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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)
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1a. Incidence of adverse events
1b. Incidence of adverse events
Secondary outcome measures
Acute graft versus host disease (GvHD)
Bone marrow residual damage assessment
Chronic GVHD
+12 moreSide effects data
From 2019 Phase 2 trial • 77 Patients • NCT012515755%
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
Filgrastim
2000
Completed Phase 3
~3670
Total Marrow Irradiation
2014
Completed Phase 1
~20
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Cyclophosphamide
1995
Completed Phase 3
~3770
Tacrolimus
2011
Completed Phase 4
~4740
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,642 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,987 Total Patients Enrolled
Anthony S SteinPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently on any experimental treatments or undergoing chemotherapy or radiation.I have a health or mental condition that makes stem cell transplant unsafe for me.My AML is in the first or second complete remission.It has been at least 14 days since my last cancer treatment session.My kidney function is normal, based on creatinine levels.I have previously been treated with etoposide and cyclophosphamide.I do not have any uncontrolled illnesses or infections.I do not have any other active cancers.I am able to care for myself but may not be able to do active work.My AML is in the first or second complete remission.I have a perfect match donor for my treatment.My heart's pumping ability is good and my heart rhythm is normal.My bilirubin level is 1.5 mg/dL or lower, and I don't have Gilbert's disease.I have had a stem cell transplant before my condition came back.I haven't had chemotherapy or radiation in the last two weeks.I have had radiation therapy that prevents me from receiving TMLI.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (TMLI, cyclophosphamide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is this medical experiment accessible?
"To be considered for this clinical trial, prospective participants must have a diagnosis of leukemia and fall within the age range between 16 to 60 years old. At present, 18 patients are sought after by medical professionals running the study."
Answered by AI
Could you provide a summary of any other research conducted in regards to Allogeneic Hematopoietic Stem Cell Transplantation?
"Currently, there are 993 active medical studies researching Allogeneic Hematopoietic Stem Cell Transplantation, of which 189 have progressed to the most advanced stage. Philadelphia is a major hub for such research but trials can be found in 30372 locations around the world."
Answered by AI
Has the Food and Drug Administration certified Allogeneic Hematopoietic Stem Cell Transplantation as a safe medical remedy?
"With limited data available on both efficacy and safety, Allogeneic Hematopoietic Stem Cell Transplantation received a score of 1."
Answered by AI
Is registration for this clinical trial still open to new participants?
"Affirmative. According to clinicaltrials.gov, this trial is still recruiting individuals - it was first posted on March 19th 2018 and most recently updated June 8th 2022. Only 18 volunteers are required from one site for the study."
Answered by AI
Does this medical experiment accommodate those aged 55 and up?
"For those meeting the criteria, this trial is open to participants from 16-60 years of age. There are currently 784 studies available for minors and 1983 trials accessible for seniors."
Answered by AI
What is the aggregate number of participants in this clinical experiment?
"Affirmative. Information hosted on clinicaltrials.gov verifies that this medical trial, which began recruiting patients in March 2018, is still actively seeking participants. It requires 18 people across a single centre to complete the study."
Answered by AI
What are the primary ailments Allogeneic Hematopoietic Stem Cell Transplantation is utilized to treat?
"Allogeneic Hematopoietic Stem Cell Transplantation is traditionally thought of as a leukemia treatment. However, it can also be applied to other situations such as the mobilization of hematopoietic stem cells therapy and for certain infections or lung cancers."
Answered by AI
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