Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
This study is investigating different ways to prepare patients for an allogeneic hematopoietic cell transplant (allo HCT), also known as a stem cell transplant, for Peripheral T-cell Lymphoma (PTCL). Researchers are comparing several conditioning regimens (treatments given before transplant to prepare your body): ATL-RIC, mRIC, and RIC. These regimens involve drugs like e-ATG, pentostatin, cyclophosphamide, and busulfan. After the transplant, you will receive GVHD prophylaxis (treatment to prevent graft-versus-host disease) with high-dose cyclophosphamide, sirolimus, and mycophenolate mofetil (MMF). The study is looking for people aged 12 and older with PTCL that has returned or not responded to previous treatments. The main goal is to see how many participants are free from cancer progression one year after their transplant.
- Study design
- This interventional study plans to enroll 330 participants. There are four different treatment arms, all using the same core conditioning and GVHD prophylaxis.
- What's involved
- You will undergo screening tests including a physical exam, blood and urine tests, and a bone marrow biopsy. The study involves receiving specific drug regimens before and after your stem cell transplant.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be measured at one year after your transplant.
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NCT03922724
Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
Active, Not Recruiting
PHASE2Ages 12+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~91 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:ATL-RICmRICallo HCTRICGVHD prophylaxisIOC
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) of HCT recipients on the RIC arm and the mRIC arm
Measured over 1 year post transplant
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesMaryland1
Minnesota1
Study leadership
- Dimana Dimitrova, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age \>=12 years
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 guidelines)
ALK-positive ALCL patients will only be eligible if relapsed or refractory
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 biologically-related 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.
Adequate end-organ function, as measured by:
For RIC: Left ventricular ejection fraction (LVEF) \>= 40% by 2D echocardiogram (ECHO) or MUGA, left ventricular shortening fraction \>= 20% by ECHO, or LVEF \>= 30% if the patient has radiologic evidence of aortic, renal, or coronary artery vasculitis. For IOC: LVEF \>= 30% by 2D ECHO or MUGA.
Pulmonary function tests: DLco (corrected for hemoglobin) and FEV1 \>= 40% of predicted for the RIC arm, and \>= 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.
Bilirubin \<= 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis) for patients receiving RIC and bilirubin \<= 5.0 mg/dL for patients receiving IOC (unless due to Gilbert s syndrome or hemolysis); ALT and AST \<= 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 \>= 50 mL/min/1.73 m\^2, calculated using eGFR in the clinical lab for adults and the Schwartz formula for pediatrics.
Karnofsky (adults) or Lansky (children) performance status of \>= 50% or ECOG performance status of 2 or less for the RIC arm and Karnofsky (adults) or Lansky (children) \>= 30% or ECOG performance status of 3 or less for the IOC arm
Ability of subject or parent/guardian to understand and the willingness to sign a written informed consent document
Not pregnant or breastfeeding.
As therapeutic agents used in this trial may be harmful to a fetus, individuals of childbearing potential and individuals who can father children 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.
Related donor deemed suitable and eligible, and willing to donate, per clinical evaluations who are additionally willing to donate blood and/or 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.
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
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.
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
Lack of central venous access potential
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
Unrelated donors: failure to qualify as a National Marrow Donor Program (NMDP) donor per current NMDP Standards, available at: http://bethematch.org/About-Us/Globaltransplant- network/Standards/. Exceptions to donor eligibility (e.g. foreign travel, tattoos) do not automatically exclude the donor and will be reviewed by the PI.
What this trial measures
- Progression-free survival (PFS) of HCT recipients on the RIC arm and the mRIC arm1 year post transplant
Number of patients who are alive and with PFS at one year, assessed by Kaplan-Meier with 80% and 95% two-sided confidence intervals
- Progression-free survival (PFS) of HCT recipients on the IOC arm and ATL-RIC arm1 year post transplant
Number of patients who are alive and with PFS at one year, assessed by Kaplan-Meier with 80% and 95% two-sided confidence intervals