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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

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 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
5%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)

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
~2320
Filgrastim
2000
Completed Phase 3
~3690
Total Marrow Irradiation
2014
Completed Phase 1
~20
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Tacrolimus
2019
Completed Phase 4
~5510

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,519 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,982 Total Patients Enrolled
Anthony S SteinPrincipal InvestigatorCity of Hope Comprehensive Cancer Center

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03467386 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Treatment (TMLI, cyclophosphamide)
Acute Myeloid Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03467386 — Phase 1
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03467386 — Phase 1
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