Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UMN-2004LS073 | Other Identifier | Clinical Trials Office, University of Minnesota | |
| UMN-MT2004-25 | Other Identifier | Blood and Marrow Transplantation Program |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This clinical trial is studying how well a peripheral stem cell transplant using NK cells from a donor works in treating patients with relapsed acute myeloid leukemia.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
After completion of study treatment, patients are followed periodically for 3 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intent-to-Treat | Experimental | All patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10^7/kg.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aldesleukin | Biological | 10 million units three times a week for a total of 6 doses. For any subject less than 45 kilograms the IL-2 will be given at 5 million units per meter squared three times weekly for a total of 6 doses |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Natural Killer (NK) Cell Expansion | Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14). | Study Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Complete Remission | Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery). | Day 28-35 |
| Median Time to Disease Relapse (Months) |
Not provided
Inclusion Criteria:
Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
Related HLA-haploidentical natural killer cell donor available
No severe organ damage (by clinical or laboratory assessment)
Performance status 50-100%
No evidence of active infection on chest X-ray
No active fungal infection
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Miller, MD | Masonic Cancer Center, University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24719405 | Derived | Bachanova V, Cooley S, Defor TE, Verneris MR, Zhang B, McKenna DH, Curtsinger J, Panoskaltsis-Mortari A, Lewis D, Hippen K, McGlave P, Weisdorf DJ, Blazar BR, Miller JS. Clearance of acute myeloid leukemia by haploidentical natural killer cells is improved using IL-2 diphtheria toxin fusion protein. Blood. 2014 Jun 19;123(25):3855-63. doi: 10.1182/blood-2013-10-532531. Epub 2014 Apr 9. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Relapsed/Refractory Acute Myeloid Leukemia | Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| therapeutic allogeneic lymphocytes | Biological | Cells infused per kg. 1.5-8.0 x 10^7/kg Total cells infused(for 70 kg. adult) 1.05 - 5.6 x 10^9 |
|
|
| cyclophosphamide | Drug | Days -5 and -4: 60 mg/kg |
|
|
| fludarabine phosphate | Drug | Days -5 through -2: 25 mg/m^2 |
|
|
| in vitro treated peripheral blood stem cell transplantation | Procedure | Day 0 infuse natural killer cells |
|
|
Follow-up continued every 3 months after the allogeneic natural killer (NK) cell infusion, unless they were transplanted, relapsed or had progressive disease. Time in months to relapse of disease is calculcated from 1st day of treatment with NK cells. Relapse occurs when leukemia is detected in bone marrow or blood. |
| From 1st Day of treatment until death or receipt of bone marrow transplant. |
| Overall Survival Time of Patients With Complete Remission | Median number of months patients were alive after NK cell infusion. | From Day 1 of Treatment until death or patient received bone marrow transplant. |
| Number of Patients With Complete Remission and Natural Killer Cell Expansion | Includes patients who had both a complete remission of disease and an expansion of natural killer cells. | Day 14 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Relapsed/Refractory Acute Myeloid Leukemia | Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Natural Killer (NK) Cell Expansion | Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14). | Posted | Dec 2009 | Number | Participants | Study Day 14 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients With Complete Remission | Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery). | Posted | Dec 2009 | Number | Participant | Day 28-35 |
|
| |||||||||||||||||||||||||||
| Secondary | Median Time to Disease Relapse (Months) | Follow-up continued every 3 months after the allogeneic natural killer (NK) cell infusion, unless they were transplanted, relapsed or had progressive disease. Time in months to relapse of disease is calculcated from 1st day of treatment with NK cells. Relapse occurs when leukemia is detected in bone marrow or blood. | Only 2 of 20 patients that received adequate Natural Killer Cells achieved complete remission, and were therefore evaluable for the time to relapse endpoint. | Posted | Jun 2009 | Median | Full Range | Months | From 1st Day of treatment until death or receipt of bone marrow transplant. |
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival Time of Patients With Complete Remission | Median number of months patients were alive after NK cell infusion. | Posted | Jun 2009 | Median | Full Range | Months | From Day 1 of Treatment until death or patient received bone marrow transplant. |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients With Complete Remission and Natural Killer Cell Expansion | Includes patients who had both a complete remission of disease and an expansion of natural killer cells. | Unable to evaluate due to low complete remission rate. | Posted | Sep 2009 | Day 14 |
|
|
Events were monitored from Day 1 of study through Day 60 post-natural killer cell infusion.
All "other" adverse events that occurred were expected and not captured.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Relapsed/Refractory Acute Myeloid Leukemia | Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled. | 19 | 21 | 0 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to progressive disease | General disorders | CTCAE (3.0) | Systematic Assessment | unrelated to study |
|
| Hemorrhage, CNS | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | central nervous system |
|
| Hemorrhage, lung | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | pulmonary/upper respiratory-lung |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Meningitis x2, pneumonia, associated with lymphopenia |
|
| Leukoencephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | radiographic findings |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Miller, M.D. | Masonic Cancer Center, University of Minnesota | 612-625-7409 | mille011@umn.edu |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C082598 | aldesleukin |
| D007376 | Interleukin-2 |
| D018655 | Lymphocyte Count |
| D003520 | Cyclophosphamide |
| C042382 | fludarabine phosphate |
| C496971 | IL32 protein, human |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D007958 | Leukocyte Count |
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|