Background:
Stem cell or bone marrow transplants can cure or control blood cancers. Sometimes the donor
cells see the recipient's body as foreign. This can cause complications. A high dose of the
drug cyclophosphamide (PTCy) can help reduce these risks. Researchers want to see if a lower
dose of PTCy can have the same benefits. Based on encouraging results from the first part of
the study, researchers now are investigating whether a lower dose of PTCy can allow other
immunosuppression to be decreased.
Objective:
To see if a lower dose of PTCy and now also shorter duration of another immunosuppressant
called mycophenolate mofetil will help people with blood cancers have a more successful
transplant and fewer side effects.
Eligibility:
People ages 15-65 with leukemia, lymphoma, or multiple myeloma that is not curable with
standard therapy and is at high risk of returning without transplant, and their healthy adult
relatives
Design:
Transplant participants will be screened with:
Blood, urine, breathing, and heart tests
Scans
Chest x-ray
Bone marrow samples: A needle inserted into the participant s pelvis will remove marrow and a
bone fragment.
Transplant recipients will stay at the hospital and be prepped with chemotherapy over 6 days
for the transplant. They will get stem cells through a catheter in the chest or neck. They
will get the cyclophosphamide chemotherapy. They will stay in the hospital about 4 more
weeks. They will have blood transfusions. They will have frequent blood tests and 2 bone
marrow samples within 1 year after the transplant.
Donor participants will be screened with:
Blood, urine, and heart tests
Chest x-ray
Scans
Donor participants will have bone marrow taken from their pelvis or stem cells taken from
their blood. For the blood donation, blood will be taken from a vein in one arm, move through
a machine to remove white blood cells, and be returned through a vein in the other arm.
Participation will last up to 5 years....
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Cancer Institute (NCI)
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)