ClinicalTrials.gg
CompletedNCT01839916Updated Aug 7, 2019Results posted

Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

A Phase 2 interventional study of therapeutic allogeneic lymphocytes and laboratory biomarker analysis in Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q), sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-07.

Primary conditionLymphoma, Extranodal NK-T-CellRegistry: Leukemia, Myeloid, Accelerated PhaseReclassifiedWhy we changed it
Registry
Leukemia, Myeloid, Accelerated Phase — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lymphoma, Extranodal NK-T-Cell
Why
  1. Leukemia, Myeloid, Accelerated Phase is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Lymphoma, Extranodal NK-T-Cell.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Chicago · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
77
Allocation
Not applicable
Ages
14 Years to 75 Years
Sex
All
01

Study summary

This pilot phase II trial studies how well giving donor T cells after donor stem cell transplant works in treating patients with hematologic malignancies. In a donor stem cell transplant, the donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine the feasibility of escalating dose regimen (EDR) donor lymphocyte infusion (DLI) as measured by the proportion of patients who receive at least one DLI.

SECONDARY OBJECTIVES:

I. To assess progression free survival (PFS) at 2 years after stem cell transplant (SCT) for high-risk hematologic malignancies receiving T-cell depleted grafts followed by escalating dose regimen (EDR) prophylactic DLI compared to historical controls not receiving DLI.

II. To assess the safety of EDR DLI for high-risk hematologic malignancies as measured by cumulative incidence of severe grade III-IV acute graft-versus-host disease (GVHD).

III. To measure outcomes of grade II-IV acute GVHD, non-relapse mortality, overall survival and chronic GVHD of EDR DLI.

IV. To assess the full donor chimerism rate in the CD3 compartment and immune reconstitution after EDR DLI.

OUTLINE:

Patients receive DLI intravenously (IV). Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for 2 years.

02

Conditions studied

  • Accelerated Phase Chronic Myelogenous Leukemia
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Blastic Phase Chronic Myelogenous Leukemia
  • Childhood Burkitt Lymphoma
  • Childhood Chronic Myelogenous Leukemia
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Immunoblastic Large Cell Lymphoma
  • Childhood Myelodysplastic Syndromes
  • Childhood Nasal Type Extranodal NK/T-cell Lymphoma
  • Chronic Phase Chronic Myelogenous Leukemia
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • de Novo Myelodysplastic Syndromes
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Hepatosplenic T-cell Lymphoma
  • Intraocular Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • Noncutaneous Extranodal Lymphoma
  • Peripheral T-cell Lymphoma
  • Post-transplant Lymphoproliferative Disorder
  • Previously Treated Myelodysplastic Syndromes
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Childhood Anaplastic Large Cell Lymphoma
  • Recurrent Childhood Grade III Lymphomatoid Granulomatosis
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Recurrent Small Lymphocytic Lymphoma
  • Recurrent/Refractory Childhood Hodgkin Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Hairy Cell Leukemia
  • Relapsing Chronic Myelogenous Leukemia
  • Secondary Myelodysplastic Syndromes
  • Small Intestine Lymphoma
  • Splenic Marginal Zone Lymphoma
  • T-cell Large Granular Lymphocyte Leukemia
  • Testicular Lymphoma
  • Waldenström Macroglobulinemia
03

In context

Lymphoma, Extranodal NK-T-Cell Reclassified

270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.

This study's enrollment of 77 is above the median of 33 across 225 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.

Browse Lymphoma, Extranodal NK-T-Cell studies →

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.

Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.

Compared within Lymphoma, Extranodal NK-T-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Leukemia, Myeloid, Accelerated Phase. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
14 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • INCLUSION CRITERIA PRIOR TO TRANSPLANT:
  • The clinical trial will be offered to all high risk (defined 3 below) patients with hematologic who require stem cell transplants as part of their standard of care using matched related or unrelated donors
  • Patients with high risk myeloid or lymphoid malignancies at stem cell transplant following American Society for Blood and Marrow Transplantation (ASBMT) criteria, including but not limited to conditions listed; these criteria apply BEFORE cyto-reductive therapy given within 28 days of planned conditioning:

    • acute myelogenous or lymphoid leukemia
    • Relapsed acute myelogenous or lymphoid leukemia
    • Myelodysplastic syndromes with 5% or more blasts
    • Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently, or second accelerated phase
    • Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant
  • High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen
  • DONORS: Matched related or unrelated donor stem cell transplant (SCT) matched at human leukocyte antigen (HLA) A- B, C, and DRB1 by molecular methods; 7 of 8 matched donor acceptable for related donors
  • T-cell depletion with anti-thymocyte globulin (ATG) (rabbit or horse) or at least 30 mg of alemtuzumab total in the conditioning regimen
  • Immune suppression; planned post-transplant immune suppression should include tacrolimus or cyclosporin monotherapy (i.e., calcineurin inhibitor or CN) for alemtuzumab regimens and a second immune suppressant for ATG treated patients; other agents may be used if CN intolerance or toxicity occurs post-transplant
  • Zubrod performance status (PS) 0-2 or equivalent PS
  • Eligible for transplant in the treating physicians' judgment and by institutional standards
  • ELIGIBILITY TO RECEIVE DLI POST-TRANSPLANT:
  • Donor lymphocytes available or able to be collected
  • No evidence of disease by standard morphology; minimal residual disease or molecular evidence of disease will not exclude
  • >= 500/μl
  • count >= 20,000/μl without transfusion for 7 days
  • Serum glutamic oxaloacetic transaminase () and serum glutamate pyruvate transaminase (SGPT) =\< 5 x (ULN)
  • =\< 3 x ULN
  • No evidence of grade II or higher acute or chronic GVHD at initiation of first DLI
  • No systemic or drugs (topical acceptable); replacement steroids for adrenal insufficiency are not excluded

Exclusion Criteria:

  • EXCLUSION CRITERIA PRIOR TO TRANSPLANT:
  • Pregnant or lactating females
  • with positive viral load prior to transplant conditioning or virus
  • Human immune deficiency virus
  • Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give
  • Creatinine >= 2.0 mg/dL
  • SGOT and SGPT >= 5 x ULN; liver preferred for such patients
  • Bilirubin >= 3 x ULN (unless Gilbert's syndrome)
  • Diffusing capacity of the lung for carbon monoxide (DLCO) \< 50% corrected for
  • or shortening fraction \< 40%
  • Unlikely to be able to procure additional donor lymphocytes
Terms in these criteria, in plain language(18)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    Treatment (DLI)

    Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.

    Biological: therapeutic allogeneic lymphocytes · Other: laboratory biomarker analysis

Interventions

06

What researchers measure

Primary outcomes

  1. Percentage of Patients Who Are Able to Receive at Least One DLI Treatment

    Time frame: Up to 2 years

Secondary outcomes

  1. Progression Free Survival (PFS)

    Time to relapse or death as a result of any cause was evaluated at 2 years and the progression free survival rate was reported.

    Time frame: 2 years

  2. Overall Survival (OS)

    Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% CI.

    Time frame: At 2 years

  3. Rate of Acute GVHD (aGVHD) With Any Grade

    Estimated by cumulative incidence method.

    Time frame: At 1 year and 2 year

  4. Rate of Chronic GVHD (cGVHD)

    Estimated by cumulative incidence method.

    Time frame: At 1 year and 2 year

  5. Treatment-related Mortality

    Estimated by cumulative incidence method. Cumulative incidence of treatment-related mortality with relapse of the original disease as the competing risk will be calculated.

    Time frame: At 2 year

07

Results

Posted Aug 7, 2019

Participant flow

Participant flow — Overall Study
MilestoneTreatment (DLI)
Started77
Completed36
Not completed41
Withdrew: Death9
Withdrew: Physician decision17
Withdrew: Relapse12
Withdrew: Gvhd2
Withdrew: Graft failure1

Outcome measures

PrimaryPercentage of Patients Who Are Able to Receive at Least One DLI Treatment
Time frame:
Up to 2 years
Reported as:
Count of participants · Participants
Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
ParticipantsTreatment (DLI)
Percentage of Patients Who Are Able to Receive at Least One DLI Treatment36
SecondaryProgression Free Survival (PFS)

Time to relapse or death as a result of any cause was evaluated at 2 years and the progression free survival rate was reported.

Time frame:
2 years
Reported as:
Number · percentage of patients
Progression Free Survival (PFS)
percentage of patientsTreatment (DLI)
Progression Free Survival (PFS)43 (29 to 63.9)
SecondaryOverall Survival (OS)

Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% CI.

Time frame:
At 2 years
Reported as:
Number · percentage of patients
Overall Survival (OS)
percentage of patientsTreatment (DLI)
Overall Survival (OS)59.7 (44.8 to 79.4)
SecondaryRate of Acute GVHD (aGVHD) With Any Grade

Estimated by cumulative incidence method.

Time frame:
At 1 year and 2 year
Reported as:
Number · percentage of patients
Rate of Acute GVHD (aGVHD) With Any Grade
percentage of patientsTreatment (DLI)
At 1 year41.8 (24.6 to 58.1)
At 2 year41.8 (24.6 to 58.1)
SecondaryRate of Chronic GVHD (cGVHD)

Estimated by cumulative incidence method.

Time frame:
At 1 year and 2 year
Reported as:
Number · percentage of patients
Rate of Chronic GVHD (cGVHD)
percentage of patientsTreatment (DLI)
At 1 year26.6 (12.2 to 43.4)
At 2 year26.6 (12.2 to 43.4)
SecondaryTreatment-related Mortality

Estimated by cumulative incidence method. Cumulative incidence of treatment-related mortality with relapse of the original disease as the competing risk will be calculated.

Time frame:
At 2 year
Reported as:
Number · percentage of patients
Treatment-related Mortality
percentage of patientsTreatment (DLI)
Treatment-related Mortality12.1 (3.7 to 25.9)

Adverse events

Collected over 2 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (DLI)17/36 (47.2%)12/36 (33.3%)1/36 (2.8%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventTreatment (DLI)
DeathGeneral disorders2/36
FeverGeneral disorders2/36
Liver GVHDInvestigations2/36
Bronchopulmonary hemorrhageRespiratory, thoracic and mediastinal disorders1/36
Diarrhea from drugGastrointestinal disorders1/36
DizzinessNervous system disorders1/36
RashSkin and subcutaneous tissue disorders1/36
nervous system disorderNervous system disorders1/36
PneumoniaReproductive system and breast disorders1/36
BurnInjury, poisoning and procedural complications1/36
Most frequent other events
Most frequent other events
EventTreatment (DLI)
SepsisInfections and infestations1/36

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (DLI)
Median53 (20 to 75)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (DLI)
Female26
Male51
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (DLI)
American Indian or Alaska Native0
Asian3
Native Hawaiian or Other Pacific Islander0
Black or African American3
White70
More than one race0
Unknown or Not Reported1
08

Study locations

1 site
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637-1470, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01839916
Responsible party
Sponsor
First posted
Apr 25, 2013
Start date
Apr 4, 2013
Primary completion
Aug 2018
Completion
Aug 2018
Results posted
Aug 7, 2019
Last update
Aug 7, 2019

Study contacts

Hongtao Liu
principal investigator · University of Chicago Comprehensive Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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