Peripheral T-cell LymphomasPhase 2NCT03922724
Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
A Phase 2 study testing ATL-RIC, mRIC and allo HCT in people with Peripheral T-cell Lymphomas and Lymphoproliferative Disorders, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral T-cell Lymphomas, Lymphoproliferative Disorders, Immune System Diseases
- What is being tested?
- ATL-RIC, mRIC and allo HCT
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Apr 2019to 31 Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
- None
- -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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Marrow Donor Program
Minneapolis, Minnesota, 55401
About this study
Official title: Phase II Trial of Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
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.
Read more
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.
Read the detailed 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/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.
Eligibility:
- 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 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, filgrastim or biosimilar drug 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, filgrastim or biosimilar drug 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.
- Being tested
- ATL-RIC, mRIC, allo HCT, RIC, GVHD prophylaxis
- Keywords
- Autoimmunity, Immune Dysregulation, Congenital, Opportunistic Infection
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoproliferative Disorders, Immune System Diseases, Autoimmune Diseases, Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATL-RICDrug
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.
mRICDrug
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.
allo HCTProcedure or surgery
Stem cell transplant
RICDrug
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.
GVHD prophylaxisDrug
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.
IOCDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1/RIC Arm | Experimental | Reduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis Receives: Procedure: allo HCT; Drug: RIC; Drug: GVHD prophylaxis |
| 2/IOC Arm | Experimental | Immunosuppression Only Conditioning, plus allogeneic HCT with GVHD prophylaxis Receives: Procedure: allo HCT; Drug: GVHD prophylaxis; Drug: IOC |
| 3/Donor Arm | No intervention | Donors for Recipients in Arm 1, Arm 2, Arm 4, or Arm 5 |
| 4/mRIC Arm | Experimental | modified Reduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis Receives: Drug: mRIC; Procedure: allo HCT; Drug: GVHD prophylaxis |
| 5/ATL-RIC Arm | Experimental | modified Reduced Intensity Conditioning Arm for ATL patients, plus allogeneic HCT with GVHD prophylaxis Receives: Drug: ATL-RIC; Procedure: allo HCT; Drug: GVHD prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) of HCT recipients on the RIC arm and the mRIC arm
Number of patients who are alive and with PFS at one year, assessed by Kaplan-Meier with 80% and 95% two-sided confidence intervals
Measured: 1 year post transplant
Progression-free survival (PFS) of HCT recipients on the IOC arm and ATL-RIC arm
Number of patients who are alive and with PFS at one year, assessed by Kaplan-Meier with 80% and 95% two-sided confidence intervals
Measured: 1 year post transplant
Secondary outcomes (14)
Incidence of Acute Graft versus-host disease
Cumulative incidence of acute graft versus host disease at 1 year post transplant
Measured: 1 year post transplant
Incidence of Chronic Graft versus-host disease
Cumulative incidence of chronic graft versus host disease at 1 and 2 years post transplant.
Measured: 1 and 2 years post transplant
primary graft failure
Cumulative incidence of secondary graft failure at 60 days post transplant.
Measured: 60 days post transplant
secondary graft failure
Cumulative incidence of secondary graft failure at 1 year post transplant.
Measured: 1 year post transplant
lymphoma relapse
Time from transplant to disease relapse
Measured: 1, 3, and 5 years post transplant
transplant-related mortality
Time from transplant to transplant-related death
Measured: 180 days and 1 year post transplant
kinetics and durability of engraftment
The percentage of donor T-, B-, NK-, and myeloid cell populations
Measured: days +28, +42, +60, +100, +180, and 1 year post transplant
kinetics and durability of lineage-specific donor chimerism
Association between early chimerism data and primary or secondary graft failure
Measured: days +21, +28, +35, +42, and + 60 post transplant
disease-free survival
Time from transplant to death of any cause or disease relapse.
Measured: 1, 3, and 5 years post transplant
event-free survival
Time from transplant to death of any cause or other event, including disease relapse, graft failure
Measured: 1, 3, and 5 years post transplant
overall survival
Time from transplant to death of any cause
Measured: 1, 3, and 5 years post transplant
incidence of EBV, CMV, JCV, BKV, adenovirus, and HHV6
cumulative incidence of EBV, CMV, JCV, BKV, adenovirus, and HHV6 in blood
Measured: day +100 post transplant
GVHD-free graft failure-free survival (GGFS)
Time from transplant to primary or secondary graft failure and death due to grade 3-4 acute GVHD not responsive to seven days of high dose steroids
Measured: 1, 3, and 5 years post transplant
GVHD-free relapse-free survival (GRFS)
Time from transplant to death from any cause of other event
Measured: 1, 3, and 5 years post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start18 Apr 2019
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomasStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Dimana Dimitrova, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922724
- Sponsor's protocol ID
- 190085
- Other IDs
- 19-C-0085
- Status last verified
- 29 Oct 2026
- First submitted
- 19 Apr 2019
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGAP.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03922724
- Acronym / sponsor ID
- 190085
- Keywords
- Autoimmunity, Immune Dysregulation, Congenital, Opportunistic Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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/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.
Eligibility:
- 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 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, filgrastim or biosimilar drug 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, filgrastim or biosimilar drug 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1/RIC Arm | Experimental | Procedure: allo HCT, Drug: RIC, Drug: GVHD prophylaxisReduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis |
| 2/IOC Arm | Experimental | Procedure: allo HCT, Drug: GVHD prophylaxis, Drug: IOCImmunosuppression Only Conditioning, plus allogeneic HCT with GVHD prophylaxis |
| 3/Donor Arm | No intervention | –Donors for Recipients in Arm 1, Arm 2, Arm 4, or Arm 5 |
| 4/mRIC Arm | Experimental | Drug: mRIC, Procedure: allo HCT, Drug: GVHD prophylaxismodified Reduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis |
| 5/ATL-RIC Arm | Experimental | Drug: ATL-RIC, Procedure: allo HCT, Drug: GVHD prophylaxismodified Reduced Intensity Conditioning Arm for ATL patients, plus allogeneic HCT with GVHD prophylaxis |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATL-RICe-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. | Drug | 5/ATL-RIC Arm |
| mRICe-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. | Drug | 4/mRIC Arm |
| allo HCTStem cell transplant | Procedure or surgery | 1/RIC Arm, 2/IOC Arm, 4/mRIC Arm, 5/ATL-RIC Arm |
| RICe-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. | Drug | 1/RIC Arm |
| GVHD prophylaxisHigh-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. | Drug | 1/RIC Arm, 2/IOC Arm, 4/mRIC Arm, 5/ATL-RIC Arm |
| IOCe-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 | Drug | 2/IOC Arm |
Primary outcome
Progression-free survival (PFS) of HCT recipients on the RIC arm and the mRIC arm
Time frame: 1 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 arm
Time frame: 1 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
14 secondary outcomes
Incidence of Acute Graft versus-host disease
Time frame: 1 year post transplant
Incidence of Chronic Graft versus-host disease
Time frame: 1 and 2 years post transplant
primary graft failure
Time frame: 60 days post transplant
secondary graft failure
Time frame: 1 year post transplant
lymphoma relapse
Time frame: 1, 3, and 5 years post transplant
transplant-related mortality
Time frame: 180 days and 1 year post transplant
kinetics and durability of engraftment
Time frame: days +28, +42, +60, +100, +180, and 1 year post transplant
kinetics and durability of lineage-specific donor chimerism
Time frame: days +21, +28, +35, +42, and + 60 post transplant
disease-free survival
Time frame: 1, 3, and 5 years post transplant
event-free survival
Time frame: 1, 3, and 5 years post transplant
overall survival
Time frame: 1, 3, and 5 years post transplant
incidence of EBV, CMV, JCV, BKV, adenovirus, and HHV6
Time frame: day +100 post transplant
GVHD-free graft failure-free survival (GGFS)
Time frame: 1, 3, and 5 years post transplant
GVHD-free relapse-free survival (GRFS)
Time frame: 1, 3, and 5 years post transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGAP.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimana Dimitrova, M.D. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATL-RIC, mRIC and allo HCT in people with Peripheral T-cell Lymphomas and Lymphoproliferative Disorders, run by National Cancer Institute (NCI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) of HCT recipients on the RIC arm and the mRIC arm (time frame: 1 year post transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.