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CD24Fc for the Prevention of Acute GVHD Following Myeloablative HSCT (CATHY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04095858
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
OncoImmune, Inc.

Brief Summary:
The study is designed as a randomized, placebo-controlled, double blind, multicenter, phase III trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: CD24Fc vs placebo with the standard GVHD prophylaxis of tacrolimus / methotrexate.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Acute Graft Versus Host Disease Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Drug: CD24Fc Drug: Placebo Drug: Methotrexate Drug: Tacrolimus Phase 3

Detailed Description:
The study is designed as a randomized, placebo-controlled, double blind, multicenter, phase III trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: CD24Fc/tacrolimus / methotrexate (CD24Fc/Tac/MTX) versus placebo/tacrolimus / methotrexate (placebo/Tac/MTX) in the setting of myeloablative conditioning (MAC), matched unrelated donor (MUD) allogeneic hematopoietic stem cell transplantation in patients with acute leukemia (AML/ALL) or myelodysplastic syndrome (MDS). The study agent, CD24Fc, will be administered through IV infusion on days -1, 14, and 28 at the dose of 480mg, 240 mg and 240mg, respectively. The placebo will be 100 ml normal saline IV solution.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Multi-center, Phase III Study of CD24Fc for Prevention of Acute Graft-versus-host Disease Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2024


Arm Intervention/treatment
Experimental: CD24Fc Treatment
CD24Fc: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV [0.03mg/kg/day] or PO [0.045mg/kg/dose] dosing is permitted; Methotrexate: given intravenously at a dose of 15 mg/m2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m2/dose on days 3, 6, and 11 after HCT.
Drug: CD24Fc
IV infusion: 480 mg at Day -1, 240 mg at Day 14, 240 mg at Day 28.
Other Name: Human CD24 and human IgG Fc Fusion Protein

Drug: Methotrexate
IV, 15 mg/m2/dose at Day 1, then 10 mg/m2/dose at Day 3, 6, 11.
Other Name: Trexall

Drug: Tacrolimus
Begin on day -3. IV [0.03mg/kg/day] or PO [0.045mg/kg/dose] dosing is permitted
Other Names:
  • FK506
  • Prograf

Placebo Comparator: Placebo
Placebo (Saline solution): 100ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV [0.03mg/kg/day] or PO [0.045mg/kg/dose] dosing is permitted; Methotrexate: given intravenously at a dose of 15 mg/m2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m2/dose on days 3, 6, and 11 after HCT.
Drug: Placebo
IV infusion, 100 ml at Day -1, Day 14, and Day 28.
Other Name: Saline

Drug: Methotrexate
IV, 15 mg/m2/dose at Day 1, then 10 mg/m2/dose at Day 3, 6, 11.
Other Name: Trexall

Drug: Tacrolimus
Begin on day -3. IV [0.03mg/kg/day] or PO [0.045mg/kg/dose] dosing is permitted
Other Names:
  • FK506
  • Prograf




Primary Outcome Measures :
  1. 180 day grade III-IV acute GVHD free survival (AGFS) [ Time Frame: 180 days after HCT. ]
    This is a composite endpoint to determine the Grade III-IV acute GVHD free survival (AGFS) in 180 days after HCT. The onset day of Grade III-IV aGVHD, or death of any cause, which comes the first, will be counted as the event.


Secondary Outcome Measures :
  1. One year overall survival (OS) [ Time Frame: 1 year ]
    This is to assess the one year overall survival.

  2. One year disease free survival (DFS) [ Time Frame: 1 year ]
    This is to assess the one year disease (relapse) free survival.

  3. 180 day grade II-IV acute GVHD free survival (AGFS) [ Time Frame: 180 days ]
    This is a composite endpoint to determine the Grade II-IV acute GVHD free survival (AGFS) in 180 days after HCT. The onset day of Grade II-IV aGVHD, or death of any cause, which comes the first, will be counted as the event.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A prospective patient for allogeneic HCT for a malignant hematologic disorder (see 3 for eligible diagnoses).
  2. The donor and recipient must have an HLA-8/8 allelic match at the HLA-A, -B, -C, and - DRB1 loci. High-resolution typing is required for all alleles for unmatched donors. Only matched unrelated donors are acceptable for this trial.
  3. The following diagnoses are to be included:

    1. Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) in first or second remission. Remission is defined as the absence of blasts in the peripheral circulation at the time of enrollment, < 5% blasts in the bone marrow and absence of extramedullary disease including CNS involvement.
    2. Myelodysplastic syndrome (MDS) with intermediate or high-risk IPSS or equivalent IPSS-R score with < 10% blasts in the bone marrow.
  4. Males or non-pregnant, non-lactating females, ≥ 18 years of age. Note there is no defined upper age limited, so long as deemed appropriate candidate for myeloablative conditioning.
  5. Karnofsky Performance Status >70%, see Appendix A.
  6. Patients must have normal or near normal organ function as defined by their treating institutions BMT program clinical practice guidelines. In addition, for purposes of this protocol minimum organ function criteria within 30 days of beginning conditioning include:

    Eligibility According to Pre HCT Organ Function:

    1. Total bilirubin ≤2.5 mg% (unless from Gilbert's disease or disease-related);
    2. AST(SGOT)/ALT(SGPT) <5.0 X institutional upper limit of normal;
    3. Estimated or actual GFR >50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (GFR should be corrected for BSA);
    4. Pulmonary Function Tests* DLCO, FEV1, FVC > 50% DLCO should be corrected for hemoglobin;
    5. Ejection Fraction* >50%;
    6. Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) ≤ 5.

    Item d and e may be assessed up to 10 weeks prior to the start of conditioning therapy.

  7. Ability to understand and the willingness to sign a written informed consent document.
  8. Women of child bearing potential and men must agree to use contraception prior to study entry and through day 100 post HCT (hormonal or barrier method of birth control; abstinence). Should a woman become pregnant or suspect she is pregnant while she or her partner is on treatment in this study, she should inform her study physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study until day 100 post HCT.

Exclusion Criteria:

  1. Subjects may not have presence of active CNS disease or extramedullary disease.
  2. Prior cytotoxic chemotherapy within 21 days from the initiation of HCT conditioning (i.e. intensive induction / consolidation for AML). Note, certain low intensity treatments not intended to induce remission but rather stabilize disease are acceptable up to 24 hrs prior to initiation of HCT conditioning (i.e. Tyrosine Kinase Inhibitor, sorafenib).
  3. Cord blood and haploidentical donors are not eligible.
  4. HLA-mismatch at the HLA-A, -B, -C, and - DRB1 loci. Note, HLA-DQ mismatches are permissible.
  5. Pregnant and nursing mothers are excluded from this study. This is because the risk to the fetus is unknown.
  6. Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures.
  7. Uncontrolled infections. Patients still under therapy for presumed or proven infection are eligible provided there is clear evidence (radiologic, clinical and/or culture) that the infection is well controlled.
  8. Patients seropositive or PCR positive for the human immunodeficiency virus (HIV). Patients with evidence of Hepatitis B or Hepatitis C PCR positivity.
  9. Prior HCT (allograft or prior autograft).
  10. Use of T cell depletion either ex vivo or in vivo (i.e. ATG, alemtuzumab) is prohibited.
  11. Current or prior diagnosis of antecedent Myelofibrosis is excluded.

Information from the National Library of Medicine

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): NCT04095858


Contacts
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Contact: Pan Zheng, MD, PhD 2027516823 pzheng@oncoimmune.com

Locations
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United States, California
City of Hope Cancer Center
Duarte, California, United States, 91010
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Principal Investigator: Hongtao Liu, MD, PhD         
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Principal Investigator: Sherif S Farag, MD         
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Principal Investigator: Sunil Abhyankar, MD         
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Principal Investigator: Nancy Hardy, MD         
United States, Michigan
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Principal Investigator: John Magenau, MD         
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Principal Investigator: Joseph Uberti, MD         
United States, Ohio
Ohio State University James Cancer Center
Columbus, Ohio, United States, 43210
Principal Investigator: Samantha Jaglowski, MD         
United States, Pennsylvania
Penn State University Cancer Institute
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Hong Zheng, MD, PhD         
University of Pennsylvania Perelman Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Alison Loren, MD, MSCE         
Sponsors and Collaborators
OncoImmune, Inc.
Investigators
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Study Chair: John Magenau, MD University of Michigan Rogel Cancer Center
Study Chair: Pavan Reddy University of Michigan Rogel Cancer Center

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Responsible Party: OncoImmune, Inc.
ClinicalTrials.gov Identifier: NCT04095858    
Other Study ID Numbers: CD24Fc-005-CATHY
15-4789 ( Other Identifier: FDA Orphan Drug Designation )
FD-OOPD-006089 ( Other Grant/Funding Number: FDA Orphan Products Clinical Trial Grant )
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Graft vs Host Disease
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Methotrexate
Tacrolimus
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors