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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
Must not have
Active central nervous system (CNS) disease
Concurrent treatment with any other approved or investigational anti-leukemia agent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 200 days post-transplant
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active brain or spinal cord condition.
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I am not currently receiving any other leukemia treatments.
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I am 18 years or older and receiving treatment at Seattle Children's Hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 200 days post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 200 days post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of disease progression
Rate of hematopoietic cell transplantation (HCT) failure

Side effects data

From 2010 Phase 2 trial • 21 Patients • NCT00060424
48%
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (FLAG-Ida, TBI, HCT, GVHD prophylaxis)Experimental Treatment15 Interventions
See detailed description.
Group II: Arm I (CLAG-M, TBI, HCT, GVHD prophylaxis)Experimental Treatment16 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Biospecimen Collection
2004
Completed Phase 3
~2030
Echocardiography
2013
Completed Phase 4
~11580
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Mycophenolate Sodium
2017
Completed Phase 4
~40
Mitoxantrone
2008
Completed Phase 3
~1550
Fludarabine
2012
Completed Phase 4
~1860
Idarubicin
2014
Completed Phase 4
~4380
Cyclophosphamide
2010
Completed Phase 4
~2310
Cytarabine
2016
Completed Phase 3
~3330
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Total-Body Irradiation
1997
Completed Phase 3
~1180
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Cladribine
2014
Completed Phase 4
~4650
Cyclosporine
1997
Completed Phase 3
~1820
Filgrastim
2000
Completed Phase 3
~3690

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor
571 Previous Clinical Trials
1,340,851 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,997 Total Patients Enrolled
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
147,861 Total Patients Enrolled
Filippo MilanoPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
6 Previous Clinical Trials
390 Total Patients Enrolled

Media Library

Cladribine (Antimetabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04375631 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Arm I (CLAG-M, TBI, HCT, GVHD prophylaxis), Arm II (FLAG-Ida, TBI, HCT, GVHD prophylaxis)
Acute Myeloid Leukemia Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT04375631 — Phase 1
Cladribine (Antimetabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04375631 — Phase 1
~24 spots leftby Dec 2025
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