Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any - 70 |
| Updated: | 5/2/2018 |
| Start Date: | October 2010 |
| End Date: | November 2021 |
| Contact: | Robert Krance, MD |
| Email: | rakrance@txch.org |
| Phone: | 832-824-4661 |
Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection (EXCESS)
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.
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.
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 as the best match for the participant. White blood cells will be
collected from the donor. The cells will then be mixed with a special protein, called a CD34
antibody, that binds to the stem cells, which will then be separated out from the white blood
cells by a special machine- called a CliniMACS CD34 Reagent System in the laboratory. This is
an investigational device that is not approved by the FDA. Although this device is not
approved for use in this country, it has been in use for years and is approved in other
countries. The stem cells will be collected and frozen before they will be given to the
participant.
On about days 28, 100 and 365 after the transplant, the participant will have the same
tests/evaluations since the time of transplant; however, the participant will also have a
bone marrow aspirate. This is where samples of bone marrow are taken to evaluate the
participant's disease and Graft vs. Host Disease (GvHD) status. For patients who do not
develop GvHD, they may have an additional bone marrow aspirate about a year after transplant.
In addition, for purposes of the study, health-related information will be collected for a
year from the time of stem cell infusion. This will be used to determine survival, relapse,
infections and GvHD that may occur following transplant.
Before treatment can begin, stem cells will be collected from the donor (a close relative)
that has been selected as the best match for the participant. White blood cells will be
collected from the donor. The cells will then be mixed with a special protein, called a CD34
antibody, that binds to the stem cells, which will then be separated out from the white blood
cells by a special machine- called a CliniMACS CD34 Reagent System in the laboratory. This is
an investigational device that is not approved by the FDA. Although this device is not
approved for use in this country, it has been in use for years and is approved in other
countries. The stem cells will be collected and frozen before they will be given to the
participant.
On about days 28, 100 and 365 after the transplant, the participant will have the same
tests/evaluations since the time of transplant; however, the participant will also have a
bone marrow aspirate. This is where samples of bone marrow are taken to evaluate the
participant's disease and Graft vs. Host Disease (GvHD) status. For patients who do not
develop GvHD, they may have an additional bone marrow aspirate about a year after transplant.
In addition, for purposes of the study, health-related information will be collected for a
year from the time of stem cell infusion. This will be used to determine survival, relapse,
infections and GvHD that may occur following transplant.
Inclusion criteria: for Stem Cell Transplant WITH Conditioning (COHORT 1)
The following must be answered YES for a patient to eligible to participate in study:
- 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)
The following must be answered NO for a patient to be eligible to participate in study:
- 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)
The following must be answered YES for a patient to be eligible to participate in study:
- 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 of poor bone marrow function (bone marrow cellularity less than 50% with
at least one cytopenia)
- Relapsed disease
Exclusion criteria: for CD34+ Topoff WITHOUT conditioning (COHORT 2)
The following must be answered NO for a patient to be eligible to participate in study:
- Active, acute GvHD > grade II or extensive, chronic GvHD
- Severe life, threatening infection
Note: Patients on a clinical treatment protocol, such as MOHEL or HIMSUM are still eligible
to receive CD34+ stem cells on this protocol.
We found this trial at
2
sites
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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