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New blood test could spot cancer return after transplant

NCT ID NCT04635384

Knowledge-focused Sponsor: CareDx Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study is testing a new blood test called AlloHeme that measures how much of a patient's own cells remain after a bone marrow transplant. The goal is to see if this test can predict whether the cancer (acute leukemia or myelodysplastic syndrome) will come back. About 307 adults who are getting a transplant will provide blood and bone marrow samples before and after the procedure. The test looks at tiny amounts of leftover patient cells, which might signal a higher risk of relapse.

What this could mean

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

Active substance
AlloHeme test (a blood test using next-generation sequencing to measure donor and recipient cells)
What this could lead to
If successful, this test could help doctors detect relapse earlier after transplant, potentially improving treatment timing and outcomes.
What could go wrong
This is an observational study, not a treatment trial. The test may not reliably predict relapse, and results may not apply to all patients or transplant types.
Why investors are watching

CareDx is running a 307-patient study of its AlloHeme test, which uses DNA sequencing to track whether donor or recipient cells dominate after a bone marrow or stem cell transplant. For a small company like CareDx, this readout matters because it tests whether AlloHeme can reliably detect early signs of relapse in patients with AML or MDS, a potential new use for their existing transplant-monitoring technology. A clear result could broaden the test's clinical role and strengthen the company's position in post-transplant care.

If it works: If the study shows AlloHeme accurately measures chimerism in specific cell types and catches relapse early, CareDx could market the test to more transplant centers and expand its revenue base beyond its current products. That would give the company a stronger story for its transplant diagnostics franchise.

If it fails: If the trial fails to show AlloHeme performs well, or if enrollment or data collection stalls, CareDx may struggle to convince doctors to adopt the test for relapse monitoring. Trials often fail or produce unclear results, and a setback here could slow the company's growth plans without a clear alternative.

AI-written from the trial record. Speculative, and not investment advice.

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.

Participants

307 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Participants aged \> 18 years old with a diagnosis of AML, ALL, and MDS who will undergo an Allo-HCT will be invited to participate and enrolled into the study at the time initial transplant evaluation or at any time before admission for transplantation.

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: * Male or female, aged 18 years or above. * The patient must have one of the following diseases: AML, ALL or MDS * Eligible for allogeneic hematopoietic stem cell transplant * Subjects must receive an Allo-HCT from an HLA matched related or unrelated donor or haploidentical donor * Myeloablative or reduced intensity/non-myeloablative conditioning * Any GVHD prophylaxis regimen including post-transplantation cyclophosphamide-based or conventional regimen * The subject must be enrolled prior to Allo-HCT Exclusion Criteria: The participant may not enter the study if ANY of the following apply: * Has history of prior Allo-HCT * T cell depleted transplant (Including in vivo and ex vivo T cell depletion) * Inability to comply with medical recommendations or follow-up * Donor is identical twin * Pregnancy

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloid leukemia myelodysplastic syndrome Myelodysplastic Syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Acute lymphoblastic leukemia Acute myeloid leukemia Myelodysplastic syndrome

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912, United States

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • University of California Irvine

    Brisbane, California, 94005, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63110, United States

More trials for these conditions

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