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New trial aims to stop leukemia relapse after transplant

NCT ID NCT03821610

Disease control Sponsor: University of Birmingham 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial compares two different chemotherapy and radiation regimens given before a stem cell transplant for adults aged 40-70 with acute lymphoblastic leukemia (ALL) in remission. The goal is to see if a stronger regimen (using total body irradiation and cyclophosphamide) can reduce the chance of the cancer returning without increasing the risk of dying from the transplant. About 242 patients will be randomly assigned to one of the two regimens and followed for at least 3 years.

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, Alemtuzumab, Cyclophosphamide, Mesna, Total Body Irradiation (8Gy)
What this could lead to
If successful, this could identify a better pre-transplant regimen that reduces the chance of leukemia returning after a stem cell transplant.
What could go wrong
This is a Phase 2 trial, so results are still preliminary. The stronger regimen may increase side effects or transplant-related deaths, and it may not work for all patients.

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

About 242 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2018

Expected to finish

Nov 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

40 to 70 years

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: * Patients between the ages of 40-70 years. NB: Patients under the age of 40 who are considered unsuitable for a myeloablative transplant may enrol onto the trial following discussion with the CI via the Trials Office * Patients with ALL in first or second CR * Availability of a human leukocyte antigen (HLA) identical sibling or suitable matched donor (suitable matched defined as no greater than a single allele mismatch at HLA A, B, C or DRβ1). A single allele mismatch is permitted if there are adverse cytogenetics or MRD positivity at any timepoint * Patients considered suitable to undergo a RIC allogeneic SCT as clinically judged by the Local Investigator including:- * Adequate hepatic and renal function as determined by full blood count and biochemistry assessment * Resolution of any toxic effects of prior therapy (including radiotherapy, chemotherapy or surgical procedures). Patients with bone marrow suppression following therapy may enter the trial * Patients with abnormal cardiac and/or pulmonary function must be considered fit for allogeneic SCT including 8Gy of TBI at the time of randomisation. * Patients with an ECOG performance status 0,1 or 2 * Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must use appropriate, highly effective, contraception from the point of admission for transplant conditioning therapy until 12 months after transplant (see section 8.1.2.2) * Patients have given written informed consent * Patients willing and able to comply with scheduled study visits and laboratory tests Exclusion Criteria: * Patients with contraindications to receiving RIC allogeneic SCT * Female patients who are pregnant or breastfeeding. All women of childbearing potential (WOCBP) must have a negative pregnancy test before commencing treatment * Adults of reproductive potential not willing to use appropriate, effective, contraception during the specified period * Patients with renal or hepatic impairment as clinically judged by Local Investigator * Patients with active infection, HIV-positive or chronic active Hep-A or -C * Patients with concurrent active malignancy. Patients with a previous history of malignancy can be included if that malignancy is considered to be at a low risk of recurrence * Previous exposure to a high dose of radiotherapy

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia 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

Contacts and locations

Locations

  • Barts Health Nhs Trust

    London, E11BB, United Kingdom

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, CB20QQ, United Kingdom

  • Cardiff and Vale University Health Board

    Cardiff, CF144XW, United Kingdom

  • Central Manchester University Hospitals Nhs Foundation Trust

    Manchester, United Kingdom

  • Heart of England Nhs Foundation Trust

    Birmingham, B95ST, United Kingdom

  • Imperial College Healthcare Nhs Trust

    London, W21NY, United Kingdom

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Leeds Teaching Hospitals Nhs Trust

    Leeds, LS9 7TF, United Kingdom

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0YN, United Kingdom

  • Nottingham University Hospitals Nhs Trust

    Nottingham, NG72UH, United Kingdom

  • Oxford University Hospitals Nhs Foundation Trust

    Oxford, OX3 9DU, United Kingdom

  • Plymouth Hospitals Nhs Trust

    Plymouth, PL68DH, United Kingdom

  • Sheffield Teaching Hospitals Nhs Foundation Trust

    Sheffield, S57AU, United Kingdom

  • The Christie Nhs Foundation Trust

    Manchester, M204BX, United Kingdom

  • The Clatterbridge Cancer Centre Nhs Foundation Trust

    Liverpool, CH634JY, United Kingdom

  • The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

    Newcastle, United Kingdom

  • The Royal Marsden Nhs Foundation Trust

    London, SW3 6JJ, United Kingdom

  • University College London Hospitals Nhs Foundation Trust

    London, NW12PG, United Kingdom

  • University Hospital Southampton Nhs Foundation Trust

    Southampton, SO16 6YD, United Kingdom

  • University Hospitals Birmingham Nhs Foundation Trust

    Birmingham, United Kingdom

  • University Hospitals Bristol Nhs Foundation Trust

    Bristol, BS13NU, United Kingdom

  • University Hospitals of Leicester Nhs Trust

    Leicester, LE15WW, United Kingdom

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