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Proteasome Inhibitor
Cyclophosphamide + Bortezomib + Sitagliptin for Bone Marrow Transplant Complications
Phase 1 & 2
Waitlist Available
Research Sponsored by Sherif S. Farag
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (i.e. up to 5 years)
Awards & highlights
Study Summary
This trial tests a drug combination to see if it's safe and can help people with a certain cancer live longer.
Who is the study for?
Adults with certain blood cancers like AML, ALL, or MDS in remission who can undergo a reduced-intensity stem cell transplant. They should have good organ function and performance status, no HIV, not be pregnant or nursing, and agree to contraception. Excludes those with recent heart attacks or other transplants, insulin-dependent diabetes, known drug allergies, active CNS leukemia.Check my eligibility
What is being tested?
The trial is testing high doses of Cyclophosphamide combined with Bortezomib and Sitagliptin to prevent GVHD after stem cell transplantation. It's an open-label study starting with dose determination (Phase I) followed by assessing effectiveness (Phase II).See study design
What are the potential side effects?
Possible side effects include immune system suppression leading to increased infection risk; potential damage to organs such as the heart or liver; gastrointestinal issues; allergic reactions; and possibly new onset diabetes due to Sitagliptin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (i.e. up to 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (i.e. up to 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative incidence of grade II-IV acute GVHD
Maximum tolerated dose
Proportion of patients alive and free of grade II-IV acute GVHD (graft-versus-host disease)
+1 moreSecondary outcome measures
Chronic graft-versus-host disease
Cumulative Incidence engraftment of neutrophils and platelets
Cumulative incidences of all grades of acute GvHD
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Sitagliptin + Bortezomib + CyclophosphamideExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
2005
Completed Phase 2
~1140
Sitagliptin
2011
Completed Phase 4
~10170
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Sherif S. FaragLead Sponsor
6 Previous Clinical Trials
113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a specific type of blood cancer like AML, ALL, MDS, t-MDS, or CMML.I am 18 years old or older.I am a man and agree to use contraception or abstain from sex.I am eligible for a less intense stem cell transplant.I am not pregnant, nursing, and willing to use birth control or abstain from sex.I have diabetes needing insulin, pancreatitis, or painful gallstones.I am mostly able to care for myself and carry out daily activities.I haven't been treated for another cancer within the last 3 years.I do not have recent heart attacks, severe heart conditions, or active brain leukemia.I am receiving a specific type of stem cell transplant from a donor.I am eligible for a less intense treatment preparation.I had a stem cell transplant within the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Sitagliptin + Bortezomib + Cyclophosphamide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently opportunities for patients to participate in this research?
"Clinicaltrials.gov data informs us that this experiment is no longer enrolling participants, as it was last updated on May 30th 2023. Although the trial has ended enrollment, there are 1722 other medical studies actively recruiting patients currently."
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