Autologous Transplant Targeted Against Crohn's (ATTAC)
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ClinicalTrials.gov Identifier: NCT04154735 |
Recruitment Status :
Withdrawn
(Discontinued by Investigator)
First Posted : November 6, 2019
Last Update Posted : November 8, 2019
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Condition or disease | Intervention/treatment | Phase |
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Crohn's Disease | Drug: Fludarabine Drug: Cyclophosphamide Drug: Mesna Drug: Alemtuzumab Drug: G-CSF Drug: Rifaximin Drug: Tacrolimus | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Autologous Hematopoietic Stem Cell Transplant for Crohn's Disease |
Estimated Study Start Date : | November 2019 |
Estimated Primary Completion Date : | March 2023 |
Estimated Study Completion Date : | March 2024 |

Arm | Intervention/treatment |
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Experimental: Hematopoietic Stem Cell Transplantation
Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with fludarabine, cyclophosphamide, mesna, and alemtuzumab. Granulocyte-colony stimulating factor (G-CSF) will be administered post-transplant until engraftment. Rifaximin and tacrolimus will be administered for 6 and 12 months, respectively, beginning one day before the infusion of stem cells.
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Drug: Fludarabine
A chemotherapy medication commonly used in the treatment of leukemia and lymphoma Drug: Cyclophosphamide A medication used as chemotherapy and to suppress the immune system
Other Name: Cytoxan Drug: Mesna A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder
Other Name: Mesnex Drug: Alemtuzumab A protein that kills the immune cells that are thought to be causing Crohn's; it is commonly used in the treatment of leukemia and lymphoma
Other Names:
Drug: G-CSF A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
Other Names:
Drug: Rifaximin An antibiotic used to treat irritable bowel syndrome and relapsing C. difficile infection; it inhibits DNA-dependent RNA polymerase
Other Name: Xifaxan Drug: Tacrolimus A medication which suppresses the immune system and inhibits T-lymphocytes; commonly used to lower the risk of organ rejection following transplant
Other Names:
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- Treatment-related mortality [ Time Frame: 3 years ]Treatment-related mortality
- Overall survival [ Time Frame: 3 years ]Survival of participants
- Clinical remission [ Time Frame: 6 months, 1 year, 2 years, 3 years ]Change of Crohn's Disease Activity Index CDAI ≤ 150, Harvey-Bradshaw Index (HBI) ≤4, may be on immune suppressive drugs
- Complete remission [ Time Frame: 1 year, 2 years, 3 years ]Change of Clinical, endoscopic, and histologic remission on no immune modulating drugs
- Craig's Crohn's Severity Index [ Time Frame: 6 months, 1 year, 2 years, 3 years ]Improvement in the severity of Crohn's Disease according to the Craig's Crohn's Severity Index (CDAI)
- Endoscopic severity scales [ Time Frame: 6 months, 1 year, 2 years, 3 years ]Improvement on the Simple Endoscopic Score for Crohn's Disease (SES-CD)
- Histologic remission on colonoscopy with biopsy [ Time Frame: 6 months, 1 year, 2 years, 3 years ]No evidence of disease on biopsy
- Endoscopic remission [ Time Frame: 6 months, 1 year, 2 years, 3 years ]No evidence of disease on colonoscopy
- Drug-free clinical remission [ Time Frame: 1 year, 2 years, 3 years ]Crohn's Disease Activity Index (CDAI ≤ 150),Harvey Bradshaw Index HBI ≤4, no immune suppressive drugs
- Relapse-free survival [ Time Frame: 6 months, 1 year, 2 years, 3 years ]Relapse is defined as Crohn's Disease Activity Index CDAI >150, Harvey Bradshaw Index HBI >4, and restarting or increasing immune based medication(s)
- Stool markers [ Time Frame: 6 months, 1 year, 2 years, 3 years ]Improvement in fecal calprotectin and fecal lactoferrin
- Quality of life short form Survey (SF-36) [ Time Frame: 6 months, 1 year, 2 years, 3 years ]Improvement in quality of life, measured by 36-Item Short Form Survey (SF-36) The evaluation of the results was done by attributing scores to each question, which were then transformed into a scale ranging from 0 to 100, where 0 corresponds to the worst quality of life and 100 to the best.
- Inflammatory Bowel Disease Questionnaire [ Time Frame: 6 months, 1 year, 2 years, 3 years ]Improvement on the Inflammatory Bowel Disease Questionnaire (IBDQ) Total IBDQ score ranges from 32 to 224. A higher score indicates better quality of life.
- Crohn's Disease Endoscopic Index of Severity (CDEIS) [ Time Frame: 6 months, 1 year, 2 years, 3 years ]Improvement on the Crohn's Disease Endoscopic Index of Severity (CDEIS)

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Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 years and less than age 50 years at the time of pre-transplant evaluation
- Ability to give informed consent
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An established clinical diagnosis of severe Crohn's Disease* that has failed therapy with prednisone or budesonide (Entocort) and either a or b below:
- At least two anti-tumor necrosis factor (TNF) drugs (e.g., infliximab (Remicade), adalimumab (Humira), or certolizumab pegol (Cimzia))
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One anti-TNF drug as above and either vedolizumab (Entyvio) or ustekinumab (Stelara)
- Severe Crohn's Disease is defined as a CDAI (see Appendix A) of 250 to 400 or a Craig's Crohn's Severity Index (CCSI, see Appendix B) that is > 17.
Exclusion Criteria:
- Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment
- Prior history of malignancy (except localized basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix). 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, inability to pursue effective means of birth control, or failure to willingly accept or comprehend irreversible sterility as a side effect of therapy
- HIV positive
- Hepatitis B or C positive
- Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
- Untreated life-threatening cardiac arrhythmia on EKG or 24-hour holter or history of coronary artery disease or congestive heart failure
- Left ventricular ejection fraction (LVEF) <50%
- Forced vital capacity (FVC) <60% of predicted after bronchodilator therapy (if necessary) or diffusing capacity of the lungs for carbon monoxide (DLCO) hemoglobin corrected <60 % predicted
- Serum creatinine >2 mg/dl
- 24-hour urine creatinine clearance <90
- Liver transaminases >2x of normal limits, or bilirubin >2 mg/dl unless due to Crohn's Disease
- Major hematological abnormalities such as platelet count < 100,000/ul or absolute neutrophil count (ANC) < 1500/ul
- Failure to collect at least 2 x10^6 cluster of differentiation 34 (CD34+) cells/kg
- Any active infection
- Known hypersensitivity to mouse, rabbit, or E. coli derived proteins
- Short Bowel Syndrome defined as intestinal dysfunction with the presence of significant malabsorption of both macronutrients and micronutrients or when gastrointestinal function is inadequate to maintain nutrient and hydration status without intravenous or enteral supplementation.
- History of anorexia nervosa (serum albumin ≤ 20 g/L, body mass index ≤ 18)
- Patients presenting with intestinal perforation or toxic megacolon or a problem that will require urgent surgery. The presence of intestinal stomas, strictures, or fistulae does not exclude the patient from study.
- Unable or unwilling to stop using and/or smoking tobacco products
- Abnormal peripheral blood cytogenetics

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154735
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Richard Burt, MD | Northwestern University |
Responsible Party: | Richard Burt, MD, Division Chief, Immunotherapy and Autoimmune Diseases, Northwestern University |
ClinicalTrials.gov Identifier: | NCT04154735 |
Other Study ID Numbers: |
DIAD.ATTAC.2018 |
First Posted: | November 6, 2019 Key Record Dates |
Last Update Posted: | November 8, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Autologous Stem Cell Transplantation Hematopoietic Stem Cell Transplant |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Rifaximin Cyclophosphamide Fludarabine Alemtuzumab Tacrolimus Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Calcineurin Inhibitors Enzyme Inhibitors Antineoplastic Agents, Immunological Anti-Bacterial Agents Anti-Infective Agents Gastrointestinal Agents |