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Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00014755
Recruitment Status : Completed
First Posted : April 11, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Office of Rare Diseases (ORD)

Tracking Information
First Submitted Date  ICMJE April 10, 2001
First Posted Date  ICMJE April 11, 2001
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE December 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Sclerosis
Official Title  ICMJE Not Provided
Brief Summary

OBJECTIVES: I. Determine the toxicity of total-body irradiation, anti-thymocyte globulin, and cyclophosphamide followed by syngeneic or autologous peripheral blood stem cell (PBSC) transplantation in patients with multiple sclerosis.

II. Determine the disease response of patients treated with this regimen. III. Determine the safety and efficacy of filgrastim (G-CSF) for PBSC mobilization in this patient population.

Detailed Description

PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral prednisone on days 0-10. Beginning on day 1, patients undergoing autologous peripheral blood stem cell (PBSC) transplantation receive filgrastim (G-CSF) subcutaneously daily until leukapheresis is completed. Leukapheresis begins on approximately day 4 and continues until adequate CD34+ PBSC are collected.

PBSC are collected from syngeneic donors in a similar manner. Patients undergo total-body irradiation twice daily on days -5 and -4. Patients receive cyclophosphamide IV on days -3 and -2 and anti-thymocyte globulin IV on days -5, -3, -1, 1, 3, and 5. Patients undergo autologous or syngeneic PBSC transplantation on day 0. Following PBSC transplantation, patients receive oral prednisone on days 7-30 and G-CSF IV daily beginning on day 0 and continuing until blood counts recover.

Patients are followed at 30, 80, and 90 days, monthly for 6 months, and then at 1 and 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: anti-thymocyte globulin
  • Drug: cyclophosphamide
  • Drug: filgrastim
  • Drug: prednisone
  • Procedure: peripheral blood stem cell transplantation
  • Procedure: irradiation
Study Arms  ICMJE Not Provided
Publications * Bowen JD, Kraft GH, Wundes A, Guan Q, Maravilla KR, Gooley TA, McSweeney PA, Pavletic SZ, Openshaw H, Storb R, Wener M, McLaughlin BA, Henstorf GR, Nash RA. Autologous hematopoietic cell transplantation following high-dose immunosuppressive therapy for advanced multiple sclerosis: long-term results. Bone Marrow Transplant. 2012 Jul;47(7):946-51. doi: 10.1038/bmt.2011.208. Epub 2011 Nov 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
35
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of rapidly progressive multiple sclerosis (MS) by Proser criteria and at high risk for a fatal outcome or severe disability with one of the following:

  • Primary progressive disease
  • Relapsing/remitting disease with 2 or more attacks in 2 years
  • Secondary progressive disease

Extended disability status scale (EDSS) between 5.0 and 8.0 with deterioration in the EDSS of 1 or more points over the past year

More than 60 days since relapse of MS

No evidence of myelodysplasia

Sibling donor proven to be an identical twin by ABO typing, HLA typing, and VNTR analysis (for syngeneic transplantation)

--Prior/Concurrent Therapy--

Radiotherapy: No prior total-lymphoid irradiation

Other: No other concurrent investigational agents

--Patient Characteristics-- Hepatic: No hepatic impairment that would preclude high-dose immunosuppressive therapy

Renal: No renal impairment that would preclude high-dose immunosuppressive therapy

Cardiovascular: No cardiac impairment that would preclude high-dose immunosuppressive therapy

Pulmonary: No pulmonary impairment that would preclude high-dose immunosuppressive therapy

Other:

  • No neurologic impairment that would preclude high-dose immunosuppressive therapy
  • No active uncontrolled infection
  • No active malignancy
  • No other illness that would severely limit life expectancy
  • No medical or psychiatric conditions that would preclude study
  • No history of hypersensitivity to murine proteins or E. coli-derived proteins
  • No demonstrated lack of compliance with prior medical care
  • Able to undergo an MRI scan
  • HIV negative
  • Not pregnant or nursing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00014755
Other Study ID Numbers  ICMJE 199/15796
FHCRC-1164.00
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fred Hutchinson Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Richard Nash Fred Hutchinson Cancer Center
PRS Account Office of Rare Diseases (ORD)
Verification Date April 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP