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Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies

Descriptive Information
Brief Title † Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies
Official Title † Phase II Study of Shortened-duration Tacrolimus Following Nonmyeloablative Peripheral Blood Stem Cell Transplant With High-dose Posttransplantation Cyclophosphamide in Malignancies That Are Challenging to Engraft
Brief 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.
Detailed 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 Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Percentage of participants who are able to stop prophylactic tacrolimus (D90 cohort)
Secondary Outcome Measure † Incidence of grades III-IV acute GVHD, Days 90-180 (D90)
Condition † Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia Small Lymphocytic Lymphoma Chronic Lymphocytic Leukemia Prolymphocytic Leukemia Chronic Myeloid Leukemia Chronic Myeloproliferative Disorders Multiple Myeloma Plasma Cell Neoplasm Plasma Cell Dyscrasia Myelofibrosis Polycythemia Vera Essential Thrombocythemia Plasma Cell Leukemia
Intervention † DrugFludarabine
Study Arms / Comparison Groups PBSCT D90 Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 90 or Day 180 depending on GVHD status. PBSCT D60 Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 120
Start Date † December 2015
Completion Date December 2019
Primary Completion Date March 2019
Eligibility Criteria † Inclusion Criteria: - Presence of a suitable related HLA-haploidentical or -matched stem cell donor, or a 10/10 matched unrelated donor - Eligible diagnoses: myelodysplastic syndrome (MDS) with at least 1 poor-risk feature; small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) with 17p deletion or with progression 3 months ago - Left ventricular ejection fraction (LVEF) >= 35%, or shortening fraction > 25% - Bilirubin = 40% of predicted; if unable to perform pulmonary function testing, oxygen saturation > 92% on room air - ECOG performance status = 60 Exclusion Criteria: - Pregnancy or active breastfeeding - Uncontrolled active infection - Previous allogeneic transplant - Active extramedullary leukemia or active central nervous system (CNS) malignant disease
Gender All
Ages N/A - N/A
Accepts Healthy Volunteers No
Contacts †† Amy E DeZern, MD, 410-502-7208, adezern1@jhmi.edu
Location Countries † United States
Administrative Information
NCT ID † NCT02556931
Organization ID J15165
Secondary IDs †† IRB00080399
Responsible Party Sponsor
Study Sponsor † Sidney Kimmel Comprehensive Cancer Center
Collaborators ††
Investigators † Principal Investigator: Amy E DeZern, MD, 410-502-7208
Information Provided By
Verification Date April 2017
First Received Date † September 21, 2015
Last Updated Date April 11, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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