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Alkylating Agent
Sorafenib + Chemotherapy for Acute Myeloid Leukemia
Phase 1 & 2
Waitlist Available
Led By Uday R Popat
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Human leukocyte antigen (HLA)-identical sibling or 8/8 matched unrelated donor available
Age between 18 and 70 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is studying the best dose of sorafenib to give with busulfan and fludarabine in treating patients with acute myeloid leukemia.
Who is the study for?
Adults aged 18-70 with recurrent or unresponsive acute myeloid leukemia, suitable for donor stem cell transplant. Must have a matched sibling or unrelated donor, normal organ function tests, and agree to contraception. Excludes those with certain heart conditions, bleeding disorders, other cancers within 3 years (except some skin/bladder cancers), major surgery within the last month, and inability to take oral medication.Check my eligibility
What is being tested?
The trial is testing the effectiveness of sorafenib combined with busulfan and fludarabine in patients undergoing stem cell transplants for acute myeloid leukemia that has returned or is treatment-resistant. It aims to find the best dose of sorafenib that can block cancer growth when used alongside chemotherapy drugs.See study design
What are the potential side effects?
Potential side effects include risks associated with bone marrow transplantation like infection and graft-versus-host disease. Sorafenib may cause rash, diarrhea, high blood pressure; chemotherapy can lead to nausea, fatigue, mouth sores.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a perfect match donor for my transplant.
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I am between 18 and 70 years old.
Select...
I have acute myeloid leukemia, regardless of flt3 status.
Select...
I can swallow and keep down pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) as defined by toxicity (Phase I)
Progression-free survival (PFS) (Phase II)
Secondary outcome measures
Graft failure
Incidence of acute and chronic graft versus host disease graded according to National Cancer Institute CTCAE version 4.0
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
+3 moreSide effects data
From 2020 Phase 2 trial • 40 Patients • NCT0190000212%
AST increase
12%
Hypertension
9%
Hyponatremia
9%
Fatigue
6%
Vomiting
6%
Nausea
6%
Dizziness
6%
Diarrhea
6%
ALT increase
3%
Weight Loss
3%
Hypertenstion
3%
Duodenal Ulcer
3%
Sepsis
3%
Acute Renal Failure
3%
Hypotension
3%
Hypophosphatemia
3%
Hematuria
3%
Hepatic Hemorrhage
3%
Urinary Retention
3%
Dyspnea
3%
Weakness
3%
Abdominal Pain
3%
Rectal Bleed
3%
Palmar-Planta Erythrodysesthesia
3%
Thrombocytopenia
3%
Hyperbilirubinemia
3%
Proteinuria
3%
Mucositis
3%
Encephalopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Sorafenib Tosylate, TheraSphere)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (sorafenib, busulfan, fludarabine, HSCT)Experimental Treatment8 Interventions
PRE-STEM CELL INFUSION: Patients receive sorafenib orally PO QD or BID on days -24 to -5, busulfan IV over 3 hours on days -20 and -13 and -6 and -3, and fludarabine IV over 1 hour on days -6 to -3 in the absence of disease progression or unacceptable toxicity.
STEM CELL INFUSION: Patients receive allogeneic HSCT IV in the absence of disease progression or unacceptable toxicity.
POST-STEM CELL INFUSION: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus PO BID beginning day 5 for about 50 days, filgrastim SC on day 7 and sorafenib PO BID beginning between days +30 and +120 for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients with matched unrelated donor receive mycophenolate mofetil PO TID or IV over 2 hours TID beginning on day 5 for up to 90 days for longer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Cyclophosphamide
1995
Completed Phase 3
~3770
Tacrolimus
2011
Completed Phase 4
~4740
Filgrastim
2000
Completed Phase 3
~3670
Fludarabine
2012
Completed Phase 3
~1080
Sorafenib
2014
Completed Phase 3
~1670
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Busulfan
2008
Completed Phase 3
~1120
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,440 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,290 Total Patients Enrolled
Uday R PopatPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
454 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no other cancers except possibly treated skin, cervical, or superficial bladder cancer, or any cancer cured over 3 years ago.I have a perfect match donor for my transplant.I am not pregnant and have taken a test within the last week to confirm.My leukemia is in its first full remission and is considered low risk.My blood pressure is high despite taking medication.I do not have serious heart problems like recent heart attacks or unstable angina.I have a wound, ulcer, or bone fracture that is not healing.I have a history of bleeding disorders, but not due to low platelet counts.I have not had serious lung bleeding or any other severe bleeding in the last month.I haven't taken strong medication like phenytoin or St. John's wort in the last 28 days.I am not pregnant or breast-feeding.I can follow the study plan and attend all required check-ups.I have not had major surgery in the last 30 days.I have previously been treated with inotuzumab or gemtuzumab.I am between 18 and 70 years old.I have acute myeloid leukemia, regardless of flt3 status.I agree to use birth control from the start of the study until 30 days after the last dose.I can swallow and keep down pills.I have had an organ transplant.I have a condition that affects how my body absorbs nutrients.I am on blood thinners like warfarin or heparin.I haven't had a stroke or similar event in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sorafenib, busulfan, fludarabine, HSCT)
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.
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