Immune Ablation and Stem Cell Support for Crohn's Disease

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00179842
First received: September 10, 2005
Last updated: January 27, 2009
Last verified: January 2009

September 10, 2005
January 27, 2009
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To investigate the safety and efficacy of treating severe CD with high dose cyclophosphamide and antithymocyte globulin rescued with T cell depleted autologous stem cells. Data will be used to evaluate the efficiency of a future phase III protocol. [ Time Frame: Minimum of 2 years ] [ Designated as safety issue: Yes ]
To investigate the safety and efficacy of treating severe CD with high dose cyclophosphamide and antithymocyte globulin rescued with T cell depleted autologous stem cells. Data will be used to evaluate the efficiency of a future phase III protocol.
Complete list of historical versions of study NCT00179842 on ClinicalTrials.gov Archive Site
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Immune Ablation and Stem Cell Support for Crohn's Disease
Immune Ablation and Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease

The investigators anticipate that this study will also form the basis to clarify further the role of the immune system in Crohn's disease.

This study is designed to ablate an aberrant immune system and then, similar to the use of marrow transplants for immunodeficient patients, reconstitute a new immune system with lymphocyte depleted stem cells. Subsequent disease activity will be followed by (1) Crohn's disease activity index (CDAI), (2) quality of life instrument (IBDQ), (3) type and amount of therapy for CD, and (4) flow cytometry of peripheral blood lymphocyte subsets. In addition, the subjects will undergo periodic absorption function testing, to assess small intestinal function. We anticipate that this study will also form the basis to clarify further the role of the immune system in Crohn's disease.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn Disease
Procedure: Stem Cell Transplant
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
25
December 2008
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Inclusion Criteria:

  • Less than physiologic age 60 at time of pretransplant evaluation.
  • An established clinical diagnosis of severe CD that has failed therapy with prednisone, azathioprine, 5 ASA products and metronidazole, and has failed to have a sustained decrement of 70 points in the CDAI after one course of anti-TNF alpha, Infliximad. The patient is being considered for therapy with cyclosporin A (CSA) or surgical resection. The CDAI (appendix A) is 250-400.
  • Pre-study peripheral blood counts must include a platelet count greater than 100,000/ul and an absolute neutrophil count greater than 1500/ul.
  • Stem cell harvest greater than 1.4 x 106 CD34 cells/kg after CD34+ selection (to continue to transplant.)

Exclusion Criteria:

  • HIV positive
  • History of coronary artery disease, or congestive heart failure.
  • Uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy
  • Prior history of malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as head and neck cancer, or stage I breast cancer will be considered on an individual basis.
  • Positive pregnancy test, lactation, inability or unwillingness to pursue effective means of birth control, failure to accept or comprehend irreversible sterility as a side effect of therapy.
  • Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
  • FEV I/FVC < 50% of predicted, DLCO < 50% of predicted.
  • Resting LVEF < 40%
  • Bilirubin > 2.0 mg/dl, transferase (AST) > 2x upper limit of normal, unless the abnormalities are secondary to Crohn's disease.
  • Serum creatinine > 2.0 mg/dl.
  • Platelet count less than 100,000/ul, ANC less than 1500/ul.
  • Patients presenting with intestinal perforation or toxic megacolon, or a suppurative problem that will require urgent surgery. In addition, the patient may not have any active infection. The presence of intestinal stomas does not exclude the patient from study.
Both
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179842
BMT 1202
No
Dr. Morris Kletzel, Children's Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
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Principal Investigator: Morris Kletzel, M.D. Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
January 2009

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