Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New transplant method aims to reduce dangerous immune reactions

NCT ID NCT03192397

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a stem cell transplant method for people with blood cancers like leukemia or lymphoma. The approach uses chemotherapy, total body radiation, and a drug called cyclophosphamide after the transplant to prevent graft-versus-host disease, where donor cells attack the patient's body. The trial includes 35 participants and aims to see if this combination reduces severe long-term complications.

What this could mean

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

Active substance
cyclophosphamide
What this could lead to
If successful, this approach could lower the risk of graft-versus-host disease, making stem cell transplants safer and more effective for blood cancer patients.
What could go wrong
This is an early-phase trial with only 35 participants, so results may not apply to everyone. The treatment involves strong chemotherapy and radiation, which can cause serious side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

35 people

The number who actually took part.

Started

Aug 2017

Expected to finish

May 2027

An estimate. End dates often move.

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * The patient must have a diagnosis of one of the following (one must be yes): * Acute myeloid leukemia (AML) * Acute lymphoblastic leukemia (ALL) * Chronic lymphoblastic leukemia (CLL) * Chronic myelogenous leukemia (CML) (chronic phase intolerant or unresponsive to tyrosine kinase inhibitors, accelerated phase, history of blast crisis) * Myelodysplastic syndrome (MDS) * Non-Hodgkin lymphoma (NHL) * Hodgkin lymphoma (HL) (received and failed frontline therapy or failed autologous transplantation or inability to collect enough peripheral blood stem cells \[PBSC\] for autologous hematopoietic cell transplant \[auto-HCT\]) * Multiple myeloma (MM) * Severe aplastic anemia * Histocompatible donor identified: * Related donor matched 5/6 or better (A, B, DRB1) * Unrelated donor matched 7/8 or better (A, B, C and DRB1) * Patients with severe aplastic anemia do not have disease requirements; however, if the patient has a mismatched donor, the patient must have had prior therapy with ATG. The following are eligible for study inclusion: * Patients with MDS/MPN only require \<5% myeloblast on bone marrow evaluation. * Patients with AML, ALL or CLL may be in CRi, patients with MM may be in VGPR * Patients with NHL/HL must be in CR * Have a Karnofsky performance status score of \> 50% * Diffusing capacity of the lung for carbon monoxide (DLCO) \> 40% predicted, corrected for hemoglobin and/or alveolar ventilation * Left ventricular ejection fraction \> 40% * Bilirubin =\< 3 x upper limit of normal * Liver alkaline phosphatase =\< 3 x upper limit of normal * Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =\< 3 x upper limit of normal * Calculated creatinine clearance \> 40 cc/min by the modified Cockroft-Gault formula * Patient must be cleared pre-transplant by Radiation Oncology to be able to receive 400 cGy * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Patients who have failed a prior autologous or allogeneic transplant are eligible; however, at least 6 months must have elapsed between the start of this reduced intensity conditioning regimen and the last transplant if patient had a prior autologous or myeloablative allogeneic bone marrow transplant (BMT) * At least 2 weeks since prior radiation treatment and/or surgery. Appropriate washout of prior chemotherapy per BMT standard of care. If medication is not on the list, go by physician discretion * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Moderate to severe myelofibrosis within 60 days prior to transplant * Presence of human leukocyte antigen (HLA) antibodies to the donor within 60 days prior to transplant * Patients who in the opinion of the treating physician are unlikely to comply with the restrictions of allogeneic stem cell transplantation based on formal psychosocial screening. (i.e., serious, uncontrolled psychiatric illness/social situations that would limit compliance with study requirements) * Uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other condition which, in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient * Known human immunodeficiency virus (HIV) positive * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute lymphoblastic leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

More trials for these conditions

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