Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
Summary
Background: Lymphoma is a type of blood cancer. Blood cell transplant can cure some people with lymphoma. Researchers want to see if they can limit the complications transplant can cause. Objective: To test if a stem cell transplant can cure or control lymphoma. Also to test if new ways of getting a recipient ready for a transplant may result in fewer problems and side effects. Eligibility: Recipients: People ages 12 and older with peripheral T cell lymphoma that does not respond to standard treatments Donors: Healthy people ages 18 and older whose relative has lymphoma Design: Participants will be screened with: Physical exam Blood and urine tests Bone marrow biopsy: A needle inserted into the participant s hip bone will remove marrow. Donors will also be screened with: X-rays Recipients will also be screened with: Lying in scanners that take pictures of the body Tumor sample Donors may donate blood. They will take daily shots for 5 7 days. They will have apheresis: A machine will take blood from one arm and take out their stem cells. The blood will be returned into the other arm. Recipients will be hospitalized at least 2 weeks before transplant. They will get a catheter: A plastic tube will be inserted into a vein in the neck or upper chest. They will get antibody therapy or chemotherapy. Recipients will get the transplant through their catheter. Recipients will stay in the hospital several weeks after transplant. They will get blood transfusions. They will take drugs including chemotherapy for about 2 months. Recipients will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years. ...
Timeline
- Start
- 2019-04-18
- Primary completion
- 2027-06-01
- Completion
- 2030-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | — | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 5 mg/kg | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 25 mg/kg | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 50 mg/kg | Oral |
| Subject | Mycophenolate Mofetil | Small molecule | — | — |
| Subject | Pentostatin | Small molecule | 4 mg/m2 | Intravenous |
| Subject | Ruxolitinib | Small molecule | 15 mg | — |
| Subject | Sirolimus | Small molecule | — | — |
| Subject | Tacrolimus | Small molecule | — | — |
| Subject | Zidovudine | Small molecule | 300 mg | Oral |
| Subject | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 40 mg/kg | Intravenous |