Cytodyn Inc (CYDY)

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ANNOUNCEMENT : CLINICAL TRIALS CYTODYN'S FOR GVHD DRUG TO BEGIN SOON

https://clinicaltrials.gov/ct2/show/NCT02737306?term=cytodyn&rank=2

Study of PRO 140 for Prophylaxis of Acute GVHD in Patients With AML or MDS Undergoing Allogeneic Stem-Cell Transplant. (GVHD)
This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2016 by CytoDyn, Inc.
Sponsor:
CytoDyn, Inc.
Collaborator:
Amarex Clinical Research
Information provided by (Responsible Party):
CytoDyn, Inc.
ClinicalTrials.gov Identifier:
NCT02737306
First received: March 29, 2016
Last updated: April 12, 2016
Last verified: April 2016
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GVHD prophylaxis treatment for prevention of acute GVHD in adult patients with AML or MDS undergoing allogeneic stem-cell transplantation.

Condition Intervention Phase
Graft vs Host Disease
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Drug: PRO 140
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease (GVHD) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT).

Resource links provided by NLM:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA
MedlinePlus related topics: Acute Myeloid Leukemia Leukemia Myelodysplastic Syndromes
Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Homologous Wasting Disease Myelodysplastic Syndromes Myeloid Leukemia
U.S. FDA Resources

Further study details as provided by CytoDyn, Inc.:

Primary Outcome Measures:
Incidence of Grade II , Grade III or Grade IV acute GVHD [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
Incidence of severe and life-threatening (Grade III and Grade IV) acute GVHD [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
Incidence of organ-specific acute GVHD [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
Donor engraftment evaluated by T-cell in peripheral blood [ Time Frame: 365 days post-treatment (+/- 14 days) ] [ Designated as safety issue: No ]
Donor engraftment evaluated by myeloid chimerism in peripheral blood [ Time Frame: 365 days post-treatment (+/- 14 days) ] [ Designated as safety issue: No ]
Neutrophil count recovery [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: No ]
Platelet count recovery [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: No ]
Changes in ECOG performance score [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: No ]
GVHD-free survival (GFS) [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale). [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator-evaluation of injection site reactions. [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
Frequency of treatment emergent adverse events and serious adverse events [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: Yes ]
AML or MDS relapse rate [ Time Frame: 100 Days post treatment ] [ Designated as safety issue: No ]
Changes and shifts in laboratory measurements over time [ Time Frame: 365 days post-treatment (+/- 14 days) ] [ Designated as safety issue: Yes ]
Changes in Electrocardiogram (ECG) parameters over time [ Time Frame: 365 days post-treatment (+/- 14 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRO 140
30 subjects
Drug: PRO 140
Two 1 mL injections, 175mg/ml each, of PRO 140 to opposite sides of the abdomen.
Other Name: Humanized monoclonal antibody to CCR5
Placebo Comparator: Placebo
30 subjects.
Drug: Placebo
Two 1 mL injections of the Placebo to opposite sides of the abdomen.
Other Name: Placebo Comparator

Detailed Description:
In this study, 60 subjects will be randomized to receive either PRO 140 or placebo in a 1:1 ratio (i.e. 30 subjects per arm). PRO 140 or placebo will be administered as a 350 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for 30 days (at Week 1, Week 2, Week 3 and Week 4) after which it will be administered every two weeks for up to 100±7 days (at Week 6, Week 8, Week 10, Week 12 and Week 14). Subjects will return to clinic for two Follow-up visits at 2 weeks after the last treatment visit, and one year after the first treatment visit.
Eligibility

Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Patients diagnosed with AML or MDS per below:
Patients with a history of histologically or pathologically confirmed diagnosis of AML and < 5% blasts in the peripheral blood or bone marrow (per bone marrow aspiration and/or biopsy within 6 weeks prior to screening) scheduled to undergo allogeneic stem cell transplantation
Patients with a histologically or pathologically confirmed diagnosis of MDS with < 10% blasts in the bone marrow (per bone marrow aspiration and/or biopsy within 6 weeks prior to screening) scheduled to undergo allogeneic stem-cell transplantation
Eastern Cooperative oncology Group (ECOG) performance status score ≤ 2
Patients must have normal organ function as defined below:
If undergoing myeloablative allogeneic HCT:
Males and females, age ≥18 and ≤ 65 years of age
Total bilirubin ≤ 2 mg/dL (except in patients with Gilbert's Syndrome)
Aspartate Transaminase (AST) / Alanine Transaminase (ALT) ≤ 3 times institutional upper limit of normal (except in patients with leukemic infiltration of liver)
Serum creatinine ≤ 2 mg/dL and creatinine clearance ≥ 60 ml/hr
Diffusing capacity of the lung for carbon monoxide (DLCO) > 50% predicted with no symptomatic pulmonary disease
Cardiac ejection fraction ≥ 50%. If between 40-49% a cardiology consult is required
Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the PI
If undergoing non-myeloablative allogeneic HCT:
Males and females, age ≥18 and ≤ 75 years of age
Total bilirubin ≤ 2 mg/dL (except in patients with Gilbert's Syndrome)
AST/ALT ≤ 3 times institutional upper limit of normal (except in patients with leukemic infiltration of liver)
Serum creatinine ≤ 2 mg/dL and creatinine clearance ≥ 40 ml/hr
DLCO ≥ 40% predicted with no symptomatic pulmonary disease. If DLCO is ≥35% and < 40% and the patient is asymptomatic, a pulmonary consult is required
Cardiac ejection fraction > 30%
Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the PI
Patients must have a reasonable expectation of ≥ 6 months survival
The donor-recipient Human Leukocyte Antigen (HLA) match criteria required for participation in this protocol are not research subjects in this study and they must meet criteria as National Marrow Donor Program (NMDP) donors. Procedures for selection of donors and stem cell dose will follow FDA Code of Federal Regulations requirements for Blood Products (21 CFR 640) and Human Cellular and Tissue Based Products (21 CFR 1271). The standard institutional practices for stem cell transplants also will be followed. The donors are:
HLA-Identical Sibling (6/6): Minimal typing necessary is serologic typing for class I (AB) and molecular typing for class II (DRB1)
Matched Unrelated Donor (8/8): Molecular identity at HLA A, B, C and DRB1 by high-resolution typing
Matched Related and Unrelated Donor (7/8): high-resolution molecular typing at the following loci is required: HLA A, B, C and DRB1
Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
Patients must understand and voluntarily sign an informed consent form
Exclusion Criteria:

Patients not expected to be available for follow-up for at least 114 days after transplant
Patients who have received prior allogeneic stem cell-transplantation
Patients who receive post-transplant high dose cyclophosphamide
Patients with active central nervous system (CNS) involvement by malignant cells
Patients receiving other investigational drugs for GVHD. Co-enrollment in other clinical trials that do not include experimental GVHD therapies is allowed
Prior use of any experimental or approved C-C chemokine receptor type 5 (CCR5) modulators including maraviroc and PRO 140
Patients with uncontrolled bacterial, viral or fungal infections including diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of transplant)
Currently active second malignancy other than non-melanoma skin cancers
Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
Patients who are HIV positive
Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
Subjects on chronic steroid therapy > 5 mg/day within 2 weeks of screening except for inhaled, nasal, or topical steroids
Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02737306

Contacts
Contact: Anand Balasubramanian, B. Pharm 301-956-2531 [e-mail]

Sponsors and Collaborators
CytoDyn, Inc.
Amarex Clinical Research
More Information

Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT02737306 History of Changes
Other Study ID Numbers: PRO 140_CD 03_GVHD
Study First Received: March 29, 2016
Last Updated: April 12, 2016
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by CytoDyn, Inc.:
Allogeneic Stem-Cell Transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Immune System Diseases
Leukemia
Neoplasms
Neoplasms by Histologic Type
Precancerous Conditions

ClinicalTrials.gov processed this record on April 14, 2016

https://clinicaltrials.gov/ct2/show/NCT02737306?term=cytodyn&rank=2