This trial is examining the effectiveness of modified stem cell transplants (SCT) donated by patient relatives, which have certain immune cells removed to prevent transplant rejection in patients with leukemia and lymphoma. The main outcome will be the maximum dose of SCT that can be given safely and is effective. This study is recruiting in Memphis, TN, US.
The details
Treatment for many different blood cell cancers, such as non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), leukemia, involves SCT. This is a procedure where healthy white blood cells are removed from a patient or someone who is genetically similar, such as a family member. These cells are given back to the patient after chemotherapy to replace the cells killed by the treatment. SCT can be effective at helping to kill cancer cells.
Sometimes patients who receive SCT experience complications. One complication is graft vs host disease (GVHD). This is where the transplanted cells begin attacking the patient. This often happens when the SCT donation comes from a relative and not the patient themselves. A new modification to SCT removes the T cells (a type of inflammatory cells) that are responsible for GVHD.
This trial aims to examine if this modified SCT improves the effectiveness and safety of the treatment for patients with lymphoma or leukemia. The main outcomes measured will be the maximum dose of SCT that can be given safely and is effective and one-year survival without complications from the disease.
Who are they looking for?
This trial is recruiting 140 patients with blood cancer including HL. Patients should have a family member who meets the genetic criteria of the study. Patients should have good kidney, heart, and liver function.
Patients should not have received SCT in the last year. Patients with cancer in the brain or spinal cord cannot participate. Patients with active infections cannot participate. Female patients should not be pregnant or breastfeeding.
The relative of the patient (the donor) should be over 18. Donors should meet the genetic criteria of the study. Donors should be HIV-negative. Female donors should not be pregnant or breastfeeding.
How will it work
All patients will be given the same treatment. Patients will first receive chemotherapy drugs cyclophosphamide (Cytoxan), fludarabine (Fludara), thiotepa (Thioplex), melphalan (Alkeran), mesna (Mesnex) and ATG (Thymoglobulin) to remove T cells. Patients will then receive modified SCT with T cells removed. Some patients will also receive blinatumomab (Blincyto) depending on their type of cancer.
The maximum safest dose of SCT will be measured for 90 days. Time without cancer growing and GVHD will be measured for 1 year. Treatment-related mortality will be measured for 100 days. Patients receiving blinatumomab will be monitored for 120 for side effects.
