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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01042509
Other study ID # HE09-013
Secondary ID
Status Recruiting
Phase N/A
First received January 4, 2010
Last updated January 5, 2010
Start date October 2009
Est. completion date January 2011

Study information

Verified date January 2010
Source Hospital Universitario Dr. Jose E. Gonzalez
Contact Miguel A Gomez-Guijosa, M.D.
Phone +52 81 83 48 61 36
Email magg770214@yahoo.com.mx
Is FDA regulated No
Health authority Mexico: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether low-doses alemtuzumab and rituximab combination are effective in the treatment of chronic graft-versus-host disease (GVHD) after first-line therapy failure.


Description:

Graft-versus-host disease (GVHD) is the most common long-term complication in patients who underwent allogeneic transplantation. First-line therapy for chronic GVHD is based on immunosuppressive agents (usually cyclosporine and corticosteroids) achieving satisfactory response in around 30% of patients. There is no ideal second-line treatment for chronic GVHD; however, numerous studies have been published with therapeutic options such as alemtuzumab (anti-CD52) and rituximab (anti-CD20).

This is a prospective, longitudinal, nonrandomized study in which alemtuzumab and rituximab will be administered at low-doses to patients with refractory chronic GVHD. Clinical response will be evaluated based on the Working Group Report 2006, published by the National Institute of Health Consensus. Follow-up sessions will be weekly for four weeks, every two weeks until achieve response, and finally every four weeks.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date January 2011
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients with chronic graft-versus-host disease.

- Patients over 18 years old.

- Patients who received first-line treatment with no response (failure), relapse or steroid dependance.

Exclusion Criteria:

- Patients with active bacterial or viral infections.

- Patients with hematologic disease progression.

- Patient's intolerance to drugs.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Alemtuzumab and Rituximab combination
Alemtuzumab at 10mg subcutaneously daily for 3 doses (days 1, 2 and 3) Rituximab at 100mg intravenously weekly for 4 doses (days 4, 11, 18 and 25)

Locations

Country Name City State
Mexico Hematology Department of Hospital Universitario Dr Jose E Gonzalez Monterrey Nuevo Leon

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. — View Citation

Martin PJ, Weisdorf D, Przepiorka D, Hirschfeld S, Farrell A, Rizzo JD, Foley R, Socie G, Carter S, Couriel D, Schultz KR, Flowers ME, Filipovich AH, Saliba R, Vogelsang GB, Pavletic SZ, Lee SJ; Design of Clinical Trials Working Group. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group report. Biol Blood Marrow Transplant. 2006 May;12(5):491-505. — View Citation

Pavletic SZ, Martin P, Lee SJ, Mitchell S, Jacobsohn D, Cowen EW, Turner ML, Akpek G, Gilman A, McDonald G, Schubert M, Berger A, Bross P, Chien JW, Couriel D, Dunn JP, Fall-Dickson J, Farrell A, Flowers ME, Greinix H, Hirschfeld S, Gerber L, Kim S, Knobler R, Lachenbruch PA, Miller FW, Mittleman B, Papadopoulos E, Parsons SK, Przepiorka D, Robinson M, Ward M, Reeve B, Rider LG, Shulman H, Schultz KR, Weisdorf D, Vogelsang GB; Response Criteria Working Group. Measuring therapeutic response in chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. Response Criteria Working Group report. Biol Blood Marrow Transplant. 2006 Mar;12(3):252-66. — View Citation

Ruiz-Argüelles GJ, Gil-Beristain J, Magaña M, Ruiz-Delgado GJ. Alemtuzumab-induced resolution of refractory cutaneous chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2008 Jan;14(1):7-9. Epub 2007 Dec 3. — View Citation

von Bonin M, Oelschlägel U, Radke J, Stewart M, Ehninger G, Bornhauser M, Platzbecker U. Treatment of chronic steroid-refractory graft-versus-host disease with low-dose rituximab. Transplantation. 2008 Sep 27;86(6):875-9. doi: 10.1097/TP.0b013e318183f662. — View Citation

Zaja F, Bacigalupo A, Patriarca F, Stanzani M, Van Lint MT, Filì C, Scimè R, Milone G, Falda M, Vener C, Laszlo D, Alessandrino PE, Narni F, Sica S, Olivieri A, Sperotto A, Bosi A, Bonifazi F, Fanin R; GITMO (Gruppo Italiano Trapianto Midollo Osseo). Treatment of refractory chronic GVHD with rituximab: a GITMO study. Bone Marrow Transplant. 2007 Aug;40(3):273-7. Epub 2007 Jun 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate clinical response of alemtuzumab and rituximab combination in patients with refractory chronic GVHD based on the Working Group Report 2006. 90 days and 1 year Yes
Secondary Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation. 90 days and 1 year Yes
Secondary Measuring the response time achieved with the combination of alemtuzumab and rituximab through clinical evaluation. 90 days and 1 year Yes
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