T-cell Depleted Hematopoietic Stem Cell Boosts Without Conditioning for Poor Marrow Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation



Status:Terminated
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:10/11/2018
Start Date:January 21, 2015
End Date:October 25, 2017

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Phase II Trial of T-cell Depleted Hematopoietic Stem Cell Boosts Without Conditioning for Poor Marrow Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation

The purpose of this study is to see if giving the patient stem cells their original donor
(boost) after removing the T cells (T cell depleted- TCD boost) without further chemotherapy.
The investigators want to see if this can improve bone marrow function. This would also
improve the patients white blood counts, red blood counts and platelets. This may make the
patients chances of improving and surviving better. The investigators will also be looking at
the short term side effects and risks of the TCD boost.


Inclusion Criteria:

- Patients who are diagnosed with PGF are candidates for this trial.

- Patients who underwent transplant at another facility and suffer from PGF will be
eligible as well as long as a donor is available. PGF can be primary (no counts
recovery after the preparative regimen) or secondary (cytopenia after engraftment has
occurred).

- Patients with auto-immune cytopenia with auto antibodies to neutrophils or platelets
or positive Coombs test that did not respond to immunosuppressive agents within 3
months from initiation of therapy are eligible as well.

- Persistent cytopenia requiring growth factors and/or blood products AND evidence of
hypocellular BM (<25%). Persistent cytopenia (at least 4 weeks period) is defined by
presence of TWO of the following:

1. ANC <1.0x10^9/L without filgrastim support or any ANC value that requires
recurrent support by filgrastim (administered at least once a week).

2. Plt<50x10^9/L

3. Hb<8 or PRBC transfusion dependent (once every 2 weeks or more) with reticulocyte
count of < 40x10^9/L.

This criteria for persistent cytopenia and hypocellular bone marrow does not apply to
patients with auto-immune cytopenia, ONLY PGF patients

- Full donor myeloid chimerism. Patients after T cell depletion transplant can have a
significant mixed T cell chimerism and this can affect the testing of marrow
chimerism. In this case, the neutrophil chimerism will be used to determine
eligibility for this trial. Patients will be excluded if neutrophils are less than 90%
donor cells; a higher percentage of host cells could be due to relapse or impending
relapse.

- Age: pediatrics and adults patients. No age exclusion.

- Each patient must be willing to participate as a research subject and must sign an
informed consent form.

- For infections and end organs related criteria (at time of TCD boost administration)
see table in protocol.

Exclusion Criteria:

Patients will be excluded from the trial if at time of enrollment:

- Evidence of relapsed disease by morphologic, cytogenetic or molecular diagnostic
tools.

- Hypersplenism documented by imaging study (US or CT)

- Pregnant women

- Patient who underwent TCD boost without counts recovery and are considered for another
TCD boost will be treated off protocol.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Roni Tamari, MD
Phone: 212-639-5987
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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