Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant



Status:Active, not recruiting
Conditions:Breast Cancer, Ovarian Cancer, Cancer, Cancer, Brain Cancer, Blood Cancer, Lymphoma, Orthopedic, Women's Studies, Hematology
Therapuetic Areas:Hematology, Oncology, Orthopedics / Podiatry, Reproductive
Healthy:No
Age Range:Any
Updated:6/22/2018
Start Date:May 2003

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Pentostatin and Donor Lymphocyte Infusion for Low Donor T-cell Chimerism After Hematopoietic Cell Transplantation - A Multi-center Trial

This phase II trial studies pentostatin and donor lymphocyte infusion in preventing graft
rejection in patients who have undergone donor stem cell transplant. Giving pentostatin and
an infusion of the donor's T cells (donor lymphocyte infusion) after a donor stem cell
transplant may stop the patient's immune system from rejecting the donor's stem cells. The
donated stem cells may replace the patient's immune cells and help destroy any remaining
cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can
also make an immune response against the body's normal cells. Giving pentostatin before donor
lymphocyte infusion may stop this from happening.

PRIMARY OBJECTIVES:

I. To assess the safety and efficacy of the combined use of pentostatin and donor lymphocyte
infusion (DLI) in patients with low or falling donor T-cell chimerism to prevent graft
rejection after transplantation both from matched related donors (MRDs) or unrelated donors
(URDs).

SECONDARY OBJECTIVES:

I. To determine the incidence of graft-versus-host disease (GvHD) infections and disease
response, if persistent disease is present.

OUTLINE: This is a dose-escalation study of donor lymphocyte infusion.

GROUP I: Patients receive pentostatin intravenously (IV) over 20-30 minutes on day -2 and DLI
over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same
cluster of differentiation (CD)3-dose at least 4 weeks if persistent donor T-cells are
documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status
is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

GROUP II (initiated if patients in group I do not achieve sustained engraftment and improved
chimerism): Patients receive treatment as in group I. Patients also receive cyclosporine
orally (PO) twice daily (BID) on days -3 to 56 and mycophenolate mofetil PO once daily (QD)
on days 0 to 27. Treatment continues in the absence of GvHD.

After completion of study treatment, patients are followed up every 6 months for 2 years and
then annually thereafter.

Inclusion Criteria:

- Patients having received a preceding allogeneic transplantation from either a human
leukocyte antigen (HLA)-matched related or unrelated donor are eligible for this
protocol

- Related donor: HLA genotypically identical at least at one haplotype and may be
phenotypically or genotypically identical at the allele level at HLA A, B, C,
DRB1, and DQB1

- Unrelated donor who are prospectively:

- Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR

- Only a single allele disparity will be allowed for HLA-A, B, or C as defined
by high resolution typing

- Patients with less than 50% donor CD3 peripheral blood chimerism on two separate,
consecutive evaluations; the two evaluations must be at least 14 days apart OR
patients with absolute decreases of donor CD3 peripheral blood chimerism of >= 20% if
the second test shows < 50% donor CD3 cells; the two evaluations must be at least 14
days apart

- Patients with evidence of disease are only eligible if the disease is stable (or
persistent) in comparison to the status prior to transplantation

- Patients must be tapered off systemic steroids to a dosage of less than or equal to
0.25 mg/kg/day

- Patients must have persistent donor CD3 cells (>= 5% donor CD3 cells by a
deoxyribonucleic acid [DNA]-based assay that compares the profile of amplified
fragment length polymorphisms [ampFLP] [or fluorescent in situ hybridization (FISH)
studies or variable number of tandem repeats (VNTR)])

- DONOR: Alternatively to a fresh unmodified leukapheresis product, previously collected
cryopreserved peripheral blood stem cells (PBSC) after mobilization with G-CSF or
cryopreserved unmodified leukapheresis product from the original donor can be used; if
cryopreserved product is not available, the following criteria apply for the DLI
product:

- DONOR: Original donor of hematopoietic cell transplantation

- DONOR: Donor must give consent to leukapheresis

- DONOR: Donor must have adequate veins for leukapheresis or agree to placement of
central venous catheter (femoral or subclavian)

- DONOR: Donor must be medically fit to undergo the apheresis procedure (institutional
guidelines for apheresis)

Exclusion Criteria:

- Current grade II to IV acute GVHD or extensive chronic GVHD

- Karnofsky score < 50%

- Pediatric criteria

- Lansky play-performance score < 40

- Evidence of relapse or progression of disease after transplantation

- Prior recipient of cord blood

- DONOR: Donors who are not suitable for medical reasons to donate peripheral blood
mononuclear cells (PBMC) by continuous centrifugation according to the criteria of the
American Association of Blood Banks (AABB)

- DONOR: Pregnancy

- DONOR: Human immunodeficiency virus (HIV) or human T-lymphotrophic virus (HTLV)
infection

- DONOR: Recent immunization may require a delay
We found this trial at
5
sites
1660 South Columbian Way
Seattle, Washington 98108
(206) 762-1010
VA Puget Sound Health Care System With a reputation for excellence, innovation and extraordinary care...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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8th Ave & C St
Salt Lake City, Utah 84143
(801) 408-1100
LDS Hospital LDS Hospital provides clinical excellence to our community in a wide range of...
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Seattle, WA
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Torino, 10126
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