Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection

Launched by BAYLOR COLLEGE OF MEDICINE · Aug 25, 2010

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to prepare stem cells for patients who need a stem cell transplant, particularly when they have a donor who is only a partial match. The goal is to reduce the risk of a serious complication called graft-versus-host disease (GvHD), where the donor's immune cells attack the recipient's body. By using a special technique to select and treat the stem cells from the donor, the researchers hope to make the transplant safer and more effective.

To participate in this trial, patients must be between birth and 70 years old and need an allogeneic stem cell transplant, meaning they will receive stem cells from someone else. They should not have any severe infections or other serious health issues. If you or a loved one are considering this trial, you will be closely monitored and supported throughout the process, and the treatment aims to improve the chances of recovery after the transplant.

Gender

ALL

Eligibility criteria

• • 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