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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

Must not have

The participant has urinary outflow obstruction

The participant is having their second transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 27 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I have difficulty urinating due to a blockage.

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I am preparing for my second transplant.

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I am not pregnant or breastfeeding.

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My leukemia has returned after treatment.

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I am receiving a cord blood or T-cell depleted graft.

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I am currently taking medication to prevent T-cell related complications.

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I am currently being treated for an active or chronic infection.

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I have been diagnosed with mixed phenotype acute leukemia.

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My cancer is in remission but my blood counts haven't fully recovered.

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I am a fertile man and agree to use contraception for at least one year after my transplant.

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I am allergic to rabbit proteins or certain ingredients in Thymoglobulin®.

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My bone marrow has more than 10% immature cells.

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

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

Primary study objectives

Registration of 80 patients within twenty four months

Secondary study objectives

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%

Fatigue

38%

Decreased appetite

35%

Confusional state

31%

Tachycardia

31%

Diarrhoea

31%

Hypokalaemia

27%

Constipation

27%

Hypophosphataemia

27%

Back pain

23%

Dizziness

23%

B-cell lymphoma

23%

Tremor

23%

Platelet count decreased

23%

White blood cell count decreased

19%

Cough

19%

Agitation

19%

Hyponatraemia

19%

Neutropenia

19%

Tachypnoea

19%

Hypogammaglobulinaemia

19%

Oedema peripheral

15%

Hypomagnesaemia

15%

Thrombocytopenia

15%

Alanine aminotransferase increased

15%

Sinus tachycardia

15%

Chills

15%

Dyspnoea

15%

Dysphagia

12%

Aspartate aminotransferase increased

12%

Pain

12%

Myalgia

12%

Hypertension

12%

Hyperglycaemia

12%

Hypoxia

12%

Vomiting

12%

Abdominal pain

12%

Peripheral sensory neuropathy

12%

Arthralgia

12%

Covid-19

12%

Malaise

Dysuria

Muscular weakness

Blood creatinine increased

Hyperhidrosis

Acute myeloid leukaemia

Sepsis

Pancytopenia

Eye pain

Lymphocyte count decreased

Asthenia

Urinary tract infection

Somnolence

Encephalopathy

Insomnia

Oral candidiasis

Pneumonia

Gait disturbance

Aphasia

Pleural effusion

Depression

Embolism

Syncope

Respiratory failure

Febrile neutropenia

Covid-19 pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Axicabtagene Ciloleucel and Rituximab Combination

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

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: 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 / 17Eligibility criteria met