At a glance
ClinicalIndex Comparison Record- ✓Age ≥12 years
- ✓Diagnosis of PTCL confirmed by NCI pathology review, relapsed/refractory to prior therapy or upfront allo HCT reasonable (PIT score intermediate-low risk or higher)
- ✓ALK-positive ALCL only eligible if relapsed or refractory
- ✓At least one HLA-matched related donor (excluding identical twin), unrelated donor (7-8/8 HLA match), or haploidentical related donor based on initial search or biologically-related family member with ≥25% chance of haploidentical match
- ✕Receiving other investigational agents (except virus-specific cytotoxic T-cells for viral infection/reactivation prior to allo HCT)
- ✕Prohibitive allergy to study drugs (e-ATG, steroids, cyclophosphamide, busulfan, pentostatin, sirolimus, MMF, filgrastim or biosimilar)
- ✕Lack of central venous access potential
- ✕Active psychiatric disorder with significant risk of compromising compliance or preventing appropriate informed consent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating ATL-RIC, mRIC, and 4 other interventions for Peripheral T-cell Lymphomas and 2 related conditions. Currently recruiting, targeting 330 participants across 2 sites.
Signals
Detailed 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. ...
Study Details
Timeline
Arms & Interventions
Reduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis
Immunosuppression Only Conditioning, plus allogeneic HCT with GVHD prophylaxis
Donors for Recipients in Arm 1, Arm 2, Arm 4, or Arm 5
modified Reduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis
modified Reduced Intensity Conditioning Arm for ATL patients, plus allogeneic HCT with GVHD prophylaxis
Interventions
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.
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.
Stem cell transplant
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.
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.
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