Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Apr 30, 2026
  • participants needed
    330
  • sponsor
    National Cancer Institute (NCI)
Updated on 5 May 2021
estimated creatinine clearance
cancer
oxygen saturation
urine tests
stem cell transplantation
graft versus host disease
hematologic malignancy
lymphoma
busulfan
filgrastim
ejection fraction
granulocyte colony stimulating factor
cell transplantation
bone marrow procedure
hemolysis
colony stimulating factor
blood transfusion
chemotherapy regimen
pulmonary function tests
apheresis
therapeutic agents
t-cell lymphoma
anaplastic large cell lymphoma
hla typing
hemophagocytic lymphohistiocytosis

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.

Description

Background
  • 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
    Objectives
  • For subjects on the reduced-intensity conditioning (RIC arm), 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.
    Eligibility
  • Patients age greater than or equal to 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 guidelines1)
  • 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
    Design
  • 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/m2/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/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.
  • mRIC arm: 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, 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/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, 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). , Ssirolimus 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 1mg/day from days +5 through +35, 10 mg/day from days +36 through +60, and 5 mg/day from days +61 through +70.

Details
Condition Disorder of immune system, Peripheral T-Cell Lymphoma, Lymphoproliferative Disorder, Lymphoproliferative disorders, lymphoproliferative disease, immune disorder, immune disorders, immunologic disease, immune dysfunction, immune disease, immun
Treatment GVHD Prophylaxis, IOC, RIC, allo HCT, mRIC, ATL-RIC
Clinical Study IdentifierNCT03922724
SponsorNational Cancer Institute (NCI)
Last Modified on5 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: immunologic disease or immune disease or immun or immune disorders or Lymphoproliferative Disorder or lymphoproliferative disease or immune dysfunctio...?
Do you have any of these conditions: immune disease or Peripheral T-Cell Lymphoma or Lymphoproliferative disorders or immune disorders or immun or Lymphoproliferative Disorder or lymphopr...?
Do you have any of these conditions: Lymphoproliferative Disorder or immunologic disease or immun or immune disorder or Lymphoproliferative disorders or immune dysfunction or immune disor...?
Do you have any of these conditions: immunologic disease or immun or immune dysfunction or immune disease or immune disorder or Lymphoproliferative Disorder or immune disorders or Disorde...?
Do you have any of these conditions: Disorder of immune system or immunologic disease or immune dysfunction or Lymphoproliferative disorders or immun or Lymphoproliferative Disorder or im...?
Do you have any of these conditions: immun or Lymphoproliferative Disorder or lymphoproliferative disease or immune disease or immune disorder or Peripheral T-Cell Lymphoma or immune diso...?
Do you have any of these conditions: Lymphoproliferative disorders or lymphoproliferative disease or immun or Lymphoproliferative Disorder or Disorder of immune system or immune disorders...?
Do you have any of these conditions: immune disorder or immune disease or Peripheral T-Cell Lymphoma or Lymphoproliferative disorders or Disorder of immune system or immune dysfunction or...?
Do you have any of these conditions: immune dysfunction or immunologic disease or Lymphoproliferative Disorder or immune disorder or immune disease or lymphoproliferative disease or immun...?
Do you have any of these conditions: Peripheral T-Cell Lymphoma or immune disease or immune dysfunction or Lymphoproliferative disorders or immunologic disease or immune disorders or immu...?
Is your age greater than or equal to 12 yrs?
Do you have any of these conditions: immune disorder or immun or Disorder of immune system or immune disorders or Lymphoproliferative Disorder or lymphoproliferative disease or Peripheral...?
Do you have any of these conditions: Peripheral T-Cell Lymphoma or Lymphoproliferative Disorder or Lymphoproliferative disorders or lymphoproliferative disease or immune disorder or immun...?
Do you have any of these conditions: immune disorder or immune disease or Lymphoproliferative disorders or Lymphoproliferative Disorder or immune disorders or Peripheral T-Cell Lymphoma o...?
Do you have any of these conditions: Lymphoproliferative Disorder or Lymphoproliferative disorders or immune dysfunction or immune disease or immunologic disease or immun or Peripheral T-...?
Do you have any of these conditions: immune disease or immun or immune disorder or Lymphoproliferative disorders or immune dysfunction or Disorder of immune system or Lymphoproliferative ...?
Do you have any of these conditions: immune disorder or immun or immune dysfunction or Lymphoproliferative disorders or immune disease or Lymphoproliferative Disorder or immune disorders ...?
Do you have any of these conditions: Lymphoproliferative disorders or Disorder of immune system or immune disorders or immune disorder or Peripheral T-Cell Lymphoma or immune dysfunction ...?
Do you have any of these conditions: Lymphoproliferative disorders or Lymphoproliferative Disorder or Peripheral T-Cell Lymphoma or Disorder of immune system?
Gender: Male or Female
Unrelated donors will be evaluated in accordance with existing NMDP Standard
Policies and Procedures, available at: <http://bethematch.org/About-Us/Global-
transplantnetwork/> 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
<http://bethematch.org/About-Us/Globaltransplantnetwork> /Standards
Exceptions to donor eligibility (e.g. foreign travel, tattoos) do not
automatically exclude the donor and will be reviewed by the PI
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note