ClinicalTrials.gg
CompletedNCT01597219UK-HaploUpdated May 3, 2024

Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers

A Phase 2 interventional study of Reduced intensity haplodentical stem cell transplant and Myeloablative haploidentical stem cell transplant in Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma and Acute Myeloid Leukaemia, sponsored by University College, London. Completed at 12 sites in United Kingdom. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-03.

Sponsored by University College, London · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
77
Allocation
Non-randomized
Ages
16 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Hodgkin Disease by University College, London — 2 open to participants now, 5 under way, 2 of them phase 3. Hodgkin Disease · University College, London.

Started
2013
the only one that year
Phase 2
6 of 10
1 open now
Registered
6th of 10
by date

Among the 10 studies in Hodgkin Disease by University College, London, this one is the only one that started in 2013, is one of 6 in phase 2, and was the 6th registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

Phase 2this study6 · 1 open
Phase 33 · 1 open
Observational1 · 0 open

By the year they started

First in 2003; this study’s year is marked. 1 started in 2013.

Size and results

Median enrollment 80 across the 9 interventional studies, 58 across the 1 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 10 studies in Hodgkin Disease by University College, London, or all of them as a file.
02

Study summary

This trial investigates stem cell transplants from partially mismatched donors in patients with blood and bone marrow cancers. The trial will test two kinds of transplants - a full intensity transplant using a high dose of radiotherapy and chemotherapy, and a reduced intensity transplant with lower doses of chemotherapy and radiotherapy. Patients will be entered for the treatment pathway that is most appropriate for their level of health and fitness

03

Conditions studied

  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Acute Myeloid Leukaemia
  • Acute Lymphoblastic Leukaemia
  • Myelodysplastic Syndrome
  • Chronic Myeloid Leukaemia
  • Chronic Lymphocytic Leukaemia
  • Acquired Bone Marrow Failure Syndromes
  • Other Haematological Malignancies; Unrelated HSCT Indicated

Keywords

  • Haploidentical transplant
  • Haematological malignancy
  • Myeloablative
  • Reduced intensity
04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Patient Inclusion Criteria

  1. Eligible for an transplant in line with the current BSBMT indications for transplant criteria (http://bsbmt.org/indications-table/) accepted by Commissioners
  2. Age 16-70
  3. Adequate physical function

    • Cardiac: at rest ≥45%, or shortening fraction ≥25%
    • Hepatic: ≤35mmol/l; /ALT and alkaline phosphatase \<5 x
    • Renal: Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, or >40ml/min/1.73m2
    • Pulmonary: , FVC, DLCO (diffusion capacity) >50% predicted (corrected for ); if clinically unable to perform pulmonary function tests then O2 saturation >92% on room air
    • Performance status: score ≥60%
  4. Donor available aged ≥16 years
  5. Needs an urgent transplant where a 10/10 HLA matched sibling or unrelated donor is unavailable in a timely manner. An unrelated donor search is not required for a patient to be eligible if the clinical situation dictates an urgent transplant. Clinical urgency is defined as 6-8 weeks from referral to transplant centre or low likelihood of finding a matched unrelated donor
  6. HLA typing will be performed at high resolution (allelic) for the HLA-A, HLA-B, HLA-Cw, HLA-DRB1 and HLA-DQB1 loci. A minimum match of 5/10 is required
  7. The donor and recipient must be identical as determined by high resolution typing at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1 and HLA-DQB1. Fulfilment of this criterion is sufficient evidence that the donor and recipient share one HLA haplotype and typing of additional family members is not required.
  8. Patient must have received cytotoxic chemotherapy within 3 months of the consent date (measured from the start date of the most recent cycle of chemotherapy) except patients with aplastic anaemia, unless otherwise agreed by the TMG (see section 5.3.4). The use of monoclonal antibody therapy may be considered cytotoxic chemotherapy, but must be agreed by the TMG
  9. Written

Donor Inclusion Criteria

  1. Donor must be an HLA-haploidentical first degree relative of the patient. Eligible donors include biological parents, siblings, children or half-siblings
  2. Age ≥16 years
  3. Donors must meet the collection centre's usual selection criteria for related allogeneic HPC donors

Patient Exclusion Criteria

  1. HLA matched, related donor able to donate
  2. Autologous haematopoietic stem cell transplant \<3 months prior to enrolment
  3. Pregnancy or breastfeeding
  4. Uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiological findings), the inclusion of patients with an uncontrolled viral or fungal infection can be agreed by the TMG
  5. Serious psychiatric or psychological disorders
  6. Absence or inability to provide informed consent
  7. Severe comorbidity (HCT-CI comorbidity score of 3 or more) or disease that prevents treatment with chemotherapy, unless otherwise agreed by the TMG
  8. Positive anti-donor HLA antibody
  9. Unable to receive 2Gy TBI (RIC pathway) or 12Gy TBI (MAC pathway)
  10. Patients with graft rejection following a previous allograft from either adult or cord blood donors

Donor Exclusion Criteria

  1. Positive anti-donor HLA antibody in the recipient
  2. Pregnancy or recent birth (within 6 months prior to donating cells)
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    Reduced intensity haploidentical transplant

    Fludarabine 30mg/m2 IV days -6 to -2 Cyclophosphamide 14.5 mg/kg IV days -6 and -5 Total body irradiation 2Gy day -1 Stem cell transplant: day 0 Cyclophosphamide 50mg/kg days +3 \& +4

    Procedure: Reduced intensity haplodentical stem cell transplant

  • Experimental
    Myeloablative haploidentical stem cell transplant

    Total body irradiation 12Gy in 8 fractions days -9 to -6 Donor lymphocyte infusion day -6 Cyclophosphamide 60mg/kg IV days -3 \& -2 Stem cell transplant day 0

    Procedure: Myeloablative haploidentical stem cell transplant

Interventions

  • ProcedureReduced intensity haplodentical stem cell transplant

    Fludarabine 30mg/m2 IV days -6 to -2 Cyclophosphamide 14.5 mg/kg IV days -6 and -5 Total body irradiation 2Gy day -1 Stem cell transplant: day 0 Cyclophosphamide 50mg/kg days +3 \& +4

  • ProcedureMyeloablative haploidentical stem cell transplant

    Total body irradiation 12Gy in 8 fractions days -9 to -6 Donor lymphocyte infusion day -6 Cyclophosphamide 60mg/kg IV days -3 \& -2 Stem cell transplant day 0

06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: 1 year post transplant

07

Study locations

12 sites
  • Birmingham Heartlands
    Birmingham, United Kingdom
  • Bristol Royal Infirmary
    Bristol, United Kingdom
  • Addenbrooke's Hospital
    Cambridge, United Kingdom
  • Beatson Hospital
    Glasgow, United Kingdom
  • St James' University Hospital
    Leeds, United Kingdom
  • Royal Liverpool Hospital
    Liverpool, United Kingdom
  • King's College Hospital
    London, United Kingdom
  • St Bartholomew's Hospital
    London, United Kingdom
  • University College Hospital
    London, United Kingdom
  • Manchester Royal Infirmary
    Manchester, United Kingdom
  • Freeman Hospital
    Newcastle, United Kingdom
  • Royal Hallamshire, Sheffield & Weston Park
    Sheffield, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2013, a primary completion of Jan 2024 and a completion of Jan 2024. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2012
First posted
May 11, 2012
Start
Mar 2013
Primary completionActual
Jan 2024
CompletionActual
Jan 2024
Last update
May 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01597219
Collaborators
Bloodwise
Responsible party
Sponsor
First posted
May 11, 2012
Start date
Mar 2013
Primary completion
Jan 2024
Completion
Jan 2024
Last update
May 3, 2024

Study contacts

Dr Kavita Raj
principal investigator · King's College Hospital NHS Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion