A Phase 1/2 interventional study of Fludarabine and Melphalan in Acute Myeloid Leukemia, sponsored by Seagen Inc.. Terminated at 11 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by Seagen Inc. · Phase 1/2, Interventional, and Treatment
This study will examine the safety and anti-leukemic profile of SGN-CD33A (vadastuximab talirine) in patients with relapsed chemo-resistant AML, who are given vadastuximab talirine in sequence with standard treatments before a planned stem cell transplant, or as maintenance therapy after a stem cell transplant. The main purpose of the study is to find the best dose and determine the anti-leukemic activity of vadastuximab talirine, given either pre- or post-allogeneic stem cell transplant (alloSCT) for adults with relapsed or refractory AML. This will be determined by assessing the safety and tolerability of vadastuximab talirine. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 14 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Seagen Inc. is the lead sponsor of 84 studies on the registry; 1 is open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Drug: Fludarabine · Drug: Melphalan · Drug: vadastuximab talirine
Post-allo vadastuximab talirine
Drug: vadastuximab talirine
30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan 140 mg/m2 intravenously, 2 days before the transplant
Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
Post-allo (after stem cell transplant) given on Day 1 of each cycle
Incidence of Adverse Events
AE: Adverse events; TEAE: Treatment-emergent adverse event. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. An AE is considered serious if it was fatal, life threatening, required hospitalization, was disabling/incapacitating, resulted in a birth defect or congenital anomally, or was otherwise considered to be medically significant.
Time frame: Approximately 1 year
Incidence of Laboratory Abnormalities
Number (count) of participants that experienced a Grade 3 or higher laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
Time frame: Approximately 1 year
1-year Survival Rate
1-year survival rate estimated using Kaplan-Meier methods The start date for overall survival is the day of alloSCT.
Time frame: 12 months
Rate of MRD Negativity
Rate of MRD (minimal residual disease) negativity at Day -1 (1 day prior to transplant) and Day 30 post-transplant (Part A only)
Time frame: 30 days
Best Response of CR or CRi
Percentage of patients who achieved a best response of CRi (complete remission with incomplete blood count recovery) or CR (complete remission)
Time frame: 9 weeks
Duration of Response
Defined as the time from the start of the first documented complete response (CR) or complete remission with incomplete blood count recovery (CRi) to the documentation of relapse or death due to any cause.
Time frame: 9 weeks
Overall Survival
Defined as the time from the day of alloSCT to the date of death due to any cause.
Time frame: Approximately 96 weeks
| Milestone | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) |
|---|---|---|
| Started | 6 | 8 |
| Completed | 0 | 6 |
| Not completed | 6 | 2 |
| Withdrew: Death | 6 | 2 |
AE: Adverse events; TEAE: Treatment-emergent adverse event. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. An AE is considered serious if it was fatal, life threatening, required hospitalization, was disabling/incapacitating, resulted in a birth defect or congenital anomally, or was otherwise considered to be medically significant.
| Participants | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) |
|---|---|---|
| TEAEs | 6 | 8 |
| AEs Related to Vadatuximab Talirine | 6 | 7 |
| AEs Leading to Treatment Discontinuation | 0 | 1 |
| Grade 3 or Higher TEAEs | 6 | 6 |
| Serious AEs | 5 | 2 |
Number (count) of participants that experienced a Grade 3 or higher laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
| Participants | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) |
|---|---|---|
| Any chemistry test | 4 | 3 |
| Amylase (iu/l) | 3 | 0 |
| Alanine aminotransferase (iu/l) | 1 | 1 |
| Aspartate aminotransferase (iu/l) | 1 | 0 |
| Total bilirubin (mg/dl) | 3 | 0 |
| Uric acid (mg/dl) | 1 | 0 |
| Lipase (iu/l) | 0 | 1 |
| Sodium (meq/l) | 0 | 1 |
| Any hematology test | 6 | 5 |
| Hemoglobin (g/dl) | 3 | 0 |
| Lymphocytes (x10^3/ul) | 6 | 1 |
| Neutrophils (x10^3/ul) | 6 | 4 |
| Platlets (x10^3/ul) | 6 | 4 |
| White blood cell count (x10^3/ul) | 6 | 5 |
1-year survival rate estimated using Kaplan-Meier methods The start date for overall survival is the day of alloSCT.
| percentage of participants | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) |
|---|---|---|
| 1-year Survival Rate | 0 (NA to NA) | 75 (31 to 93) |
Rate of MRD (minimal residual disease) negativity at Day -1 (1 day prior to transplant) and Day 30 post-transplant (Part A only)
| Percentage of participants | Pre-allo (Before Stem Cell Transplant) |
|---|---|
| Day -1 Rate of MRD Negativity | NA (NA to NA) |
| Day 30 Rate of MRD Negativity | 75 (19.4 to 99.4) |
Percentage of patients who achieved a best response of CRi (complete remission with incomplete blood count recovery) or CR (complete remission)
| Participants | Pre-allo (Before Stem Cell Transplant) |
|---|---|
| Best Response of CR or CRi | 4 |
Defined as the time from the start of the first documented complete response (CR) or complete remission with incomplete blood count recovery (CRi) to the documentation of relapse or death due to any cause.
| weeks | Pre-allo (Before Stem Cell Transplant) |
|---|---|
| Duration of Response | 6.57 (3 to 9) |
Defined as the time from the day of alloSCT to the date of death due to any cause.
| weeks | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) |
|---|---|---|
| Overall Survival | 11.07 (7.43 to 15.71) | NA (31.14 to NA) |
Collected over Up to approximately 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-allo (Before Stem Cell Transplant) | 6/6 (100%) | 5/6 (83.3%) | 6/6 (100%) |
| Post-allo (After Stem Cell Transplant) | 2/8 (25%) | 2/8 (25%) | 8/8 (100%) |
| Event | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) |
|---|---|---|
| Acute kidney injuryRenal and urinary disorders | 2/6 | 0/8 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/6 | 0/8 |
| PyrexiaGeneral disorders | 1/6 | 0/8 |
| Venoocclusive liver diseaseHepatobiliary disorders | 1/6 | 0/8 |
| Graft versus host disease in gastrointestinal tractImmune system disorders | 1/6 | 0/8 |
| Device related infectionInfections and infestations | 1/6 | 0/8 |
| ParotitisInfections and infestations | 1/6 | 0/8 |
| SepsisInfections and infestations | 1/6 | 0/8 |
| Urinary tract infectionInfections and infestations | 1/6 | 0/8 |
| Transfusion reactionInjury, poisoning and procedural complications | 1/6 | 0/8 |
| Event | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) |
|---|---|---|
| NauseaGastrointestinal disorders | 5/6 | 2/8 |
| Oedema peripheralGeneral disorders | 5/6 | 1/8 |
| InsomniaPsychiatric disorders | 5/6 | 0/8 |
| VomitingGastrointestinal disorders | 4/6 | 2/8 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/6 | 0/8 |
| NeutropeniaBlood and lymphatic system disorders | 1/6 | 5/8 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/6 | 5/8 |
| DiarrhoeaGastrointestinal disorders | 3/6 | 1/8 |
| StomatitisGastrointestinal disorders | 3/6 | 0/8 |
| FatigueGeneral disorders | 3/6 | 4/8 |
| Age, Continuous(years) | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) | Total |
|---|---|---|---|
| Median | 58.0 (50 to 69) | 58.0 (25 to 64) | 58.0 (25 to 69) |
| Sex: Female, Male(Participants) | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 3 | 5 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 6 | 7 | 13 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 5 | 8 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) | Total |
|---|---|---|---|
| United States | 6 | 8 | 14 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | Pre-allo (Before Stem Cell Transplant) | Post-allo (After Stem Cell Transplant) | Total |
|---|---|---|---|
| Grade 0: Normal activity | 0 | 1 | 1 |
| Grade 1: Symptoms but ambulatory | 6 | 7 | 13 |
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Seagen Inc.