Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma

  • End date
    Apr 30, 2028
  • participants needed
  • sponsor
    National Cancer Institute (NCI)
Updated on 22 July 2022
estimated creatinine clearance
oxygen saturation
urine tests
stem cell transplantation
graft versus host disease
hematologic malignancy
ejection fraction
granulocyte colony stimulating factor
cell transplantation
bone marrow procedure
colony stimulating factor
blood transfusion
chemotherapy regimen
pulmonary function tests
therapeutic agents
t-cell lymphoma
anaplastic large cell lymphoma
hla typing
hemophagocytic lymphohistiocytosis
Accepts healthy volunteers



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.


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.


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


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:


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.



Mature neoplasms of T and/or natural killer cells, collectively called peripheral T-cell lymphomas (PTCL), are often poorly responsive to chemotherapy and therefore associated with significant morbidity and mortality.

Allogeneic hematopoietic cell transplantation (HCT) has the potential to cure PTCL but the optimal approach to HCT for these diseases requires ongoing investigation


For subjects on the reduced-intensity conditioning (RIC/mRIC) arms, to estimate the progression-free survival

For subjects on the immunosuppression-only conditioning (IOC) and ATL/RIC arms, because they are high risk patients, to preliminarily estimate the proportion who are progression free at one year.


Patients age >= 12 years

PTCL that is relapsed or refractory to prior therapy and/or PTCL of a risk score 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 potentially suitable 7-8/8 HLA-matched related or unrelated donor (at HLA A, B, C, and DR), or an HLA-haploidentical related donor

Adequate end-organ function

Not pregnant or breastfeeding


There will be four recipient treatment arms that vary in approach, although all with the same backbone of conditioning and GVHD prophylaxis:

Immunosuppression-only conditioning (IOC) arm for high-risk subjects

Reduced-intensity conditioning (RIC) arm for those deemed not high-risk and able to tolerate RIC and without adult T cell leukemia/lymphoma (ATL)

mRIC arm for patients eligible for the RIC arm, as a modified expansion upon completion of the RIC arm

ATL-RIC arm for patients with a diagnosis of ATL

IOC arm: equine anti-thymocyte globulin (e-ATG) 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m^2/day IV on days -9 and -5, low-dose cyclophosphamide (5 mg/kg) orally daily on days -9 through -2

Subjects will be assigned to the IOC arm if there is significant end-organ dysfunction present and it is felt that a conditioning regimen that includes busulfan would likely be associated with intolerable or life-threatening toxicities for the patient. Patients will also be assigned to the IOC arm if they possess a DNA repair defect, telomere maintenance defect, or familial cancer predisposition syndrome that necessitates limiting chemotherapy as much as possible to prevent future cancer risk.

RIC arm: e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m^2/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.

mRIC arm: e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m^2/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, G-CSF 5 mcg/kg/day subcutaneous on days -12, -8, and -4.

ATL-RIC arm: e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m^2/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, G-CSF 5 mcg/kg/day subcutaneous on days -12, -8, and -4, ruxolitinib 45 mg/day from day -12 through day -2, and zidovudine 300 mg orally three times a day from day -1 through day +50.

Peripheral blood stem cells are the preferred graft source, although bone marrow is permitted

GVHD prophylaxis: Post-transplantation cyclophosphamide (PTCy) on days +3 and +4 (50 mg/kg/day on RIC arm, mRIC, and ATL-RIC arms and 25 mg/kg/day on the IOC arm, with the option of 25 mg/kg/day on the RIC arm). Sirolimus on days +5 through +60 (RIC arm, mRIC arm, IOC arm). Patients with somatic mutations in the Akt/mTOR pathway may receive tacrolimus days +5 through +60 instead of sirolimus on the RIC, mRIC, or IOC arms. Mycophenolate mofetil (MMF) on days +5 through +25 on the RIC, IOC, and mRIC arms; MMF will not be given on the ATL-RIC arm. Patients on the ATL-RIC arm will receive tacrolimus on days +5 through +50 and ruxolitinib 15 mg/day from days +5 through +35, 10 mg/day from days +36 through +60, and 5 mg/day from days +61 through +70.

Condition Peripheral T-cell Lymphomas, Lymphoproliferative Disorders, Immune System Diseases
Treatment GVHD Prophylaxis, IOC, RIC, allo HCT, mRIC, ATL-RIC
Clinical Study IdentifierNCT03922724
SponsorNational Cancer Institute (NCI)
Last Modified on22 July 2022


Yes No Not Sure

Inclusion Criteria

Unrelated donors will be evaluated in accordance with existing NMDP Standard Policies and
Procedures, available at: <>
Standards/, except for the additional requirement of EBV serostatus testing for clinical
purposes of donor selection. Note that participation in this study is offered to all
unrelated donors but not required for clinical donation, so it is possible that not all
unrelated donors will enroll on this study. Unrelated donors only enroll if they contribute
research specimens, which is optional

Exclusion Criteria

Unrelated donors: failure to qualify as a National Marrow Donor Program (NMDP) donor per
current NMDP Standards, available at: <>-
network/Standards/. Exceptions to donor eligibility (e.g. foreign travel, tattoos) do not
automatically exclude the donor and will be reviewed by the PI
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