Hematopoietic Cell Transplantation for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Acute Myeloid Leukemia+3 MoreHematopoietic Cell Transplantation - Procedure
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing how well cytarabine, idarubicin, and daunorubicin work with or without pembrolizumab to treat patients with newly-diagnosed acute myeloid leukemia.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Secondary Acute Myeloid Leukemia
  • Therapy-Related Acute Myeloid Leukemia
  • Acute Myeloid Leukemia (AML) arising from Myelodysplastic Syndrome (MDS)

Treatment Effectiveness

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: From randomization to failure to achieve CR/CRi, relapse or death from any cause, assessed up to 5 years

At day 14
MRD negativity
At end of consolidation
Rate of MRD-negative CR
At time of count recovery after first cycle of consolidation therapy with chemotherapy and pembrolizumab
Percentage of patients with minimal residual disease - complete response (MRD-CR)
At time of count recovery after induction therapy with chemotherapy and pembrolizumab
Assess the rate of CR/incomplete count recovery (CRi)
Year 3
Immune cell subsets
PD-1 and PD-L1 expression
Protein signatures
Baseline
Genomic deoxyribonucleic acid (DNA) of tumor cells
Year 5
Duration of response (DOR)
Year 5
Relapse-free survival (RFS)
Year 5
Event-free survival
Day 35
Incidence of adverse events
Up to end of consolidation
MRD assessment
MRD detection
Year 3
Ribonucleic acid (RNA) integrity of formalin fixed paraffin-embedded RNA
T cell receptor (TCR) sequencing

Trial Safety

Side Effects for

Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)
48%Neutropenia
10%Death following disease progression post transplant
10%Hyperbilirubinemia
10%Thrombocytopenia
10%Hypoxia
5%Death: Sepsis/Renal failure/ with history of GVHD
5%Death following progression of GVHD
5%Renal failure
5%Hypotension
5%Minimal hydronephosis
5%Cardiac Arrhythmia and Seizure
5%Perforated sigmoid diverticulitis
5%Acute Pulmonary Embolism
5%Neurotoxicity
5%Typhlitis & Bowel Perforation
5%Severe abnormal pain due to gut GVH
5%Tumor lysis syndrome
5%Increased creatinine
5%Cholecystectomy
This histogram enumerates side effects from a completed 2010 Phase 2 trial (NCT00060424) in the Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis) ARM group. Side effects include: Neutropenia with 48%, Death following disease progression post transplant with 10%, Hyperbilirubinemia with 10%, Thrombocytopenia with 10%, Hypoxia with 10%.

Trial Design

2 Treatment Groups

Arm II (cytarabine, idarubicin, daunorubicin, HSCT)
1 of 2
Arm I (cytarabine, idarubicin, daunorubicin, HSCT)
1 of 2

Active Control

Experimental Treatment

124 Total Participants · 2 Treatment Groups

Primary Treatment: Hematopoietic Cell Transplantation · No Placebo Group · Phase 2

Arm I (cytarabine, idarubicin, daunorubicin, HSCT)Experimental Group · 5 Interventions: Cytarabine, Daunorubicin Hydrochloride, Idarubicin Hydrochloride, Hematopoietic Cell Transplantation, Pembrolizumab · Intervention Types: Drug, Drug, Drug, Procedure, Biological
Arm II (cytarabine, idarubicin, daunorubicin, HSCT)ActiveComparator Group · 4 Interventions: Cytarabine, Daunorubicin Hydrochloride, Idarubicin Hydrochloride, Hematopoietic Cell Transplantation · Intervention Types: Drug, Drug, Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Daunorubicin
FDA approved
Idarubicin
FDA approved
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~270
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to failure to achieve cr/cri, relapse or death from any cause, assessed up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,098 Previous Clinical Trials
41,145,653 Total Patients Enrolled
Amer M ZeidanPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
103 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with prior use of HMA, lenalidomide, erythropoiesis-stimulating agents (ESAs), and growth factors are allowed if used to treat prior MDS.
Children aged 6 to 17 years with a confirmed diagnosis of unresectable or metastatic solid tumors are eligible for this study.
You have a performance status of -2.
You are eligible to receive intensive \"7+3\" induction chemotherapy as judged by the treating physician.
Creatinine =< 1.5 x ULN OR measured or calculated CrCl > 60 mL/min for patient with creatinine levels > 1.
Creatinine clearance (CrCl) should be calculated per institutional standard.
GFR can be used in place of CrCl or Cr.