drugset / Trial / NCT01523223
Donor Peripheral Stem Cell Transplant in Treating Patients With Hematolymphoid Malignancies
NaSingle-groupOpen-labelTreatment
Summary
This phase 1 trial studies the side effects and the best dose of donor CD8+ memory T-cells in treating patients with hematolymphoid malignancies. Giving low dose of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also 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-cancer effects). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect
Timeline
- Start
- 2012-01
- Primary completion
- 2016-09
- Completion
- 2016-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | therapeutic allogeneic lymphocytes | Cell therapy | 1 cells/kg | — |
| Subject | therapeutic allogeneic lymphocytes | Cell therapy | 5 cells/kg | — |
| Subject | therapeutic allogeneic lymphocytes | Cell therapy | 10 cells/kg | — |
Indications
Burkitt lymphoma
Hodgkins lymphoma
MALT lymphoma
Waldenstrom macroglobulinemia
acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22)
acute myeloid leukemia with t(8;21)(q22;q22) translocation
acute myeloid leukemia, t(15;17)(q24;q21)
acute myeloid leukemia, t(16;16)(p13.1;q22)
adult T-cell leukemia/lymphoma
adult acute lymphoblastic leukemia
chronic lymphocytic leukemia/small lymphocytic lymphoma
chronic myeloid leukemia
extranodal nasal NK/T cell lymphoma
grade III lymphomatoid granulomatosis
hepatosplenic T-cell lymphoma
intraocular lymphoma
large-cell immunoblastic lymphoma
mantle cell lymphoma
mycosis fungoides and variants
nodal marginal zone B-cell lymphoma
peripheral T-cell lymphoma, not otherwise specified
primary cutaneous B-cell lymphoma
splenic marginal zone lymphoma