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Immunosuppressant

ATG + PTCy for Graft-versus-Host Disease Prophylaxis

Phase 2

Recruiting

Led By Irwin R Walker, MBBS

Research Sponsored by McMaster University

Eligibility Criteria Checklist

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

Must have

The participant meets the transplant centre's criteria for transplantation, using either myeloablative or reduced intensity conditioning

The participant is receiving their first transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 27 months

Awards & highlights

Study Summary

This trial is testing whether using a certain combination of drugs can prevent a specific complication from happening after a transplant.

Who is the study for?

This trial is for individuals aged ≥16 with acute myeloid leukemia in remission or myelodysplastic syndrome, planning their first stem cell transplant from a fully matched donor. They must be medically fit, have good performance status, and agree to use contraception post-transplant. Exclusions include pregnancy, breastfeeding, HIV positivity, certain prior cancers or treatments.Check my eligibility

What is being tested?

The study aims to compare the effectiveness of anti-thymocyte globulin (ATG) combined with cyclophosphamide versus ATG alone in preventing chronic graft-versus-host disease after stem cell transplantation in patients with specific blood disorders.See study design

What are the potential side effects?

Possible side effects may include allergic reactions to rabbit proteins found in ATG, such as fever and chills; cyclophosphamide can cause nausea, hair loss, mouth sores and increase infection risk due to lowered white blood cells.

Eligibility Criteria

Inclusion Criteria

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

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I meet the criteria for a bone marrow transplant at my treatment center.

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This is my first time receiving a transplant.

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I have a donor who matches my tissue type for a transplant.

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I have acute myeloid leukemia in remission or myelodysplastic syndrome.

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I am mostly able to care for myself and carry out daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Registration of 80 patients within twenty four months

Secondary outcome measures

CRFS

Complete data collection

Cost of study

+2 more

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401

88%

Pyrexia

65%

Neutrophil count decreased

62%

Nausea

58%

Hypotension

50%

Anaemia

46%

Headache

38%

Decreased appetite

38%

Fatigue

35%

Confusional state

31%

Hypokalaemia

31%

Diarrhoea

31%

Tachycardia

27%

Constipation

27%

Back pain

27%

Hypophosphataemia

23%

Dizziness

23%

Platelet count decreased

23%

Tremor

23%

B-cell lymphoma

23%

White blood cell count decreased

19%

Oedema peripheral

19%

Neutropenia

19%

Cough

19%

Hypogammaglobulinaemia

19%

Hyponatraemia

19%

Tachypnoea

19%

Agitation

15%

Alanine aminotransferase increased

15%

Thrombocytopenia

15%

Chills

15%

Dyspnoea

15%

Hypomagnesaemia

15%

Sinus tachycardia

15%

Dysphagia

12%

Hypertension

12%

Vomiting

12%

Abdominal pain

12%

Aspartate aminotransferase increased

12%

Pain

12%

Malaise

12%

Myalgia

12%

Hypoxia

12%

Arthralgia

12%

Hyperglycaemia

12%

Covid-19

12%

Peripheral sensory neuropathy

Hyperhidrosis

Aphasia

Pancytopenia

Muscular weakness

Pneumonia

Encephalopathy

Eye pain

Gait disturbance

Oral candidiasis

Urinary tract infection

Sepsis

Blood creatinine increased

Acute myeloid leukaemia

Insomnia

Somnolence

Dysuria

Asthenia

Lymphocyte count decreased

Pleural effusion

Covid-19 pneumonia

Respiratory failure

Febrile neutropenia

Embolism

Depression

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Axicabtagene Ciloleucel and Rituximab Combination

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ATG/PTCyExperimental Treatment2 Interventions

Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1); cyclophosphamide (Post Transplant Cyclophosphamide, PTCy) 50 mg/kg IV daily on days +3 and +4.

Group II: ATGActive Control1 Intervention

Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cell Therapy Transplant CanadaUNKNOWN

SanofiIndustry Sponsor

2,164 Previous Clinical Trials

3,514,900 Total Patients Enrolled

Ozmosis Research Inc.Industry Sponsor

20 Previous Clinical Trials

4,935 Total Patients Enrolled

Media Library

Anti-Thymocyte globulin (rabbit) (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04202835 — Phase 2

Anti-Thymocyte globulin (rabbit) (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04202835 — Phase 2

Acute Leukemia Research Study Groups: ATG/PTCy, ATG

Acute Leukemia Clinical Trial 2023: Anti-Thymocyte globulin (rabbit) Highlights & Side Effects. Trial Name: NCT04202835 — Phase 2

Frequently Asked Questions

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

Are there long-term repercussions to using Cyclophosphamide?

"Cyclophosphamide was given a 2 because, while there is data indicating that it is safe, none of the clinical trials conducted thus far have proven its efficacy."

Answered by AI

What is the existing body of research on Cyclophosphamide?

"City of Hope Comprehensive Cancer Center was the first to study cyclophosphamide in 1997 and, since then, 1192 completed trials. There are 876 studies still ongoing with a large number of these clinical trials based in London, Ontario."

Answered by AI

Could you tell me how many active research sites are in the United States for this trial?

"Patients can choose from 6 available clinical trial sites, which are located in London, Winnipeg, Hamilton, and a few other cities."

Answered by AI

Are there any restrictions for who can join this experiment?

"Up to 80 patients that have myelodysplasia and are between 16-70 years old can be enrolled in this study. Most importantly, potential participants must meet the following qualifications: First transplant recipient, Aged ≥16 and deemed medically fit by doctor's standards, Will receive blood progenitor cell graft ("HPC, Apheresis"), Has a related or unrelated donor who is fully MHC matched with the recipient at HLA-A, B , C and DRB1., ability to follow study procedures as well as schedule according to investigator's opinion."

Answered by AI

What are some common illnesses that doctors use Cyclophosphamide to manage?

"While most often used as part of an immunosuppressive treatment, cyclophosphamide can also be helpful for patients with conditions like multiple sclerosis, leukemia, myelocytic, acute, retinoblastoma."

Answered by AI

Does this research include young people within the age bracket of eighteen to thirty-nine years old?

"This particular trial is only open to patients aged 16-70. There are 468 other trials for people under 18 and 1222 for senior citizens above the age of 65."

Answered by AI

Are new patients being enrolled in this trial at present?

"That is accurate. The clinical trial, which was posted on October 13th 2020 and updated on August 30th 2021, is still recruiting patients. They are looking for 80 participants that will be gathered from 6 different sites."

Answered by AI

How many total individuals are included in this research project?

"Eighty patients that meet the requirements will be used in the study. The sponsor, Ozmosis Research Inc., has chosen London Health Sciences Centre and CancerCare Manitoba as two of their many trial sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ATG Plus PTCy vs ATG for CGVHD Prophylaxis

2020. "ATG Plus PTCy vs ATG for CGVHD Prophylaxis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04202835.

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