Status:
RECRUITING
Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Stem Cell Transplant
Allogeneic
Eligibility:
All Genders
Up to 70 years
Phase:
NA
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 l...
Detailed Description
Participation in this project will last approximately one year with follow-up exams. Before treatment can begin, stem cells will be collected from the donor (a close relative) that has been selected ...
Eligibility Criteria
Inclusion
- Inclusion criteria for Stem Cell Transplant WITH Conditioning (COHORT 1)
- Patient requiring allogeneic SCT
- Age between birth and 70 years
- Patient and/or responsible person able to understand and sign consent
- Exclusion criteria for Stem Cell Transplant WITH Conditioning (COHORT 1)
- Active, acute GvHD \> grade II or extensive, chronic GvHD
- Severe life, threatening infection
- Pulmonary dysfunction (FEV1, FVC or DLCO 40% of predicted or 3 SD below normal)
- Cardiac dysfunction (LVSF less than 25%)
- Psychiatric disturbance
- Lansky or Karnofsky score \< 50%
- The presence of severe hepatic disease (direct bilirubin \>3x upper limit of normal and AST \> 5x upper limit of normal).
- Creatinine \> 3x normal
- Known HIV Positivity
- Pregnancy
- Inclusion Criteria for CD34+ Topoff WITHOUT conditioning (COHORT 2)
- Allogeneic SCT Recipient requiring additional cellular therapy
- Age between birth and 70 years
- Patient and/or responsible person able to understand and sign consent
- At least ONE of the following must be answered YES for a patient to be eligible to receive CD34+ topoff:
- Evidence of mixed chimerisms (less than 95% donor cells)
- Evidence of poor bone marrow function (bone marrow cellularity less than 50% with at least one cytopenia)
- Relapsed or persistent disease
- Exclusion criteria for CD34+ Topoff WITHOUT conditioning (COHORT 2)
- Active, acute GvHD \> grade II or extensive, chronic GvHD
- Severe life, threatening infection
- Known HIV positivity
- Pregnancy
- Inclusion Criteria for CD34+ Topoff WITH conditioning (COHORT 3)
- Allogeneic SCT Recipient requiring additional cellular therapy
- Age between birth and 70 years
- Patient and/or responsible person able to understand and sign consent
- At least ONE of the following must be answered YES for a patient to be eligible to receive CD34+ topoff:
- Evidence of mixed chimerisms (less than 95% donor cells)
- Evidence of poor bone marrow function (bone marrow cellularity less than 50% with at least one cytopenia)
- Relapsed or persistent disease
- Exclusion criteria for CD34+ Topoff WITH Conditioning (COHORT 3)
- Active, acute GVHD \> grade II or extensive, chronic GvHD
- Severe life, threatening infection
- Pulmonary disfunction (FEV1, FVC or DLCO 40% of predicted or 3 SD below normal)
- Cardiac dysfunction (LVSF less than 25%)
- Psychiatric disturbance
- Lansky or Karnofsky score \< 50%
- The presence of severe hepatic disease (direct bilirubin \> 3x upper limit of normal and AST \> 5x upper limit of normal)
- Creatinine \> 3x normal
- Known HIV positivity
- Pregnancy
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT01189786
Start Date
October 1 2010
End Date
November 1 2027
Last Update
December 3 2025
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030