A Phase 4 interventional study of Bleomycin (Bleocel 15) in Vascular Malformations, Venous Malformation and Lymphatic Malformation, sponsored by University Of Anbar. Completed at 3 sites in Iraq. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by University Of Anbar · Phase 4, Interventional, and Treatment
This study evaluated lesion volume reduction after intralesional bleomycin sclerotherapy in patients with low-flow vascular malformations of the head and neck, and identified predictors of treatment response. Twenty patients were enrolled across three Iraqi teaching hospitals and treated with intralesional bleomycin. Lesion volume was assessed by ultrasound or MRI at baseline and four weeks after the final treatment session.
Patients with clinically and radiologically confirmed low-flow vascular malformations of the head and neck were enrolled consecutively. Bleomycin was diluted to 3 mg/mL and injected intralesionally at multiple points, with a maximum of 15 mg per session and up to four sessions at three- to four-week intervals. Needle selection was guided by lesion depth, with ultrasound guidance used for deeper lesions. Lesion dimensions (length, width, depth) were measured by a single trained operator at each site; volume was calculated using the prolate ellipsoid formula (pi/6 x L x W x D), or by MRI-based volumetric segmentation for irregular multilocular lesions. Clinical response was graded using the modified Achauer scale. Adverse events were graded using CTCAE version 5.0, and peripheral oxygen saturation was monitored during and after each procedure.
79 studies on the registry are indexed under Vascular Malformations; 33 are open to participants now.
This study's enrollment of 20 is below the median of 55 across 49 interventional studies indexed under Vascular Malformations.
Browse Vascular Malformations studies →University Of Anbar is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants received intralesional bleomycin sclerotherapy.
Drug: Bleomycin (Bleocel 15)
Intralesional injection of bleomycin diluted with normal saline to 3 mg/mL. Maximum 15 mg per session; up to four sessions at three- to four-week intervals; cumulative dose capped at 400 mg. Administered under local anaesthesia or conscious sedation, with ultrasound guidance for deep lesions.
Percentage reduction in lesion volume
Lesion volume derived from three orthogonal dimensions using the prolate ellipsoid formula (pi/6 x length x width x depth) on ultrasound or MRI, or by MRI volumetric segmentation for irregular lesions. Percentage reduction calculated relative to baseline volume.
Time frame: Baseline to 4 weeks after the final treatment session
Incidence and severity of adverse events
Adverse events documented and graded using CTCAE version 5.0, including monitoring of peripheral oxygen saturation for pulmonary safety
Time frame: From the first treatment session through 4 weeks after the final treatment session, up to 16 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
Studies of the drug tested here: Bleomycin
University Of Anbar