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A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of CYP-001 in Combination with Corticosteroids vs Corticosteroids Alone for the Treatment of High-Risk Acute Graft Versus Host Disease
Cancer Categories
Hematologic (Blood Cancers)
Karmanos Trial ID
2024-027
NCT ID
NCT05643638
Age Group
Adult
Scope
National
Phase
Phase II
Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
Phase II
Principal Investigator
Joseph
Uberti, M.D., Ph.D.
Oncology - Hematology, Oncology - Medical
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Objective:
Primary Objective:
The primary objective of this study is to assess efficacy of CYP-001 in subjects with HRaGvHD by Overall Response Rate (ORR) at Day 28.
Secondary Objectives:
To assess additional responses and long-term efficacy outcomes
To assess Overall Survival (OS)
To assess Event-Free survival (EFS)
To assess Non-Relapse Mortality (NRM)
To assess Failure Free Survival
To assess the incidence of Malignancy Relapse/Progression (MR)
To measure the incidence of chronic GvHD
To assess the cumulative steroid dose until Day 100
To evaluate changes in Subject Reported Outcomes
To evaluate the safety and tolerability of CYP-001 in subjects with SR-aGvHD
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
Undergone allogeneic hematopoietic stem cell transplant (HSCT)
Clinically diagnosed with acute GvHD requiring systemic therapy with corticosteroids.
HR-aGvHD must meet one of the following clinical features within 72 hours prior to randomization: (a) high-risk as per Refined Minnesota Criteria; OR (b) One of the following: (i) isolated stage 2 involvement of the lower GI tract; (ii) Stage 1 lower GI tract disease with skin involvement
Evidence of myeloid engraftment post allogeneic HSCT
Life expectancy of at least one month
Exclusion Criteria:
Received any systemic treatment for aGvHD other than corticosteroids +/- calcineurin inhibitors
Chronic GvHD or overlap syndrome with both acute and chronic features of GvHD
Relapsed primary malignancy since
received more than one allogeneic HSCT
Clinically significant respiratory, renal or cardiac disease
Cholestatic disorders or sinusoidal obstructive syndrome/veno-occlusive disease of the liver
Any active uncontrolled infection requiring treatment and likely to impact on the ability of the subject to participate in the trial.
Known infection with CMV, EBV, HHV-6, HBV, HCV, HIV or Tuberculosis. If the treatment for CMV, EBV, HHV-6, HBV, HCV has commenced the subject is eligible.
Known sensitivity to dimethylsulfoxide (DMSO) or any other component of CYP-001.
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Hodgkin Lymphoma; Lymphoid Leukemia; Non-Hodgkin Lymphoma
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Cellular Therapy, Hormonal Therapy
Drugs
CYP-001; Placebo
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