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Half-Matched stem cell transplant shows promise for older blood cancer patients

NCT ID NCT04191187

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a stem cell transplant from half-matched (haploidentical) family donors for 34 people with various blood cancers. Patients received a reduced-intensity conditioning regimen of fludarabine, melphalan, and total body irradiation before the transplant. The goal was to see how many patients remained free of their cancer 18 months after the procedure.

What this could mean

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

Active substance
Fludarabine, Melphalan, and total body irradiation
What this could lead to
If successful, this approach could offer a safer transplant option for older or sicker patients with blood cancers who lack a fully matched donor.
What could go wrong
This is a small, single-arm phase 2 trial, so results may not apply broadly. Risks include graft-versus-host disease, infection, and relapse.

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

34 people

The number who actually took part.

Started

Dec 2019

Finished

Feb 2024

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: * Age ≥ 55 years or HCT Co-Morbidity score (HCT-CI) \>/=3 * Lack of a suitable 8/8 HLA-matched sibling donor * Adequate performance status is defined as Karnofsky score ≥ 70% * Patients and selected donor must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1. Donors must be HLA-haploidentical relatives including, but not limited to, children, siblings, or parents, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1. * Acute Myeloid Leukemia (AML): Must be in remission with morphology (\<5% blasts) * Acute Lymphoblastic Leukemia (ALL)/lymphoma second or greater complete remission (CR) first CR unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities, first CR high-risk ALL * Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR * Myelodysplastic syndrome: any subtype including refractory anemia (RA) if severe pancytopenia or complex cytogenetics. Blasts must be less than 5%. If 5% of more requires chemotherapy for cytoreduction to \</=5% prior to transplantation. * Chronic Myelogenous leukemia in accelerated phase: patient must have failed at least two different Tyrosine Kinase Inhibitor (TKI)s, been intolerant to all TKIs, or have T315l mutation * Myeloproliferative neoplasms/myelofibrosis: Blasts must be less than 5%. If 5% or more requires chemotherapy for cytoreduction to \</=5% prior to transplantation * Relapsed large-cell lymphoma, mantle-cell lymphoma or Hodgkin lymphoma that is chemotherapy sensitive and has failed or ineligible for an autologous transplant * Burkitt's lymphoma in second CR or subsequent CR * Relapsed T-cell lymphoma that is chemotherapy sensitive in CR/Partial Response (PR) that has failed or ineligible for an autologous transplant * Natural killer cell malignancies * Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma with any of the following: * Progressed within 12 months of achieving a partial or complete remission Patients who had remissions lasting up * Patients who had remission lasting \> 12 months are eligible after at least two prior therapies * Patients with primary, refractory disease. Bulky disease and an estimated tumor doubling time of less than one month require debulking therapy prior to transplant. * Lymphoplasmacytic lymphoma is eligible after initial therapy if chemotherapy sensitive * Adequate organ function as defined per protocol * Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use adequate birth control during study treatment Exclusion Criteria: * Pregnant or breastfeeding * Untreated active infection * Active HIV infection * Prior allogenic transplant at any time prior or less than 6 months since prior autologous transplant (if applicable) * Active central nervous system malignancy * Favorable risk AML defined as per protocol * Active central nervous system malignancy * Favorable risk AML defined as having one of the following: * t(8,21) without cKIT mutation or evidence of immunophenotypic, cytogenetic or molecular minimal residual disease (MRD) * inv(16) or t(16;16) without cKIT mutation or evidence of MRD * Normal karyotype with mutated NPM1 but FLT3-ITD wild type without evidence of MRD * Normal karyatype with double mutated CEBPA without evidence of MRD

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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

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612, United States

More trials for these conditions

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