Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Myeloid Leukemia+3 MoreAllogeneic Hematopoietic Stem Cell Transplantation - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to find out if 90Y-DOTA-anti-CD25 basiliximab, given with fludarabine, melphalan, and total marrow and lymphoid irradiation, is an effective treatment for high-risk acute leukemia or myelodysplastic syndrome.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • Secondary Acute Myeloid Leukemia
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Treatment Effectiveness

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: From start of therapy up to 2 years post-transplant

Day 100
Incidence of chronic GVHD
Day 100
Bone Transplantation
Year 2
Overall survival
Year 2
Event-free survival
Year 2
Non-relapse mortality
Year 2
Relapse/progression
Year 2
Graft versus host disease and relapse free survival
Day 3
Neutrophil recovery
Day 30
Complete remission (CR) proportion at day +30
Day 100
Incidence of toxicities/adverse events
Day 100
Incidence of Infection
Day 30
Maximum tolerated dose/recommended phase II dose of 90Y-DOTA-antiradioimmunotherapy
Day 30
Incidence of toxicity

Trial Safety

Side Effects for

Treatment (Fludarabine, Transplant, Immunosuppression)
5%Febrile neutropenia
5%Hypoxia
5%Acute kidney injury
4%Blood bilirubin increased
4%Creatinine increased
4%Diarrhea
4%Sepsis
3%Bronchopulmonary hemorrhage
3%Chronic kidney disease
3%Hypotension
3%Lung infection
3%Left ventricular systolic dysfunction
3%Thromboembolic event
1%Gastric hemorrhage
1%Atrial fibrillation
1%Atrial flutter
1%Heart failure
1%Mucositis oral
1%Pleural effusion
1%Syncope
1%Multi-organ failure
1%Typhlitis
1%Respiratory failure
1%Treatment related secondary malignancy
1%Fever
1%Ejection fraction decreased
1%Paroxysmal atrial tachycardia
1%Gastritis
1%Hemolytic uremic syndrome
1%Ascites
1%Encephalitis infection
1%Hemolysis
1%Myalgia
1%Small intestine infection
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT01251575) in the Treatment (Fludarabine, Transplant, Immunosuppression) ARM group. Side effects include: Febrile neutropenia with 5%, Hypoxia with 5%, Acute kidney injury with 5%, Blood bilirubin increased with 4%, Creatinine increased with 4%.

Trial Design

1 Treatment Group

Treatment (90Y-basiliximab, fludarabine, melphalan, TMLI)
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Allogeneic Hematopoietic Stem Cell Transplantation · No Placebo Group · Phase 1

Treatment (90Y-basiliximab, fludarabine, melphalan, TMLI)Experimental Group · 9 Interventions: Total Marrow Irradiation, Indium In 111-DOTA-Basiliximab, Palifermin, Total Lymphoid Irradiation, Basiliximab, Melphalan, Allogeneic Hematopoietic Stem Cell Transplantation, Yttrium Y 90 Basiliximab, Fludarabine Phosphate · Intervention Types: Radiation, Drug, Biological, Radiation, Biological, Drug, Procedure, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Marrow Irradiation
2014
Completed Phase 1
~20
Palifermin
FDA approved
Total Lymphoid Irradiation
2008
Completed Phase 3
~160
Basiliximab
FDA approved
Mechlorethamine
FDA approved
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1280
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from start of therapy up to 2 years post-transplant

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
517 Previous Clinical Trials
2,249,589 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,084 Previous Clinical Trials
41,141,634 Total Patients Enrolled
Jeffrey Y WongPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
149 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with de novo or secondary disease in unfavorable risk group including poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for acute myeloid leukemia (AML) i.e.
You have provided informed consent of the participant and/or legally authorized representative.
You have a Karnofsky performance status of 70 or higher.
Patients with a complete morphological remission (CR) with MRD-positive status by flow cytometry or cytogenetics.
You have myelodysplastic syndrome in high-intermediate (int-2) or high-risk categories.