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Selective immune cell removal may tame transplant complications

NCT ID NCT02220985

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether removing a specific type of immune cell (naïve T cells) from donor stem cell grafts could prevent graft-versus-host disease (GVHD) after a stem cell transplant for blood cancers. The trial enrolled 84 patients who received high- or medium-intensity chemotherapy and radiation before transplant. The goal was to reduce GVHD while keeping the donor cells' ability to fight infections and cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Allogeneic hematopoietic stem cell transplantation with selective depletion of CD45RA+ T cells
What this could lead to
If successful, this approach could reduce the severity of graft-versus-host disease while preserving the donor cells' ability to fight infections and cancer, improving outcomes for stem cell transplant recipients.
What could go wrong
This is a phase II trial with a moderate number of participants, so results may not be definitive. The procedure is complex and carries risks such as graft failure, infection, or relapse of the underlying cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

84 people

The number who actually took part.

Started

Mar 2015

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients who are considered appropriate candidates for allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses: * Acute lymphocytic leukemia in first or subsequent remission * Acute myeloid leukemia in first or subsequent remission * Acute lymphocytic leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm\^3 (Arms A or C only) * Acute myeloid leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm\^3 (Arms A or C only) * Refractory anemia with excess blasts (RAEB-1 and RAEB-2) (if the patient has received previous induction chemotherapy within 60 days) * Chronic myelogenous leukemia with a history of accelerated phase or blast crisis (if the patient has received at least one course of induction chemotherapy) * Other acute leukemia or related neoplasm (including but not limited to 'biphenotypic', 'undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm or lymphoblastic lymphoma) * Patients 0-49 years old will be enrolled in Arm A or C (high-intensity) * Patients 50-60 years old will be enrolled in Arm B or D (lower intensity); patients eligible for Arms B or D also include those who have received previous allogeneic HCT, or who have co-morbid conditions rendering them unsuitable for high-dose conditioning, determined in consultation with the principal investigator * Patient with a HLA-matched (HLA-A, B, C, and DR beta 1 \[DRB1\] molecularly matched) unrelated donor or related donor capable of donating PBSC * DONOR INCLUSION: * HLA-matched related donors \>= 18 years and capable and willing to donate PBSC (Arms A and B) * HLA-matched unrelated donors (HLA-A, B, C, and DRB1 matched based on high-resolution typing) capable and willing to donate PBSC (Arms C and D) Exclusion Criteria: * Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation * Patients on other experimental protocols for prevention of acute GVHD * Patient weight \>= 100 kg; patients \>= 70 kg with MUDs must be discussed with the principal investigator * Patients who are human immunodeficiency virus positive (HIV+) * Patients with uncontrolled infections for whom myeloablative HCT is considered contraindicated by the consulting infectious disease physician (upper respiratory tract viral infection does not constitute an uncontrolled infection in this context) * Patients with organ dysfunction * ARM A OR C EXCLUSION: * Creatinine \> 1.5 mg/dl at the present time; patients with a known history of creatinine \> 1.5 mg/dl must have a current estimated creatinine clearance of \> 40 ml/min * Cardiac ejection fraction \< 45% * Diffusing capacity of the lung for carbon monoxide (DLCO) corrected \< 60%; patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the oxygen (O2) saturation is \< 92% on room air * Liver function abnormality; patients who have liver function tests (LFTs) (including total bilirubin, aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) \>= twice the upper limit of normal should be evaluated by a gastrointestinal (GI) physician; unless there is a clear precipitating factor (such as an azole, methotrexate, Bactrim or another drug); if the GI physician considers that HCT on the high-intensity arms of protocol is contraindicated for that patient the patient may be considered for treatment on the lower intensity arm of the protocol or excluded from the protocol; patients with Gilbert's syndrome and no other known liver function abnormality and patients with reversible drug-related transaminitis do not necessarily require GI consultation and may be included on the high-intensity arms of the protocol * ARM B OR D EXCLUSION: * Creatinine \> 2.0 mg/dl at the present time; patients with a known history of creatinine \> 1.5 mg/dl must have a current estimated creatinine clearance \> 40 ml/min * Cardiac ejection fraction \< 35% * DLCO corrected \< 50%; patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the O2 saturation is \< 92% on room air; patients with a DLCO 50-60% must also have a partial pressure of oxygen (pO2) of \> 80 mmHg * Liver function abnormality; patients who have LFTs \>= twice the upper limit of normal should be evaluated by a GI physician unless there is a clear precipitating factor (such as an azole, methotrexate, Bactrim or another drug); patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3 mg/dL, and symptomatic biliary disease will be excluded * Patients will be excluded from Arms A and C if they have received a previous myeloablative transplant; patients who have received a prior HCT at least 6 months prior may be considered for inclusion on Arms B or D after discussion with the principal investigator (PI) * Patients with a life expectancy \< 3 months from co-existing disease other than the leukemia or RAEB * Patients who are pregnant or breast-feeding * Fertile patients of child bearing age unwilling to use contraception during and for 12 months post-transplant * Patients with a significant other medical conditions that would make them unsuitable for transplant * Patients with a known hypersensitivity to tacrolimus, methotrexate (Arm A or C) or MMF (Arm B or D) * DONOR EXCLUSION: * Donors who are HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection * Donors who fail eligibility requirements for donation of cells or tissue for donation of a Human Cell and Tissue Products (HCT/P) will be excluded unless use of the cells complies urgent medical need or allogeneic use in a first-degree or second-degree relative * Unrelated donors donating outside of the United States of America (USA)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.