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Radiation Therapy

peripheral blood stem cell transplantation for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Sumithira Vasu, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from start of conditioning to relapse, progression, death, initiation of non-protocol therapy, loss to follow up or end of study, whichever comes first, assessed at 1 year
Awards & highlights

Study Summary

This trial is testing a new, less intense form of radiation to see if it is effective and safe for patients with blood cancers who are ineligible for the current, more intense treatment.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Acute Promyelocytic Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndromes (MDS)
  • Adult Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of grade II/III organ toxicity, defined by the Bearman Regimen-Related Toxicities Scale
TRM, defined as death occurring in a patient from causes other than disease relapse
Secondary outcome measures
Cumulative incidence of grade II organ toxicity
Donor chimerism
Immune reconstitution
+9 more

Side effects data

From 2008 Phase 2 trial • 42 Patients • NCT00001566
38%
Fatigue
31%
Eosinophilia
29%
Fever
29%
Nausea
26%
Nasal congestion
26%
Headache
24%
Elevated SGPT (serum glutamic pyruvic transaminase)
24%
Vomiting
19%
Proteinuria
19%
Diarrhea
19%
Elevated SGOT(serum glutamic oxaloacetic transaminase)
17%
Chills
17%
Injection reaction
17%
Alkaline phosphate elevated
17%
Hematuria
17%
Thrombocytopenia
14%
Anemia
14%
Weight gain
12%
Neutropenia
12%
Cough
12%
Malaise
10%
Flu-like symptoms
10%
Dry skin
10%
Elevated D bili
10%
Hypotension
10%
Rash
7%
Decreased appetite
7%
Pruritis
7%
Elevated total bilirubin
7%
Intermittent pain in shaft of R tibia
7%
Myalgia
7%
Congestion
7%
flu symptoms
7%
Back pain
7%
Insomnia
7%
Hyperglycemia
7%
Intermittent H/A (headache)
7%
Low albumin
7%
Stomach ache
7%
Upset stomach
7%
Sore throat
7%
Stomach pain
7%
URI (upper respiratory infection)
7%
Weight loss
5%
Erythema
5%
Stye (L) lower corner eye
5%
Emesis
5%
Stuffy nose
5%
Lower back soreness
5%
Cold
5%
Dizziness
5%
AST (SGOT)
5%
Flush, facial
5%
Abdominal pain
5%
Dry lips
5%
Elevated magnesium
5%
Constipation
5%
Anxiety
5%
Hypothyroid
5%
Nausea/vomiting
5%
Elevated glucose
5%
Lips numb
5%
Flushing
5%
Loose stool
5%
Leg pain
5%
Joint pain
5%
Numbness in feet and hands
5%
Decreased L leg flexibility
5%
Edema, facial
5%
Discoloration skin (L) hand
5%
Heartburn
2%
Fever blister
2%
Platelets
2%
Itching
2%
Flushed skin
2%
Lethargic
2%
Ptosis
2%
Dizzy
2%
Pain R foot
2%
Gas pains
2%
Gas build-up
2%
Swell tongue
2%
L anterior chest pain
2%
Rash, arm/chs
2%
Sweating
2%
Cough nonproductive
2%
Itchy L. leg
2%
Nose congestion
2%
Patchy dry skin/itch trunk
2%
Swell ankle
2%
Leukocytes
2%
Pain
2%
Foot drop
2%
Runny nose
2%
Perior edema
2%
Left chest pressure
2%
Pain injection site
2%
Stiff neck
2%
Fever (by touch)
2%
Fever-low grade (by touch)
2%
Skin peeling
2%
Itching/injection site
2%
Quad muscle soreness
2%
Petechiae
2%
Abdominal discomfort
2%
Neutrophils
2%
Bilateral flank pain
2%
Eye pain
2%
Eyes watery
2%
Flatulence
2%
DVT (deep vein thrombosis)
2%
Acne (rash) on chest
2%
Anorexia
2%
Throat pain
2%
Vascular
2%
Decreased uric acid
2%
Drainage on foot
2%
Elevated BUN
2%
ALT (SGPT)
2%
Bitter taste in mouth
2%
Induration injection site
2%
Intermittent insomnia
2%
Elevated LFT's (liver function tests)
2%
Flush cheeks
2%
Skin rash
2%
Ear pain/infection
2%
Ulceration L heel
2%
Hemorrhage
2%
Elevated creatin
2%
CPK (Creatine phosphokinase)
2%
Chest tightness
2%
Decreased urine output (o/p)
2%
Acid reflux
2%
Eye swollen
2%
Impetigo
2%
INC SGPT (serum glutamic pyruvic transaminase)
2%
Intermittent cramping legs
2%
Rash with macules/papules
2%
Achiness
2%
Anxiety symptoms
2%
Decreased flexibility swelling left leg
2%
Glucosuria
2%
Hemoglobin
2%
Abdominal pain or cramping
2%
Cough (mild, intermittent)
2%
Gum line bump (L. upper)
2%
Hypoglycemia
2%
Indigestion
2%
Bad taste in mouth
2%
Cough (dry)
2%
Cranky
2%
Dry cough
2%
Elevated creatinine
2%
Low potassium
2%
Achy
2%
Generalized pain
2%
Hyponatremia
2%
Bruise
2%
Chelitis
2%
Double vision
2%
Dry heaves
2%
Dry scaly peeling skin
2%
Dry scaly skin
2%
Flushed
2%
Injection sclera
2%
Elevated creat
2%
Fever (by touch-low grade)
2%
INC SGOT (serum glutamic oxaloacetic transaminase)
2%
Glands swoll
2%
Increase fatigue
2%
Loose stools
2%
Rash/redness (top of arm)
2%
Rhinorrhea
2%
Muscle aches
2%
Myalgia-bilateral thighs
2%
Occipital (mild pain)
2%
Otitis media
2%
Pain, legs
2%
Hemorrhage sclera
2%
Kidney stone
2%
Left ear ringing
2%
Nose bleed
2%
Restlessness
2%
Hot feeling
2%
Hyperbilirubin
2%
Hyperthyroid
2%
Induration
2%
Hypertension
2%
Inf IV site
2%
Intermittent fatigue
2%
Jaw pain
2%
Malleolus (pain)
2%
Muscle atrophy
2%
Rash, chest
2%
Swelling lip
2%
Elev phos
2%
Hypomagnesemia
2%
Itching (chest)
2%
Swelling-lower extremity
2%
Tachycardia
2%
Tiredness
2%
Weakness (L. leg)
2%
Irritable
2%
Itchy legs
2%
Loss of balance
2%
Low CO2
2%
Minor sore throat
2%
Prickling sensation
2%
Quad/muscle pain
2%
Rhinitis
2%
Shoulder pain
2%
Nasal drainage
2%
Night sweat
2%
Pretib edema
2%
Puffy face
2%
Scrape on face
2%
Soreness under ribs
2%
Pressure in chest with inhalation
2%
Stomach burning
2%
Elevated uric acid
2%
Soreness/achiness
2%
Ulceration (R) heel
2%
Weakness
2%
Pain R hip
2%
Skin sensation
2%
Scratch under left eye
2%
Itchy scratch under left eye
2%
Ears ringing
2%
Ears ringing and clogged
2%
Edema
2%
Edema media R mid-thigh
2%
Edema on foot
2%
Hives
2%
Pain tailbone
2%
Sore mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (OSMI, allogeneic transplant)Experimental Treatment9 Interventions
CONDITIONING REGIMEN: Patients undergo organ-sparing marrow irradiation BID on days -6 to -4 and receive cyclophosphamide IV over 1-2 hours every 24 hours on days -3 to -2. Patients with an unrelated donor also receive anti-thymocyte globulin every 24 hours on days -4 to -2. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 and continuing for at least 6 months and methotrexate IV on days 1, 3, 6, and 11. TRANSPLANT: Patients undergo allogeneic peripheral blood progenitor cell or bone marrow transplant on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
allogeneic hematopoietic stem cell transplantation
2005
Completed Phase 3
~890
cyclophosphamide
1994
Completed Phase 3
~8140
methotrexate
1997
Completed Phase 3
~9960
tacrolimus
2004
Completed Phase 4
~3750
radiation therapy
1994
Completed Phase 3
~13390
allogeneic bone marrow transplantation
2005
Completed Phase 3
~5000
anti-thymocyte globulin
2005
Completed Phase 3
~1000
peripheral blood stem cell transplantation
1997
Completed Phase 3
~4330

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,134 Total Patients Enrolled
Sumithira VasuLead Sponsor
5 Previous Clinical Trials
89 Total Patients Enrolled
Sumithira Vasu, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
36 Total Patients Enrolled

Frequently Asked Questions

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

Who meets the requirements to become a participant in this research endeavor?

"Patients must meet certain criteria to be eligible for this trial, including adult acute myeloid leukemia with del(5q) and falling between the ages of 18-75. About 33 individuals will have their admission accepted."

Answered by AI

Could you inform me if this experiment is currently enrolling participants?

"At this time, no more participants are being admitted for this clinical trial. It was initially posted on July 27th 2015 and its information was last updated October 7th 2022. For those looking to find other studies, there are currently 3951 trials actively recruiting patients with adult acute myeloid leukemia with del(5q) and 1053 investigations into peripheral blood stem cell transplantation which have openings available."

Answered by AI

Is the age requirement for this research limited to those below 25 years of age?

"The parameters for participation in this clinical trial specify that patients must be aged between 18 and 75. On the other hand, there are 1334 studies available to people under the age of consent and 3932 research projects targeting those above 65 years old."

Answered by AI

How many participants are actively engaged in this research endeavor?

"This experiment is no longer accepting participants, with the original posting occurring on July 27th 2015 and its final update coming from October 7th 2022. However, 3951 trials are currently open for patients diagnosed with adult acute myeloid leukemia with del(5q) while 1053 medical studies regarding peripheral blood stem cell transplantation remain active."

Answered by AI

What other experiments have looked at the effects of peripheral blood stem cell transplantation?

"At present, 1053 clinical studies are assessing the efficacy of peripheral blood stem cell transplantation. Of those active trials, 206 have progressed to Phase 3 testing. While most research is occurring in Philadelphia, Pennsylvania there are 30458 locations running similar experiments."

Answered by AI

What health conditions are typically treated with peripheral blood stem cell transplantation?

"Notably, peripheral blood stem cell transplantation is used to treat small cell lung cancer (sclc) but can also be utilized in the management of dermatitis, atopic conditions, multiple sclerosis, leukemia and myelocytic acute."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies
Sumithira Vasu 2015. "Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02122081.
~3 spots leftby Apr 2025
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