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Protocol Details

Phase II Trial of Allogeneic Hematopoietic Cell Transplantation for Peripheral T cell Lymphoma

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 12 Years
Max Age: 120 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women


Immune Dysregulation;
Opportunistic Infection

Recruitment Keyword(s)



peripheral T-cell lymphomas;
Lymphoproliferative Disorders;
Immune System Diseases

Investigational Drug(s)


Investigational Device(s)



Drug: mRIC
Procedure/Surgery: allo HCT
Drug: RIC
Drug: GVHD prophylaxis
Drug: IOC

Supporting Site

National Cancer Institute


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.

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1 Age greater than or equal to 12 years

2 Diagnosis of PTCL, confirmed by NCI pathology review, that is relapsed or refractory to prior therapy, and/or PTCL where upfront allo HCT in first remission is reasonable (PIT score of intermediate-low risk or higher or supported by clinical practice guidelines1)

--ALK-positive ALCL patients will only be eligible if relapsed or refractory

3 At least one potential 7-8/8 HLA-matched related (excluding an identical twin) or unrelated donor (at HLA-A, -B, -C, and DR), or an HLA-haploidentical related donor, based on initial low resolution unrelated donor search and/or at least one iologicallyrelated family member who has at least a 25% chance of being at minimum an HLAhaploidentical match and is potentially suitable to donate based on reported family history. HLA typing of potential donors and/or mutation testing does not need to be completed for eligibility.

4 Adequate end-organ function, as measured by:

--For RIC: Left ventricular ejection fraction (LVEF) greater than or equal to 40% by 2D echocardiogram (ECHO) or MUGA, left ventricular shortening fraction greater than or equal to 20% by ECHO, or LVEF greater than or equal to 30% if the patient has radiologic evidence of aortic, renal, or coronary artery vasculitis. For IOC: LVEF greater than or equal to 30% by 2D ECHO or MUGA.

--Pulmonary function tests: DLco (corrected for hemoglobin) and FEV1 greater than or equal to 40% of predicted for the RIC arm, and greater than or equal to 30% predicted for the IOC arm; or in pediatric patients, if unable to perform pulmonary function tests, there should be no evidence of dyspnea at rest, no requirement for supplemental oxygen, and oxygen saturation >92% on room air. Calculations will be based on the USA-ITS-NIH reference.

--Bilirubin less than or equal to 3.0 mg/dL (unless due to Gilbert s syndrome or hemolysis) for patients receiving RIC and bilirubin less than or equal to 5.0 mg/dL for patients receiving IOC (unless due to Gilbert s syndrome or hemolysis); ALT and AST less than or equal to 10 x ULN for patients receiving RIC or IOC. Patients who are above these bilirubin, ALT, or AST thresholds may be eligible for the RIC or IOC arm if evaluated by a hepatologist who deems the liver function test abnormalities to be potentially disease related, either because of direct involvement by PTCL, due to an associated process such as hemophagocytic lymphohistiocytosis, or as sequelae of prior chemotherapy that is thought to improve with time.

--Estimated creatinine clearance of greater than or equal to 50 mL/min/1.73 m2, calculated using eGFR in the clinical lab for adults and the Schwartz formula for pediatrics.

5 Karnofsky (adults) or Lansky (children) performance status of greater than or equal to 50% or ECOG performance status of 2 or less for the RIC arm and Karnofsky (adults) or Lansky (children) greater than or equal to 30% or ECOG performance status of 3 or less for the IOC arm

6 Ability of subject or parent/guardian to understand and the willingness to sign a written informed consent document

7 Not pregnant or breastfeeding.

8 As therapeutic agents used in this trial may be harmful to a fetus, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one year post-allo HCT. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in the study, she should inform her treating physician immediately.


1 Patients who are receiving any other investigational agents, with the exception of virus specific cytotoxic T-cells for the treatment of viral infection/reactivation prior to allo HCT.

2 Prohibitive allergy to a study drug or to compounds of similar chemical or biologic composition of the agents (e-ATG, steroids, cyclophosphamide, busulfan, pentostatin, sirolimus, MMF, filgrastim or biosimilar drug) used in the study

3 Lack of central venous access potential

4 Active psychiatric disorder which is deemed by the PI to have significant risk of compromising compliance with the transplant protocol or which does not allow for appropriate informed consent


1 Related donor deemed suitable and eligible, and willing to donate, per clinical evaluations who are additionally willing to donate blood and/or marrow/peripheral blood stem cells for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.




1 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


1 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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Not Provided

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Principal Investigator

Referral Contact

For more information:

Jennifer A. Kanakry, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3132
(240) 858-9255

Jessenia C. Campos, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4-3152
10 Center Drive
Bethesda, Maryland 20892
(240) 858-7492

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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