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Alkylating agents

Bone Marrow Irradiation + Cyclophosphamide for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Anthony S Stein

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Serum creatinine of <= 1.3 mg/dL or creatinine clearance > 70 ml/min

Patients with acute myeloid leukemia (AML) evaluated within 30 days of the start of conditioning regimen and in first or second complete remission (CR)

Must not have

Uncontrolled illness including ongoing or active or poorly controlled infection

Receiving other investigational agents, concurrent biological, chemotherapy, or radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment (hematopoietic stem cell transplant [hct]) to grade 3-4 acute gvhd, chronic gvhd requiring systemic treatment, relapse, or death (from any cause), whichever occurs first, assessed p to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects of total bone marrow and lymphoid irradiation and how well it works with cyclophosphamide in treating patients with acute myeloid leukemia.

Who is the study for?

This trial is for adults with acute myeloid leukemia in first or second complete remission. Participants must have a matched sibling or unrelated donor for stem cell transplant, good heart and kidney function, and no recent chemotherapy or radiation. They should not be pregnant, agree to use contraception, and be able to give informed consent.

What is being tested?

The trial tests total marrow and lymphoid irradiation followed by a stem cell transplant from a donor, along with cyclophosphamide treatment. It aims to see how well this approach works compared to traditional whole-body radiation therapy in treating leukemia without harming other organs.

What are the potential side effects?

Possible side effects include damage to bone marrow resulting in low blood counts, risk of infections due to weakened immune system post-transplant, potential organ inflammation from radiation exposure, nausea from chemotherapy drugs like cyclophosphamide, and fertility issues.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function is normal, based on creatinine levels.

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My AML is in the first or second complete remission.

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I am able to care for myself but may not be able to do active work.

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My AML is in the first or second complete remission.

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I have a perfect match donor for my treatment.

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My heart's pumping ability is good and my heart rhythm is normal.

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My bilirubin level is 1.5 mg/dL or lower, and I don't have Gilbert's disease.

Exclusion Criteria

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

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I do not have any uncontrolled illnesses or infections.

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I am not currently on any experimental treatments or undergoing chemotherapy or radiation.

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I have a health or mental condition that makes stem cell transplant unsafe for me.

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I do not have any other active cancers.

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I have had a stem cell transplant before my condition came back.

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I haven't had chemotherapy or radiation in the last two weeks.

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I have had radiation therapy that prevents me from receiving TMLI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment (hematopoietic stem cell transplant [hct]) to grade 3-4 acute gvhd, chronic gvhd requiring systemic treatment, relapse, or death (from any cause), whichever occurs first, assessed p to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment (hematopoietic stem cell transplant [hct]) to grade 3-4 acute gvhd, chronic gvhd requiring systemic treatment, relapse, or death (from any cause), whichever occurs first, assessed p to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment (hematopoietic stem cell transplant [hct]) to grade 3-4 acute gvhd, chronic gvhd requiring systemic treatment, relapse, or death (from any cause), whichever occurs first, assessed p to 24 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

1a. Incidence of adverse events

1b. Incidence of adverse events

Secondary study objectives

Acute graft versus host disease (GvHD)

Chronic GVHD

GvHD-free/relapse-free survival (GRFS)

+8 more

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575

Hypoxia

Febrile neutropenia

Acute kidney injury

Blood bilirubin increased

Diarrhea

Creatinine increased

Sepsis

Hypotension

Left ventricular systolic dysfunction

Bronchopulmonary hemorrhage

Chronic kidney disease

Thromboembolic event

Lung infection

Atrial fibrillation

Atrial flutter

Hemolysis

Hemolytic uremic syndrome

Ejection fraction decreased

Encephalitis infection

Gastric hemorrhage

Gastritis

Heart failure

Mucositis oral

Multi-organ failure

Myalgia

Pleural effusion

Respiratory failure

Small intestine infection

Syncope

Treatment related secondary malignancy

Typhlitis

Fever

Paroxysmal atrial tachycardia

Ascites

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Fludarabine, Transplant, Immunosuppression)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (TMLI, cyclophosphamide)Experimental Treatment8 Interventions

Patients undergo TMLI BID on days -4 to 0, then undergo bone marrow or peripheral blood stem cell transplant on day 0. Patients receive cyclophosphamide IV over 2 hours on days 3 and 4, tacrolimus given by CIV on days 5-90, and filgrastim beginning on day 5 until ANC is at least 1,500/mm\^3 for 3 consecutive days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Filgrastim

2000

Completed Phase 3

~3690