Substituting the drug, alemtuzumab, for another drug known as ATGAM (Antithymocyte Globulin - equine), as part of combination therapy for steroid-refractory acute graft versus host disease in post haematopoietic progenitor cell transplantation patients.

Substitution of alemtuzumab for ATGAM (Antithymocyte Globulin - equine) as part of combination therapy including etanercept, tacrolimus and mycophenolate mofetil for steroid-refractory acute graft versus hosts disease (SR-GVHD) post haematopoietic progenitor cell transplantation (HPCT): evaluation of treatment response and survival at 6 months

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000288729

Enrollment

Registered

2013-03-13

Start date

2012-11-12

Completion date

2014-06-27

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is evaluating the efficacy of substituting the drug, alemtuzumab, for another drug known as ATGAM, as part of combination therapy for steroid-refractory acute graft versus host disease in post haematopoietic progenitor cell transplantation patients. Who is it for? You may be eligible to join this study if you are a male or female aged between 18-69 years who has been diagnosed with grade II or higher steroid-refractory acute graft versus host disease (SR-GVHD) following haematopoietic progenitor cell transplantation (HPCT). Trial details All participants in this trial will be given the drug alemtuzumab for 5 consecutive days. Alemtuzumab will be administered intravenously (into the vein) over a period of 2 hours each day. All patients will also receive standard premedication (including paracetamol, phenergan and hydrocortisone) 30 minutes prior to alemtuzumab. Participants will be assessed at 6 months in order to evaluate response to treatment and survival.

Interventions

Alemtuzumab given for 5 consecutive days, in 250 mls of Normal Saline over 2 hours. Dose is fixed at 5mg IV per day in all patients, irrespective of weight. All patients will recieve standard premedication with two paracetamol orally, phenergen 12.5mg intravenously and hydrocortisone 100mg intravenously 30 minutes prior to alemtuzumab.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 69 Years

Healthy volunteers

Inclusion criteria

*Age greater than18 and less than 70 years *Patients must suffer SR-GVHD, as defined by: #Progressive disease (i.e any new organ involvement and/or worsening by greater than or equal to 1 grade of GVHD) after 3 days of therapy with prednisolone (or equivalent) at greater than or equal to 1mg/kg/day, and / or #No change in GVHD grade after 7 days of therapy with prednisolone (or equivalent) at greater than 1mg/kg/day, and / or #Incomplete response (i.e less than CR) after 14 days of primary therapy with prednisolone (or equivalent) at greater than 1mg/kg/day and / or #Recurrence of GVHD (greater than grade 1) on steroid taper while receiving grater than 0.5mg/kg of prednisolone (or equivalent) per day. #GVHD diagnosis must be proven by histological assessment of target organ biopsy. #GVHD grade must be greater than II as per Glucksberg criteria. #Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

*Patients receiving any other investigational agents. *Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. *HIV, HCV and HBV infection. *Pregnancy, or refusal to use adequate contraception to prevent pregnancy. *History of allergic reactions attributed to compounds of similar chemical or biologic composition as alemtuzumab or other agents used in the study. *Patients with known human anti-mouse antibodies (HAMA).

Outcome results