Shorter Course Tacrolimus After Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide
|ClinicalTrials.gov Identifier: NCT01342289|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2011
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin's Lymphoma Leukemia Myelodysplastic Syndrome(MDS) Multiple Myeloma Non Hodgkin's Lymphoma||Procedure: Bone Marrow Transplant||Phase 1 Phase 2|
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.
At the present time there are few or no cures for your type of disease outside of a bone marrow transplant. The bone marrow for this transplant comes from a relative who is a half-match or "haplo" match to you. Possible donors include parents, siblings, and children. In order to help the bone marrow grow, or "take", inside your body, you will receive chemotherapy and radiation before the transplant. After the transplant you will receive high doses of cyclophosphamide (Cytoxan®) along with other medications to lower the immune system, tacrolimus. These medications may lower the risk of graft versus host disease (GVHD) and of your body rejecting the bone marrow graft.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Shortened-duration Tacrolimus Following Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2022|
Procedure: Bone Marrow Transplant
- High-dose Cy
- Evaluate the safety of reduced-duration tacrolimus (from Day 5 through either To estimate the number of patients with GVHD as a measure of the safety of reduced-duration tacrolimus [ Time Frame: Day 5 - Day 120 ]Immunosuppression must be sufficient to prevent excessive rates of GVHD including severe GVHD. There are presently no published data on the minimum required duration of tacrolimus after nonmyeloablative, partially HLA-mismatched BMT that includes high-dose Cy as part of postgrafting immunosuppression.
- To estimate the tolerability of reduced-duration tacrolimus on patients following nonmyeloablative transplant. [ Time Frame: Day 60 - Day 180 ]Tacrolimus levels will be monitored. Patients who develop a prohibitive toxicity to tacrolimus (resulting in earlier than scheduled discontinuation of tacrolimus) will be considered unevaluable for the primary endpoint. The duration of tacrolimus will be evaluated at Day 90. If tacrolimus at Day 90 appears feasible, then it will be continued until Day 120 with analogous monitoring rules.
- Incidence of GVHD [ Time Frame: Day 180, and beyond Day 180 (up to 7 years) ]Estimate the incidences of acute grade II-IV GVHD, acute grade III or higher GVHD, chronic GVHD, graft failure, relapse, and nonrelapse mortality between the date of early tacrolimus cessation and Day 180, and beyond Day 180.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342289
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Richard Jones, M.D.||Johns Hopkins University|