BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients With AML in Complete Remission With High Risk to Relapse
NCT01690624 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-01-27
Summary
Patients with acute myeloid leukemia who experience a relapse after at least one prior regimen may be enrolled in this trial. In addition, acute myeloid leukemia patients who are in complete remission with high risk to relapse may be eligible for this trial. The trial will examine whether monotherapy with BI 836858 is safe and tolerable at escalating dose levels.
Conditions
- Leukemia, Myeloid, Acute
Interventions
- DRUG
-
BI 836858
Monotherapy with BI 836858 administered as intravenous infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-09-13
- Primary Completion
- 2018-05-21
- Completion
- 2018-05-21
Countries
- United States
Study Locations
More Related Trials
-
BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)
NCT01296932 ·Status: COMPLETED ·Phase: PHASE1
-
Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients
NCT01838395 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes
NCT00981240 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
NCT06618001 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome
NCT03594955 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
NCT03106428 ·Status: COMPLETED ·Phase: PHASE1
-
BI 2536 Infusional Treatment in Patients Over 60 Years of Age With Refractory or Relapsed Acute Myeloid Leukaemia
NCT00701766 ·Status: COMPLETED ·Phase: PHASE2
-
Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Acute Lymphoblastic Leukemia (B-ALL)
NCT02669264 ·Status: TERMINATED ·Phase: PHASE1
-
Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib
NCT02759016 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Safety, Tolerability, and Efficacy of Tipifarnib Plus Bortezomib in the Treatment of Acute Myeloid Leukemia
NCT00510939 ·Status: UNKNOWN ·Phase: PHASE2
-
Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia
NCT00804856 ·Status: COMPLETED ·Phase: PHASE2
-
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
NCT02101853 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic Malignancies
NCT00710528 ·Status: COMPLETED ·Phase: PHASE1
-
BR101801 in Adult Patients With Advanced Hematologic Malignancies(Phase I)
NCT04018248 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes
NCT02240706 ·Status: TERMINATED ·Phase: PHASE2
-
Dose Escalation Study in Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia
NCT02215629 ·Status: WITHDRAWN ·Phase: PHASE1
-
Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT03194685 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of DCLL9718S in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Participants With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy
NCT03298516 ·Status: COMPLETED ·Phase: PHASE1
-
Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)
NCT01662505 ·Status: COMPLETED ·Phase: PHASE1
-
Decitabine and Bortezomib in Treating Patients With Acute Myeloid Leukemia
NCT00703300 ·Status: COMPLETED ·Phase: PHASE1
-
Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
NCT02129062 ·Status: TERMINATED ·Phase: PHASE2
-
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
NCT06137118 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Selumetinib in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia
NCT00588809 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
NCT06651229 ·Status: RECRUITING ·Phase: PHASE1
-
Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia
NCT03957915 ·Status: COMPLETED ·Phase: EARLY_PHASE1