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Alkylating agents

Cyclophosphamide for Graft-versus-Host Disease

Omaha, NE

Phase 2

Waitlist Available

Led By Vijaya R Bhatt, MBBS

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of a hematological malignancy or other serious hematological disorder that requires an allogeneic hematopoietic cell transplantation

Adults aged 60 years or older

Must not have

Planned use of high doses of cyclophosphamide as part of the conditioning regimen prior to allogeneic stem cell transplant

Diagnosis of myelofibrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of transplant to 1 year post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how well patients feel after a stem cell transplant when they receive different doses of a medication called cyclophosphamide to prevent complications.

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Who is the study for?

This trial is for individuals who have received an allogeneic hematopoietic stem cell transplant to treat various blood cancers and are at risk of developing graft-versus-host disease (GVHD). Specific eligibility criteria details were not provided.Check my eligibility

What is being tested?

The study compares the effects of standard versus reduced doses of post-transplant cyclophosphamide, along with a two-drug regimen for preventing GVHD, which includes Mycophenolate Mofetil (MMF) and Sirolimus.See study design

What are the potential side effects?

Potential side effects may include immune system suppression leading to increased infection risk, possible damage to organs such as the bladder or liver from Cyclophosphamide, gastrointestinal issues from MMF, and risks associated with Sirolimus like mouth sores or abnormal blood lipid levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a bone marrow transplant for my blood cancer or disorder.

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I am 60 years old or older.

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I am scheduled for a stem cell transplant with a matching donor.

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I am mostly independent and can care for myself.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I will receive high doses of cyclophosphamide before my stem cell transplant.

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I have been diagnosed with myelofibrosis.

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My heart's pumping ability is reduced.

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I have had one or more bone marrow transplants from a donor.

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My kidney function is reduced with a creatinine clearance below 40 mL/min.

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My donor is partially matched to me.

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I have liver cirrhosis or a severe liver condition affecting medication breakdown.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of transplant to 1 year post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of transplant to 1 year post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of transplant to 1 year post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Health-Related Quality of Life as Measured by FACT-BMT

Secondary study objectives

Change in Activities of Daily Living (ADL)

Change in Body Mass Index (BMI)

Change in Clock-in-the-Box Test

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Attenuated-dose post-transplant cyclophosphamide (PTCy) ArmExperimental Treatment3 Interventions

Participants will receive attenuated-dose post-transplant cyclophosphamide (PTCy) at 25 mg/kg on days +3 and +4 after allogeneic hematopoietic stem cell transplantation. This is in addition to sirolimus and mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis.

Group II: High-dose post-transplant cyclophosphamide (PTCy) Arm: Standard of CareActive Control3 Interventions

Participants will receive high-dose post-transplant cyclophosphamide (PTCy) at 50 mg/kg on days +3 and +4 after allogeneic hematopoietic stem cell transplantation. This is in addition to sirolimus and mycophenolate mofetil (MMF) for GVHD prophylaxis.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sirolimus

2013

Completed Phase 3

~3100

Mycophenolate Mofetil (MMF)

2000

Completed Phase 4

~740