TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:3/31/2019
Start Date:March 10, 2016
End Date:August 1, 2019

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A Pilot Study to Assess Engraftment Using CliniMACS TCR-α/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Progenitor Cell Transplantation in Patients With Relapsed Lymphoma

To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell
and CD19 cell depletion using HLA haploidentical donors for peripheral blood stem cell
transplant in relapsed lymphoma.

Assess incidence of acute GVHD (Graft versus Host Disease), chronic GVHD, graft failure rate,
treatment related mortality rate, progression free survival and overall survival of patients.

The stem cell product will be processed using an investigational Miltenyi cell selection
device/system that removes the alpha/beta T-cells and CD19+ cells, immune system cells that
are more likely to cause GVHD.


Inclusion Criteria:

- Patients must meet one of the following disease criteria within 24 months of
registration. Salvage therapy is allowed between the patient meeting one of the below
criterion and registration. Patients will be considered eligible regardless of their
current disease status (i.e. complete remission, partial remission, stable disease,
progressive disease) unless otherwise noted below as long as one of the below
criterion has been met within the previous 24 months:

- Relapsed/refractory Hodgkin lymphoma after autologous stem cell transplantation

- Relapsed/refractory Hodgkin lymphoma, deemed ineligible for autologous stem cell
transplantation due to refractory disease

- Relapsed/refractory diffuse large B cell lymphoma after autologous stem cell
transplantation (history of transformed lymphoma is acceptable). Disease must be
in at least complete remission or partial remission with the use of salvage
therapy before study treatment commences.

- Relapsed/refractory diffuse large B cell lymphoma, deemed ineligible for
autologous stem cell transplantation due to refractory disease (history of
transformed lymphoma is acceptable). Disease must be in at least complete
remission or partial remission with the use of salvage therapy before study
treatment commences.

- Relapsed/refractory T cell lymphoma relapsed after at least 1 prior line of
therapy

- Relapsed/refractory follicular lymphoma relapsed after at least 1 prior line of
therapy

- Relapsed/refractory mantle cell lymphoma relapsed after at least 1 prior line of
therapy

- Relapsed/refractory small lymphocytic lymphoma/chronic lymphocytic leukemia
relapsed after at least 1 prior line of therapy

- Relapsed/refractory non-Hodgkin Lymphoma, if not specified above, relapsed after
at least 1 prior line of therapy

- Karnofsky score of 60% or better ("Requires occasional assistance, but is able to care
for most of his/her needs").

- Pulmonary: DLCO (corrected for hemoglobin) > 40%; and FEV1 > 50%

- Cardiac: EF ≥ 50%. No uncontrolled angina or active cardiac symptoms consistent with
congestive heart failure (class III or IV), by the New York Heart Association
criteria. No symptomatic ventricular arrhythmias or ECG evidence of active ischemia.
No evidence by echocardiography of severe valvular stenosis or regurgitation.

- Renal: estimated GFR by MDRD formula > 40 mL/min/1.73m2

- Women of child bearing potential must have a negative serum or urine pregnancy test
within 14 days prior to study registration and agree to use adequate birth control
during study treatment. A female of childbearing potential (FCBP) is a sexually mature
female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has
not been naturally postmenopausal for at least 24 consecutive months (i.e., has had
menses at any time in the preceding 24 consecutive months).

- Voluntary written consent

Exclusion Criteria:

- Active CNS lymphoma within two weeks of registration. Patients with a history of CNS
involvement must have adequate treatment as defined by at least two negative spinal
fluid assessments separated by at least one week. (Otherwise LP is not required if no
clinical suspicion or evidence of CNS involvement.) Patients who have received cranial
radiation therapy must still be eligible to receive total lymphoid irradiation to 7
Gy.

- New or active infection as determined by fever, unexplained pulmonary infiltrate or
sinusitis on radiographic assessment. Infections diagnosed within 4 weeks of
registration must be determined to be controlled or resolving prior to treatment.

- Presence of HIV, or active hepatitis A, B, or C infection

- Allergy or hypersensitivity to agents used within the treatment protocol.

- For an indolent lymphoma histology (follicular lymphoma, SLL/CLL) or mantle cell
lymphoma, the patient should not have an HLA-matched sibling, who would be an eligible
donor, available.

- History of prior mediastinal radiation

- Reported illicit drug use

- Vulnerable population groups, i.e., prisoners, those lacking consent capacity,
non-English speaking, illiterate, pregnant females.
We found this trial at
1
site
600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
Phone: 800-622-8922
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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mi
from
Madison, WI
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