)

Timeframe: Six months, one year, two years