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Clinical Trial Summary

To see if it is possible to use short-duration tacrolimus after a peripheral blood stem cell transplant in certain malignancies that are considered difficult to engraft.


Clinical Trial Description

The main goal is to learn whether a drug called tacrolimus, which is an immune-lowering drug (an immunosuppressant) given after transplant to help prevent certain complications, can be given safely for a shorter period of time than it has been in the past. The experiences with immunosuppression duration with other allogeneic HSCT platforms cannot be directly extrapolated to the high-dose posttransplantation cyclophosphamide platform (another type of immunosuppressant given after transplant to help prevent GVHD). There are presently no published data on the minimum required duration of tacrolimus after nonmyeloablative HSCT that includes high-dose Cy as part of postgrafting immunosuppression. The effectiveness of high-dose posttransplantation Cy in GVHD prevention, however, permits the investigation of this question. At the present time there are few or no cures for diseases studied on this trial outside of a bone marrow or peripheral blood transplant. The peripheral blood for this transplant comes from a relative who is a half-match or "haplo" match to the participant. Possible donors include parents, siblings, and children. In order to help the bone marrow grow, or "take", inside the body, participants will receive chemotherapy and radiation before the transplant. After the transplant participants will receive high doses of cyclophosphamide (Cytoxan®) along with other medications to lower the immune system, such as tacrolimus. These medications may lower the risk of graft versus host disease (GVHD) and of rejection of the peripheral blood graft. ;


Study Design


Related Conditions & MeSH terms

  • Chronic Lymphocytic Leukemia
  • Chronic Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Chronic Myeloproliferative Disorders
  • Essential Thrombocythemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myelomonocytic, Juvenile
  • Leukemia, Plasma Cell
  • Leukemia, Prolymphocytic
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • Myelofibrosis
  • Myeloproliferative Disorders
  • Neoplasms, Plasma Cell
  • Paraproteinemias
  • Plasma Cell Dyscrasia
  • Plasma Cell Leukemia
  • Plasma Cell Neoplasm
  • Plasmacytoma
  • Polycythemia
  • Polycythemia Vera
  • Prolymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Thrombocythemia, Essential
  • Thrombocytosis

NCT number NCT02556931
Study type Interventional
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact
Status Completed
Phase Phase 2
Start date December 2015
Completion date April 2021

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