Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03922724
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Immune System Diseases
  • Lymphoproliferative Disorders
  • Peripheral T-cell Lymphomas

Eligibility Criteria

Sex
ALL
Age
12 Years - 120 Years
Healthy Volunteers
Accepted

Interventions

  • ATL-RIC — DRUG
    e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m2/day IV on days -11 and -7, low-dose cyclophosphamide (5 mg/kg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, filgrastim or biosimilar drug 5mcg /kg/day subcutaneous on days -12, -8, and -4, ruxolitinib 45 mg/day from day -12 through day -2, and zidovudine 300mg orally three times a day from day -1 through day +50.
  • mRIC — DRUG
    e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m2/day IV on days -11 and -7, lowdose cyclophosphamide (5 mg/kg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, filgrastim or biosimilar drug 5 mcg/kg/day subcutaneous on days -12, -8, and -4.
  • allo HCT — PROCEDURE
    Stem cell transplant
  • RIC — DRUG
    e-ATG 40 mg/kg/day IV on days -14 and -13. Pentostatin 4mg /m2/day IV on days -11 and -7. Cyclophosphamide 5 mg/kg orally daily on days -11 through -4. Busulfan IV, pharmacokinetically dosed, on days -3 and -2.
  • GVHD prophylaxis — DRUG
    High-dose, post-transplantation cyclophosphamide (PTCy) on days +3 and +4 ( 25 mg/kg/day on both arms), sirolimus on days +5 through +60, and mycophenolate mofetil (MMF) on days +5 through +25.
  • IOC — DRUG
    e-ATG40 mg/kg/day IV on days -14 and -13. Pentostatin 4 mg/m2/day IV on days -9 and -5. Cyclophosphamide 5 mg/kg orally daily on days -9 through -2

Study Details

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.

Key Dates

Start date
Apr 18, 2019
Status verified
Jun 2026
Primary completion
Jun 1, 2027
Completion
Oct 31, 2030

Study Design

Enrollment
330 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1/RIC Arm
    Reduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis
  • Experimental: 2/IOC Arm
    Immunosuppression Only Conditioning, plus allogeneic HCT with GVHD prophylaxis
  • No Intervention: 3/Donor Arm
    Donors for Recipients in Arm 1, Arm 2, Arm 4, or Arm 5
  • Experimental: 4/mRIC Arm
    modified Reduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis
  • Experimental: 5/ATL-RIC Arm
    modified Reduced Intensity Conditioning Arm for ATL patients, plus allogeneic HCT with GVHD prophylaxis

Primary Outcome Measure

Progression-free survival (PFS) of HCT recipients on the RIC arm and the mRIC arm [ Time Frame: 1 year post transplant ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937
National Marrow Donor ProgramMinneapolisMinnesota55401-

Find similar trials in Bethesda, MD

By research site
National Institutes of Health Clinical Center· Bethesda, MDNational Marrow Donor Program· Minneapolis, MN

Related Studies