Reduced Intensity Conditioning Before Partially Matched Donor Stem Cell Transplant in Treating Pa… (NCT02548468) | Clinical Trial Compass
WithdrawnPhase 1
Reduced Intensity Conditioning Before Partially Matched Donor Stem Cell Transplant in Treating Patients With Advanced Cutaneous T Cell Lymphoma
Stopped: Slow accrual
0Started 2015-11-20
Plain-language summary
This phase I trial studies the side effects and the best dose of donor lymphocyte infusion when given together with reduced intensity conditioning regimen before partially matched donor stem cell transplant in treating patients with stage IIB-IV mycosis fungoides or Sezary syndrome. Giving chemotherapy and low-dose total-body irradiation followed by high-dose cyclophosphamide before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Removing the T-cells from the donor cells and giving them before transplant may stop this from happening. Additionally, giving tacrolimus and mycophenolate mofetil before and after transplant may also stop this from happening.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Stage IIB-IV mycosis fungoides and sezary syndrome who have failed at least one standard systemic therapy or are not candidates for standard therapy.
. Patient should have a responsive skin disease including complete remission (CR) and partial remission (PR) (close to CR; 75%-99% clearance of skin disease from baseline without new tumors (T3) in patients with T1, T2 or T4 only skin disease) and should not have visceral organ or lymph node involvement prior to transplantation.
. Patients must have a related donor who is a two or more allele mismatch at the HLA-A; B; C; DR and DQ loci. Patients who have sibling donors with a one antigen mismatch due to recombination will not be enrolled in this protocol.
. Patients must have adequate organ function:
. Performance status \> 80% (Karnofsky)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of regimen-related toxicities
Timeframe: Up to 100 days post-transplant
2
Rate for hematopoietic engraftment
Timeframe: Up to 100 days post-transplant
3
Rate for immune reconstitution
Timeframe: Up to 100 days post-transplant
4
Incidence of GVHD
Timeframe: Up to 100 days post-transplant
5
Maximum tolerated dose of DLI, determined according to dose limiting toxicities
Timeframe: day -4
Trial details
NCT IDNCT02548468
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
. Hematopoietic Cell Transplantation Specific Comorbidity Index (HCT-CI) \<5 for age \< 65, HCT-CI \<4 for age \>65
. Patients must be willing to use contraception if they have childbearing potential
. Able to give informed consent, or their legally authorized representative can give informed consent.
Exclusion criteria
. Performance status of \< 80% (Karnofsky)
. HIV positive
. Active involvement of the central nervous system with malignancy
. Psychiatric disorder that would preclude patients from signing an informed consent
. Pregnancy, or unwillingness to use contraception if they are have childbearing potential.
. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder or complications there from.
. Patients who have received alemtuzumab within 8 weeks of transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin (ATG) and have ATG levels of \> 2 μgm/ml.