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Alkylating agents

Low-Dose Cyclophosphamide for Graft-versus-Host Disease

Phase 1 & 2
Recruiting
Led By Christopher G Kanakry, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 50 years or age 18-49 years and meeting specific criteria
Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether a lower dose of a drug called cyclophosphamide is helpful for people who undergo blood stem cell transplants.

Who is the study for?
Adults over 18 with certain blood cancers eligible for a stem cell transplant from a related donor can join. Excluded are those with active non-blood cancer, severe allergies to similar drugs, uncontrolled illnesses, breastfeeding women, or anyone on other experimental treatments.Check my eligibility
What is being tested?
The trial is testing if lower doses of cyclophosphamide after stem cell transplants work better for preventing graft-versus-host disease. It includes other medications and procedures like imaging scans, heart and lung tests, and follow-ups for up to five years.See study design
What are the potential side effects?
Possible side effects include reactions to the drug infusion such as nausea or fever; organ inflammation; low blood counts leading to infection risk; mouth sores; and potential damage to bladder tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years or older, or I am 18-49 years old and meet specific criteria.
Select...
I have a blood cancer that requires a stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Determine the lowest effective dose of PTCy in combination with sirolimus and mycophenolate mofetil as GVHD prophylaxis after reduced intensity conditioning and PBSCT, as assessed by primary graft failure AND Grade III-IV acute GVHD as ...
Phase II: Evaluate the efficacy of PTCy, at the lowest dose determined for each HLA-matching arm from phase I, as assessed by 1-year GVHD-free relapse-free survival (GRFS) rate.
Secondary outcome measures
Describe and characterize cytokine release syndrome (CRS) (Phase I and II)
Estimate incidence progression/relapse at one year (Phase II only)
Estimate non-relapse mortality at one year (Phase II only)
+6 more

Side effects data

From 2020 Phase 2 trial • 57 Patients • NCT02440464
14%
Pyrexia
14%
Febrile neutropenia
10%
Pericarditis
10%
Graft versus host disease
5%
Acute kidney injury
5%
Atrial tachycardia
5%
Clostridium difficile infection
5%
Osteomyelitis
5%
Upper respiratory tract infection
5%
Vision blurred
5%
Pneumonia
5%
Myalgia
5%
Chest pain
5%
Gastroenteritis
5%
Superior vena cava syndrome
5%
Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixazomib Maintenance
Placebo
Enrolled Not Randomized

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: Phase II Efficacy (Matched HCT)Experimental Treatment9 Interventions
PTCy at shortest duration, safe dose (from Phase I)
Group II: Phase II Efficacy (Haplo HCT)Experimental Treatment9 Interventions
PTCy at shortest duration, safe dose (from Phase I)
Group III: Phase I Pilot for Comparative Data (Matched HCT)Experimental Treatment9 Interventions
Standard PTCy 50 mg/kg/day on days +3 and +4
Group IV: Phase I Pilot for Comparative Data (Haplo HCT)Experimental Treatment9 Interventions
Standard PTCy 50 mg/kgday on days +3 and +4
Group V: Phase I Dose De-escalation (Matched HCT)Experimental Treatment9 Interventions
PTCy at de-escalating doses to assess for safety and determine Phase II dose
Group VI: Phase I Dose De-escalation (Haplo HCT)Experimental Treatment9 Interventions
PTCy at de-escalating doses to assess for safety and determine Phase II dose
Group VII: Donors (Haplo HCT)Active Control1 Intervention
Research on collected samples
Group VIII: Donors (Matched HCT)Active Control1 Intervention
Research on collected samples
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Filgrastim
2000
Completed Phase 3
~3670
Allogeneic HSCT
2015
Completed Phase 2
~60
Mesna
2003
Completed Phase 2
~1380
Fludarabine
2012
Completed Phase 3
~1100
Melphalan
2008
Completed Phase 3
~1500
Sirolimus
2013
Completed Phase 4
~2750
Total Body Irradiation (TBI)
2016
Completed Phase 3
~1220

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,155 Total Patients Enrolled
Christopher G Kanakry, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
1,226 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05436418 — Phase 1 & 2
Bone Marrow Transplant Research Study Groups: Phase I Dose De-escalation (Matched HCT), Phase I Pilot for Comparative Data (Matched HCT), Phase II Efficacy (Haplo HCT), Phase II Efficacy (Matched HCT), Donors (Haplo HCT), Donors (Matched HCT), Phase I Dose De-escalation (Haplo HCT), Phase I Pilot for Comparative Data (Haplo HCT)
Bone Marrow Transplant Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05436418 — Phase 1 & 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05436418 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main intentions of this research project?

"This clinical trial, which will be closely monitored over the course of a year, seeks to find the lowest effective dose of PTCy in combination with sirolimus and mycophenolate mofetil as GVHD prophylaxis after reduced intensity conditioning and PBSCT. The primary goal is to assess for primary graft failure AND Grade III-IV acute GVHD. Secondary objectives include estimating rates of any chronic GVHD and moderate/severe chronic GVHD at one year, describing and characterizing cytokine release syndrome (CRS) incidence, frequency and severity as well as measuring symptomatic BK virus"

Answered by AI

What is the sample size of participants in this experiment?

"Affirmative. According to the information published on clinicaltrials.gov, this research is actively recruiting for participants and was initially posted on November 18th 2022 with a most recent update occurring on 23rd of the same month. There are 220 prospective patients that need to be recruited from one site of operation."

Answered by AI

Are there any vacant slots available to participate in this research?

"The study is recruiting, with initial postings on the 18th of November 2022 and recent edits made on the 23rd. This information can be found at clinicaltrials.gov."

Answered by AI
~160 spots leftby Jun 2027