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 range18 Years – 74 Years

SexALL

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

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 range18 Years – 74 Years

SexALL

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