Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-120
SponsorNational Cancer Institute (NCI)
About this trial
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.
Eligibility criteria
Qualifiers
Age >=12 years
Diagnosis of PTCL, confirmed by NCI pathology review, that is relapsed or refractory to prior therapy, and/or PTCL where upfront allo HCT in first remission is reasonable (PIT score of intermediate-low risk or higher or supported by clinical practice guidelines)
At least one potential 7-8/8 HLA-matched related (excluding an identical twin) or unrelated donor (at HLA-A, -B, -C, and DR), or an HLA-haploidentical related donor, based on initial low resolution unrelated donor search and/or at least one biologically-related family member who has at least a 25% chance of being at minimum an HLAhaploidentical match and is potentially suitable to donate based on reported family history. HLA typing of potential donors and/or mutation testing does not need to be completed for eligibility.
For RIC: Left ventricular ejection fraction (LVEF) >= 40% by 2D echocardiogram (ECHO) or MUGA, left ventricular shortening fraction >= 20% by ECHO, or LVEF >= 30% if the patient has radiologic evidence of aortic, renal, or coronary artery vasculitis. For IOC: LVEF >= 30% by 2D ECHO or MUGA.
Disqualifiers
Patients who are receiving any other investigational agents, with the exception of virus-specific cytotoxic T-cells for the treatment of viral infection/reactivation prior to allo HCT.
Prohibitive allergy to a study drug or to compounds of similar chemical or biologic composition of the agents (e-ATG, steroids, cyclophosphamide, busulfan, pentostatin, sirolimus, MMF, filgrastim or biosimilar drug) used in the study
Lack of central venous access potential
Active psychiatric disorder which is deemed by the PI to have significant risk of compromising compliance with the transplant protocol or which does not allow for appropriate informed consent
Trial design
Treatments tested in this trial
- ATL-RIC
- mRIC
- allo HCT
- RIC
- GVHD prophylaxis
- IOC
Treatment groups
330 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov