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Antimetabolites
Chemotherapy + Stem Cell Transplant for Leukemia and Related Disorders
Phase 1
Recruiting
Led By Filippo Milano
Research Sponsored by Fred Hutchinson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A human leukocyte antigen (HLA)-matched or near-matched related or unrelated donor for collection of stimulated peripheral blood stem cells must be identified and readily available
Age 18-75 years with an Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) =< 5 for patients over 60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying how well total body irradiation works when given with CLAG-M chemotherapy reduced-intensity conditioning regimen before stem cell transplant in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia that has come back or does not respond to treatment.
Who is the study for?
Adults aged 18-75 with certain blood cancers (AML, MDS, CMML) that are resistant to treatment or have returned after treatment. They must have a related donor for stem cell transplant, be in good physical condition with no severe heart, liver or kidney issues and not pregnant. A suitable donor without strong immune reactions against the patient's cells is needed.Check my eligibility
What is being tested?
The trial tests two chemotherapy regimens (CLAG-M and FLAG-Ida) combined with low-dose total body irradiation before a stem cell transplant from a donor. The goal is to see how well this approach works for treating relapsed/refractory blood cancers by making space in bone marrow for new cells and potentially eliminating remaining cancer.See study design
What are the potential side effects?
Possible side effects include reactions to chemotherapy drugs like fatigue, nausea, hair loss; complications from radiation such as skin irritation; risks associated with stem cell transplants like infection risk increase due to weakened immunity and graft versus host disease where the donated cells attack the patient's own tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a donor match for a stem cell transplant.
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I am between 18-75 years old and have a low to moderate health risk for a cell transplant.
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My heart is strong and functions well, with no severe heart failure or uncontrolled irregular heartbeat.
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My donor is a family member who matches me closely in specific genetic markers.
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I am mostly independent and active, with a good performance status.
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My donor is a close match for my transplant, with only one minor difference.
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I have a donor match for a stem cell transplant.
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I have a donor who matches my HLA type for a stem cell transplant.
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My donor and I do not have a two-allele mismatch in our genetic makeup.
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My lung function is good and I don't need extra oxygen.
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My donor and I match for specific genetic markers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of disease progression
Rate of hematopoietic cell transplantation (HCT) failure
Secondary outcome measures
Disease response
Duration of remission
Incidence of adverse events
+2 moreSide effects data
From 2010 Phase 2 trial • 21 Patients • NCT0006042448%
Neutropenia
10%
Death following disease progression post transplant
10%
Thrombocytopenia
10%
Hyperbilirubinemia
10%
Hypoxia
5%
Typhlitis & Bowel Perforation
5%
Death following progression of GVHD
5%
Cardiac Arrhythmia and Seizure
5%
Death: Sepsis/Renal failure/ with history of GVHD
5%
Severe abnormal pain due to gut GVH
5%
Acute Pulmonary Embolism
5%
Perforated sigmoid diverticulitis
5%
Minimal hydronephosis
5%
Cholecystectomy
5%
Hypotension
5%
Increased creatinine
5%
Neurotoxicity
5%
Renal failure
5%
Tumor lysis syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (FLAG-Ida, TBI, HCT, GVHD prophylaxis)Experimental Treatment14 Interventions
See detailed description.
Group II: Arm I (CLAG-M, TBI, HCT, GVHD prophylaxis)Experimental Treatment10 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Mitoxantrone
2008
Completed Phase 3
~1540
Fludarabine
2012
Completed Phase 3
~1100
Idarubicin
2014
Completed Phase 4
~4330
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Echocardiography
2013
Completed Phase 4
~11670
Cyclophosphamide
1995
Completed Phase 3
~3770
Cytarabine
2016
Completed Phase 3
~3310
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Mycophenolate Sodium
2017
Completed Phase 4
~40
Total-Body Irradiation
1997
Completed Phase 3
~1180
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Cladribine
2014
Completed Phase 4
~4390
Cyclosporine
1997
Completed Phase 3
~1830
Filgrastim
2000
Completed Phase 3
~3670
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,275 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,734 Total Patients Enrolled
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,252 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a donor match for a stem cell transplant.I have an active brain or spinal cord condition.I am not currently receiving any other leukemia treatments.I am between 18-75 years old and have a low to moderate health risk for a cell transplant.My MDS or CMML did not respond to at least one standard treatment.I have an infection, but it is being treated or is under control.My donor is a family member who matches me closely in specific genetic markers.My heart is strong and functions well, with no severe heart failure or uncontrolled irregular heartbeat.I have been tested and my anti-donor antibodies are low enough for a transplant.I may have used hydroxyurea or received specific treatments for high white blood cell counts before starting the study.I am mostly independent and active, with a good performance status.I have had chemotherapy for MDS or AML and may have been sensitive to specific treatments.My AML has not responded well to standard treatments or is in relapse.My donor is a close match for my transplant, with only one minor difference.I have a donor match for a stem cell transplant.I have a donor who matches my HLA type for a stem cell transplant.My donor and I do not have a two-allele mismatch in our genetic makeup.My previous stem cell transplant failed between 3 to 6 months after the procedure.My lung function is good and I don't need extra oxygen.My donor and I match for specific genetic markers.My bilirubin levels are within normal range, or high due to specific conditions.I had a bone marrow transplant with low-dose radiation over 6 months ago.I have had chemotherapy for MDS or AML, possibly with mitoxantrone or cladribine.I am 18 or older and have a low to moderate risk score for transplant complications.I cannot have a donor with a positive crossmatch due to my immune response.I am 18 years or older and receiving treatment at Seattle Children's Hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (CLAG-M, TBI, HCT, GVHD prophylaxis)
- Group 2: Arm II (FLAG-Ida, TBI, HCT, GVHD prophylaxis)
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.
Has Hematopoietic Cell Transplantation been granted approval by the FDA?
"Hematopoietic Cell Transplantation is still in its early trial stages, making safety and efficacy data scarce; as a result, it received the lowest rating of 1."
Answered by AI
For what medical conditions is Hematopoietic Cell Transplantation typically prescribed?
"Hematopoietic Cell Transplantation can be utilized to combat transplant rejection, multiple sclerosis and lupus nephritis."
Answered by AI
What eligibility requirements must an individual meet in order to participate in this research?
"This medical trial requires 72 participants aged between 18 and 75 who suffer from myelodysplastic syndromes. In addition, the following criteria must be met: HCT-CI score =< 5, treatment history with a hypomethylating agent (HMA) or induction chemotherapy that failed to yield results, Karnofsky score >= 70; ECOG 0-1, cardiac function of left ventricular ejection fraction >= 45%, bilirubin levels below 2.5 x institutional upper limit of normal unless due to AML/Gilbert's Syndrome/hemolysis, pulmonary functionality with no O2 needs"
Answered by AI
Is there still availability for people to participate in this trial?
"Evidenced by clinicaltrials.gov, this research initiative is still actively seeking out participants. Initially posted on December 3rd 2020 and last updated on October 27th 2022, the study remains open for enrollment."
Answered by AI
Are there additional research initiatives exploring Hematopoietic Cell Transplantation?
"Currently, 1174 studies concerning Hematopoietic Cell Transplantation are in progress. Of those ongoing trials, 226 of them have reached Phase 3. Although Philadelphia, Pennsylvania is the main hub for research on this topic, 34959 medical centres across the globe are currently running tests related to it."
Answered by AI
Does this research have an age restriction, and if so, what is it?
"In order to be considered eligible for this trial, the minimum required age is 18 while the upper limit of enrollment is 75 years old."
Answered by AI
How many individuals have enrolled in this examination thus far?
"Affirmative. According to clinicaltrials.gov, this medical research project is recruiting participants at present; it was first posted on December 3rd 2020 and last updated October 27th 2022. The trial requires a total of 72 patients from one location."
Answered by AI
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