Phase 1
Completed N=13
Campath in Chronic GVHD
Chronic Graft-vs.-Host Disease
Source: ClinicalTrials.gov NCT00495755 ↗
Enrolled (actual)
13
Serious AEs
46.2%
Results posted
Aug 2013
Primary outcomePrimary: The Maximum Tolerated Dose (MTD) of a Four-week Course of Alemtuxumab in Chronic GVHD for Patients With an Incomplete Response to Steroids — 53 mg
Summary
The CD52 antigen, which is targeted by alemtuzumab, is highly expressed on mature T lymphocytes, monocytes and monocyte-derived dendritic cells as well as on mature B cells. Due to its more promiscuous effect on immune cells, alemtuzumab not only targets antibody producing B lymphocytes as does rituximab, but also targets alloreactive T lymphocytes and dendritic cells that also contribute to the complex pathogenesis of chronic GVHD.
Our hypothesis is that alemtuzumab will be effective in the treatment of chronic GVHD through its promiscuous depletion of alloreactive T lymphocytes, dendritic cells as well as antibody producing mature B-lymphocytes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Maximum Tolerated Dose (MTD) of a Four-week Course of Alemtuxumab in Chronic GVHD for Patients With an Incomplete Response to Steroids |
53 | — |
| SECONDARY The Efficacy of a Four-week Course of Alemtuzumab in Patients With Steroid-refractory Chronic GVHD (cGVHD). |
3; 4; 2; 1 | — |
| SECONDARY The Effect of Alemtuzumab Therapy on Parameters of Cellular and Humoral Immunity in the Late Post Transplant Period. This Information is Exploratory in Nature Only Due to the Heterogeneity of the Anticipated Patient Population. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Recipients of allogeneic stem cell transplantation using myeloablative or non-myeloablative conditioning regimens.
- Patients must be at least 180 days (6 months) from the allogeneic stem cell transplantation procedure.
- Patients must have steroid refractory chronic GVHD, defined as having persistent signs and symptoms of chronic GVHD despite the use of prednisone at 1000/mm3
- Platelets>50,000/mm3
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment
Exclusion Criteria
- Prednisone requirement>2mg/kg/day or equivalent
- Known life-threatening hypersensitivity to alemtuzumab, other anti-B cell or anti-T cell antibodies.
- Prior exposure to any new immunosuppressive medication (or Extra Corporeal Phototherapy) in the preceding 4 weeks prior to enrollment.
- Active, uncontrolled infection.
- History of Hepatitis B or C infection.
- Active malignant disease relapse.
- Donor lymphocyte infusion within the preceding 100 days or plan for donor lymphocyte infusion in the coming 3 months.
- Life expectancy <3 months.
- Pregnancy or lactation.
- Evidence of HIV seropositivity.
- Inability to comply with alemtuzumab treatment regimen.
Data sourced from ClinicalTrials.gov (NCT00495755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.