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 range18 Years

SexALL

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)
✓. 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

What they're measuring

Rate of regimen-related toxicities

Timeframe: Up to 100 days post-transplant

Rate for hematopoietic engraftment

Timeframe: Up to 100 days post-transplant

Rate for immune reconstitution

Timeframe: Up to 100 days post-transplant

Incidence of GVHD

Timeframe: Up to 100 days post-transplant

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-23

View on ClinicalTrials.gov More Cutaneous T-Cell Non-Hodgkin Lymphoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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)
✓. 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

What they're measuring

Rate of regimen-related toxicities

Timeframe: Up to 100 days post-transplant

Rate for hematopoietic engraftment

Timeframe: Up to 100 days post-transplant

Rate for immune reconstitution

Timeframe: Up to 100 days post-transplant

Incidence of GVHD

Timeframe: Up to 100 days post-transplant

Maximum tolerated dose of DLI, determined according to dose limiting toxicities

Timeframe: day -4