Cytokine-Treated Veto Cells in Treating Participants With Hematologic Malignancies Following Stem Cell Transplant
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Lymphoma, Anemia, Hematology, Hematology, Hematology, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 12 - 70 |
| Updated: | 3/30/2019 |
| Start Date: | May 1, 2019 |
| End Date: | April 1, 2020 |
| Contact: | Richard Champlin |
| Email: | CR_Study_Registration@mdanderson.org |
| Phone: | 713-792-8750 |
Anti-Viral Central Memory CD8 Veto Cells in Haploidentical Hematopoietic Stem Cell Transplantation
This phase I/II trial studies how well cytokine-treated veto cells work in treating
participants with hematologic malignancies following stem cell transplant. Giving
chemotherapy and total-body irradiation before a stem cell transplant helps stop the growth
of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer
cells. When the healthy stem cells from a donor are infused into the participant, they may
help the participant's bone marrow make stem cells, red blood cells, white blood cells, and
platelets. cytokine-treated veto cells may help the transplanted donor cells to develop and
grow in recipients without causing graft-versus-host-disease (GVHD - when transplanted donor
tissue attacks the tissues of the recipient's body).
participants with hematologic malignancies following stem cell transplant. Giving
chemotherapy and total-body irradiation before a stem cell transplant helps stop the growth
of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer
cells. When the healthy stem cells from a donor are infused into the participant, they may
help the participant's bone marrow make stem cells, red blood cells, white blood cells, and
platelets. cytokine-treated veto cells may help the transplanted donor cells to develop and
grow in recipients without causing graft-versus-host-disease (GVHD - when transplanted donor
tissue attacks the tissues of the recipient's body).
PRIMARY OBJECTIVES:
I. To determine the optimal dose of anti-viral veto cells, defined as the dose which achieves
engraftment without severe graft-vs-host disease (GVHD) at 42 days after non-myeloablative
megadose T cell depleted haploidentical hematopoietic cell transplantation (HCT).
SECONDARY OBJECTIVES:
I. Toxicity. II. Response rate. III. Time to progression. IV. Infections. V. Immune
reconstitution. VI. Overall survival up to 1 year.
OUTLINE: This is a dose-escalation study of cytokine-treated veto cells.
CONDITIONING REGIMEN: Participants receive anti-thymocyte globulin (ATG) intravenously (IV)
over 4 hours on days -9 to -7 and fludarabine IV over 1 hour on days -6 to -3, then undergo
total body irradiation (TBI) on day -1.
TRANSPLANT: Participants undergo peripheral blood stem cell transplantation (PBSCT) IV over
30-60 minutes on day 0.
GVHD PROPHYLAXIS: Participants receive cyclophosphamide IV over 3 hours on days +3 and +4 and
cytokine-treated veto cells IV over 30-60 minutes on day +7.
After completion of stem cell transplant, participants are followed up once a week for 4
weeks, once a month for 3 months, and then periodically for one year.
I. To determine the optimal dose of anti-viral veto cells, defined as the dose which achieves
engraftment without severe graft-vs-host disease (GVHD) at 42 days after non-myeloablative
megadose T cell depleted haploidentical hematopoietic cell transplantation (HCT).
SECONDARY OBJECTIVES:
I. Toxicity. II. Response rate. III. Time to progression. IV. Infections. V. Immune
reconstitution. VI. Overall survival up to 1 year.
OUTLINE: This is a dose-escalation study of cytokine-treated veto cells.
CONDITIONING REGIMEN: Participants receive anti-thymocyte globulin (ATG) intravenously (IV)
over 4 hours on days -9 to -7 and fludarabine IV over 1 hour on days -6 to -3, then undergo
total body irradiation (TBI) on day -1.
TRANSPLANT: Participants undergo peripheral blood stem cell transplantation (PBSCT) IV over
30-60 minutes on day 0.
GVHD PROPHYLAXIS: Participants receive cyclophosphamide IV over 3 hours on days +3 and +4 and
cytokine-treated veto cells IV over 30-60 minutes on day +7.
After completion of stem cell transplant, participants are followed up once a week for 4
weeks, once a month for 3 months, and then periodically for one year.
Inclusion Criteria:
- Patients with a diagnosis either follicular lymphoma (FL), mantle cell lymphoma (MCL),
chronic lymphocytic leukemia (CLL), multiple myeloma (MM), Hodgkin's lymphoma (HL),
non-Hodgkin's lymphoma (NHL), chronic myeloid leukemia (CML), myelodysplastic
syndrome, myeloproliferative syndromes (MPD), acute myeloid leukemia (AML) or acute
lymphoid leukemia (ALL).
- Patients with aplastic anemia and severe immune deficiency or nonmalignant bone marrow
failure states.
- Patients with hematological malignancies must have had persistent or progressive
disease despite initial chemotherapy and must have achieved stable disease or a
partial or complete response to their most recent chemotherapy. Patients with low bulk
or indolent relapse are eligible without additional treatment. Patients with high risk
acute myeloid leukemia by European LeukemiaNet (ELN) criteria in first remission are
eligible.
- Availability of a haploidentical related donor.
- Karnofsky performance status >= 70%.
- Left ventricular ejection fraction of at least 40%.
- Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least
50% predicted value for hemoglobin concentration.
- Serum creatinine =< 1.5 mg/dl.
- Serum glutamic-pyruvic transaminase (SGPT) =< 200 IU/ml.
- Bilirubin < 1.5 mg/dl (unless Gilbert's syndrome).
- Negative pregnancy test in a woman with child bearing potential.
Exclusion Criteria:
- Human immune deficiency virus (HIV) seropositive.
- Uncontrolled infection or serious medical or psychiatric condition that would limit
tolerance to the protocol treatment.
- Active central nervous system (CNS) malignancy.
- Availability of medically eligible, human leukocyte antigen (HLA)-matched related stem
cell donor.
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Richard E. Champlin
Phone: 713-792-8750
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