Recruiting

CD34-Selection

Sponsor:

Baylor College of Medicine

Code:

NCT01189786

Conditions

Stem Cell Transplant

Allogeneic

Eligibility Criteria

Sex: All

Age: 0 - 70

Healthy Volunteers: Not accepted

Interventions

CliniMACS CD34 Reagent system

Study Details

Brief summary:

Participants are being asked to take part in this study because treatment of his or her disease requires a stem cell transplant. Stem cells or "mother" cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation. Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother) for the participant and his or her disease does not permit enough time to identify another donor (like someone from a registry list that is not his or her relative) or another suitable donor has not been identified. However, a close relative of the patient has been identified whose stem cells are not a perfect match, but can be used.

Alternatively, the patient may have already received a stem cell transplant but have evidence of mixed chimerism, which means some of the patient's own bone marrow cells are present, rather than all of the donor's cells. This may lead to an increased risk of the disease coming back. Or, the patient may have all donor cells but his or her bone marrow is not working very well, which may lead to frequent blood or platelet (cells that help in clotting blood) transfusions or infection.

Regardless of the reason, it may be necessary to isolate stem cells from a haploidentical (half-match) donor in order to provide bone marrow function. Because the stem cells from the donor are only half-matched to the participant, the risk of graft-versus-host disease (GvHD) is very high. GvHD is a complication after transplant caused by donor T cells (graft) that attack the transplant recipient, and this complication can cause death after transplant. Thus, it is important that the donor's blood cells are treated to minimize cells that are most likely to attack the host's tissues. This is done by using a special device to capture the CD34+ stem cells from the donor's stem cell product prior to giving the cells to the host. This method minimizes the donor T cells, which are responsible for causing GvHD.

Purpose: In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure, investigators would like to specially treat the donor's blood cells to minimize the cells that are most likely to attack the patient's tissues.

Conditions

Stem Cell Transplant

Allogeneic

Study ID

NCT01189786

Start date

Oct, 2010

Status verified date

Nov, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70

Healthy Volunteers: Not accepted

Inclusion criteria for Stem Cell Transplant WITH Conditioning (COHORT 1)

1. Patient requiring allogeneic SCT
2. Age between birth and 70 years
3. Patient and/or responsible person able to understand and sign consent

Exclusion criteria for Stem Cell Transplant WITH Conditioning (COHORT 1)

1. Active, acute GvHD > grade II or extensive, chronic GvHD
2. Severe life, threatening infection
3. Pulmonary dysfunction (FEV1, FVC or DLCO 40% of predicted or 3 SD below normal)
4. Cardiac dysfunction (LVSF less than 25%)
5. Psychiatric disturbance
6. Lansky or Karnofsky score < 50%
7. The presence of severe hepatic disease (direct bilirubin >3x upper limit of normal and AST > 5x upper limit of normal).
8. Creatinine > 3x normal
9. Known HIV Positivity
10. Pregnancy

Inclusion Criteria for CD34+ Topoff WITHOUT conditioning (COHORT 2)

1. Allogeneic SCT Recipient requiring additional cellular therapy
2. Age between birth and 70 years
3. Patient and/or responsible person able to understand and sign consent
4. At least ONE of the following must be answered YES for a patient to be eligible to receive CD34+ topoff:

1. Evidence of mixed chimerisms (less than 95% donor cells)
2. Evidence of poor bone marrow function (bone marrow cellularity less than 50% with at least one cytopenia)
3. Relapsed or persistent disease

Exclusion criteria for CD34+ Topoff WITHOUT conditioning (COHORT 2)

1. Active, acute GvHD > grade II or extensive, chronic GvHD
2. Severe life, threatening infection
3. Known HIV positivity
4. Pregnancy

Inclusion Criteria for CD34+ Topoff WITH conditioning (COHORT 3)

1. Allogeneic SCT Recipient requiring additional cellular therapy
2. Age between birth and 70 years
3. Patient and/or responsible person able to understand and sign consent
4. At least ONE of the following must be answered YES for a patient to be eligible to receive CD34+ topoff:

1. Evidence of mixed chimerisms (less than 95% donor cells)
2. Evidence of poor bone marrow function (bone marrow cellularity less than 50% with at least one cytopenia)
3. Relapsed or persistent disease

Exclusion criteria for CD34+ Topoff WITH Conditioning (COHORT 3)

1. Active, acute GVHD > grade II or extensive, chronic GvHD
2. Severe life, threatening infection
3. Pulmonary disfunction (FEV1, FVC or DLCO 40% of predicted or 3 SD below normal)
4. Cardiac dysfunction (LVSF less than 25%)
5. Psychiatric disturbance
6. Lansky or Karnofsky score < 50%
7. The presence of severe hepatic disease (direct bilirubin > 3x upper limit of normal and AST > 5x upper limit of normal)
8. Creatinine > 3x normal
9. Known HIV positivity
10. Pregnancy

Study Design

Enrollment

241 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 2: CD34+ cells as a top off Without Conditioning

Cohort 2 consists of patients needing additional CD34+ stem cells collected by 'CliniMACS CD34 Reagent system' as a "topoff" without the need for additional conditioning prior to the infusion. These patients who have already received SCT and are receiving CD34+ cells from their original donor for poor graft function, declining chimerism or disease relapse.

experimental: Cohort 1: CD34+ Cells for transplant

Cohort 1 consists of patients receiving CD34+ selected peripheral blood stem cell transplant with a preceding conditioning regimen (chemotherapy with, or without, radiation). The stem cells will then be separated out from the white blood cells by a special machine- called a CliniMACS CD34 Reagent System in the laboratory.

experimental: Cohort 3: CD34+ cells as a top off With Conditioning

Cohort 3 consists of patients needing additional CD34+ stem cells collected by 'CliniMACS CD 34+ Reagent System' as a "topoff" with the need for additional conditioning prior to the infusion. These patients who have already received SCT with conditioning and are receiving CD34+ cells from their original donor for poor graft function, declining chimerism or disease relapse.

Interventions

CliniMACS CD34 Reagent system

A special machine that separates out the donor cells that have been mixed with a special protein, CD34 antibody, that binds to the stem cells from the white blood cells.

Primary outcome measure

  • For Cohort 1: the rate of primary engraftment 50 days post SCT [ Time Frame: 50 days ]
  • For Cohort 2 (Without Conditioning) and Cohort 3 (With Conditioning): The total incidence of overall acute GvHD (greater than or equal to grade 3) [ Time Frame: 100 days ]

Central Contacts and Locations

Central contacts

Robert Krance, MD

832-824-4661rakrance@txch.org

Marlen Dinu

832-824-4881mxdinu@txch.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Robert Krance, MD

832-824-4661rakrance@txch.org

Marlen Dinu

832-824-4881mxdinu@txch.org

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Robert Krance, MD

832-824-4661rakrance@txch.org

Marlen Dinu

832-824-4881mxdinu@txch.org

More Information

Sponsor

Baylor College of Medicine

Last update posted

Dec 3, 2025

Last verified

Nov, 2025

Keywords

  • Haploidentical Stem Cell Transplant
  • CD34+ Selection
  • CliniMACS CD34 Reagent system

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2025-12-03.