Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease

NCT01042509 | Completed Results DMC

• 1 other identifier: HE09-013
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Graft vs Host Disease

Keywords

Chronic Graft vs Host Disease; Alemtuzumab; Rituximab; Low-dose; Alemtuzumab and rituximab combination

Outcome Measures

Primary Outcomes (1)

• Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006.

  Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up

  30, 90 and 365 days

Secondary Outcomes (1)

• Side Effects

  365 days

Study Arms (1)

Alemtuzumab and rituximab

EXPERIMENTAL

Patients with chronic GVHD after first-line therapy failure will receive 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. THE STUDY HAVE ONLY ONE ARM.

Drug: Alemtuzumab and rituximab

Interventions

Alemtuzumab and rituximab DRUG

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

Also known as: Campath, Rituxan

Alemtuzumab and rituximab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with active bacterial or viral infections.
• Patients with hematologic disease progression.
• Patient's intolerance to drugs.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hematology Department of Hospital Universitario Dr Jose E Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (7)

• 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. doi: 10.1016/j.bbmt.2005.09.004.

  PMID: 16338616 BACKGROUND

• 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. doi: 10.1016/j.bbmt.2006.01.008.

  PMID: 16503494 BACKGROUND

• 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. doi: 10.1016/j.bbmt.2006.03.004.

  PMID: 16635784 BACKGROUND

• Ruiz-Arguelles GJ, Gil-Beristain J, Magana 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. doi: 10.1016/j.bbmt.2007.09.013. Epub 2007 Dec 3.

  PMID: 18158955 BACKGROUND

• Zaja F, Bacigalupo A, Patriarca F, Stanzani M, Van Lint MT, Fili C, Scime 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. doi: 10.1038/sj.bmt.1705725. Epub 2007 Jun 4.

  PMID: 17549053 BACKGROUND

• von Bonin M, Oelschlagel 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.

  PMID: 18813113 BACKGROUND

• Gutierrez-Aguirre CH, Cantu-Rodriguez OG, Borjas-Almaguer OD, Gonzalez-Llano O, Jaime-Perez JC, Solano-Genesta M, Gomez-Guijosa M, Mancias-Guerra C, Tarin L, Gomez-Almaguer D. Effectiveness of subcutaneous low-dose alemtuzumab and rituximab combination therapy for steroid-resistant chronic graft-versus-host disease. Haematologica. 2012 May;97(5):717-22. doi: 10.3324/haematol.2011.054577. Epub 2011 Dec 1.

  PMID: 22133770 DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Alemtuzumab; Rituximab

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived

Limitations and Caveats

A limitation of this trial is the small number of subjects included

Results Point of Contact

• Title: Dr. David Gomez-Almaguer
• Organization: Hospital Universitario

hematohu@yahoo.com

5281-83488510

Study Officials

• David Gomez-Almaguer, M.D.

  Hospital Universitario Dr. Jose E. Gonzalez

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 1, 2017
• Results First Posted: February 1, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)