Shortened-duration tacrolimus following nonmyeloablative, related donor BMT with high-dose posttransplantation cyclophosphamide
This research is being done to find out how to increase the effectiveness of a *mini* Bone Marrow Transplant (BMT), from a relative who is not a perfect tissue match. Mini-transplants rely on drugs that suppress the immune system to allow the donors marrow to grow, or engraft, inside your body, however these drugs often carry risk of negative side effects. The main goal of this study is to learn whether tacrolimus, one of these immunosuppressant drugs, can be given safely for a shorter period of time than it has been in the past. To minimize graft rejection tacrolimus is usually given for 6 months after transplant. The study will look at the possibility of giving tacrolimus for shorter durations (2months, 3months and 4 months) after transplant while studying the benefits and the side effects of this course of treatment in hopes to better understand how well mini-transplants work when done this way.
- Patients age 0.5 to 75 yrs old who have never had a donor related BMT in the past. - Good physical condition with good lung, heart, and kidney functions - Donor must be first degree related (sibling, offspring), approved to donate and willing to participate. **NOTE: Relatives that have donated blood for tranfusions to the patient in the past will not be considered eligible donors. - Eligible diagnoses: Patient must be in remission and/or stable condition with one of the following -- ï¿½ Hodgkins, non-Hodgkins or poor-risk Lymphoma that meets specific parameters ï¿½ AML, ALL or poor risk acute leukemia that meets specific parameters ï¿½ High Grade MDS with poor risk features ï¿½ Refractory CML or CML in second or higher chronic phase ï¿½ chronic or juvenile MML ï¿½ Philadelphia chromosome negative myeloproliferative disease
If you are found to be eligible, and you choose to join this study, a large intravenous catheter will be surgically placed to help with the administration of the medications (chemotherapy agents, antibiotics, blood transfusions) as well as obtaining blood samples. You will be given five days of chemotherapy (fludarabine) through the catheter and one day of radiation. You will also receive 2 days of cyclophosphamide through the catheter on the first 2 days for fludarabine. On the day after radiation, the bone marrow will be taken from your donor and given to you like a blood transfusion. Two more doses of cyclophosphamide will be given, one on the 3rd day after the marrow infusion and one on the 4th day after. On the 5th day after transplant you will begin tacrolimus, initially given through the catheter but will switch to pills taken by mouth once you are tolerating food and drink well. You will be assigned a specific duration (60, 90 or 120 days)of tacrolimus as determined by the study protocol. Other medications will be given after the marrow infusion (by vein and by mouth) to help prevent side effects of the BMT (such as infections, and to help your body from rejecting the donors marrow). During the follow up time, many blood samples and physician exams will be done. Some of the blood samples you give will be for research purposes. Your progress and the results from your follow up visits and physician assessments will determine if your scheduled duration of tacrolimus will remain the same or be changed. Most of the time, the chemotherapy, radiation, marrow infusion, and follow up period are done on an outpatient basis. It is required that you and a caregiver stay near Johns Hopkins Hospital throughout the whole process which is about 2-3 months. You will be discharged back to your local oncologist after the 60 day post transplant evaluation. ***It is important to understand that you will be required to return to JHH for evaluation at specific times post transplant ï¿½ 84 days, ï¿½ 112 days, ï¿½ 6 months, ï¿½ 9 months and ï¿½ 1 year after the transplant. This commitment is a requirement for this protocol. Additional long term follow up at Hopkins may take place yearly for 5 years per standard BMT procedures.
12/09/2013 04:02 AM