Leukemia Clinical Trial
Official title:
Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (SCT) for AML With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children's Oncology Group (COG) Study
Verified date | July 2016 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that
closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops
the patient's immune system from rejecting the donor's stem cells. The donated stem cells may
replace the patient's immune cells and help destroy any remaining cancer cells
(graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an
immune response against the body's normal cells. Giving antithymocyte globulin before
transplant and cyclosporine, tacrolimus, and methotrexate before and after transplant may
stop this from happening.
PURPOSE: Natural Killer (NK) cells from the donor's bone marrow may be important in fighting
leukemia. Bone marrow donors can be selected based on the type of NK cells they have,
specifically the killer immunoglobulin receptor (KIR) type. This study provides information
on KIR type from potential donors, which can be used in selecting the bone marrow donor. This
phase II trial of unrelated donor stem cell transplant in patients with high risk AML
(monosomy 7, -5/5q-, high FLT3-ITD AR, or refractory or relapsed AML) in which KIR typing of
the patients and potential donors will be available to the treating transplant physician at
the time of donor selection.
Status | Completed |
Enrollment | 158 |
Est. completion date | March 31, 2020 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 30 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of one of the following: - Patients with primary refractory acute myeloid leukemia (AML), defined as = 5% bone marrow blasts after two induction courses of chemotherapy - Primary refractory AML, defined as = 5% bone marrow blasts after two induction courses of chemotherapy - AML or myelodysplastic syndrome with -5/5q- or monosomy 7 without inv(16)/t(16;16) or t(8;21) cytogenetics or NPM or CEBPa mutations - Relapsed AML (= 5% bone marrow blasts) who meet the customary WHO criteria for AML - AML and high FLT3 internal tandem duplication allelic ratio (high FLT3-ITD AR), defined as > 0.4 - All cases of therapy-related AML (therapy-related AML is considered high risk) - Patients with AML, without inv(16)/t(16;16) or t(8;21), monosomy 7, -5/5q-, NPM, or CEPBa mutations, or high FLT3-ITD AR, but with evidence of residual AML (= 0.1%) at the end of Induction I; or if a minimal residual disease (MRD) is not performed, then with > 15% bone marrow blasts by morphology after one induction course of chemotherapy - Any flow-based MRD is eligible for AAML05P1 for patients not on AAML1031, whereas patients on AAML1031 must utilize the central lab as per the AAML1031 protocol guidelines - No Fanconi anemia - Recipients of unrelated marrow or cord blood are eligible for this study PATIENT CHARACTERISTICS: - Karnofsky performance status (PS) (for patients over 16 years of age) or Lansky PS (for patients 16 and under) 50-100% - Total bilirubin = 2 mg/dL - SGOT (AST) or SGPT (ALT) = 2.5 times upper limit of normal - DLCO = 50% OR a normal chest x-ray and pulse oximetry in patients who are unable to undergo pulmonary function tests - Shortening fraction = 27% by ECHO - Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min OR creatinine adjusted according to age - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Patients with proven or suspected bacterial sepsis, pneumonia, or meningitis are eligible provided appropriate therapeutic measures have been initiated to control the presumed or proven infection, and systemic signs are not life-threatening - No evidence or presence of a fungal infection within the past 30 days PRIOR CONCURRENT THERAPY: - Prior chemotherapy, radiotherapy or any antileukemic therapy allowed provided patients meet 1 of the following criteria: - Received initial treatment for relapsed AML - Patients with primary induction failure or relapse who have already received initial therapy and who may have gone on to have additional therapy prior to receiving protocol stipulated therapy on AAML05P1 - No treatment for fungal infection within the past 30 days - Concurrent radiotherapy to localized painful lesions allowed - No other concurrent cancer chemotherapy or immunomodulating agents |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Hopital Sainte Justine | Montreal | Quebec |
Canada | Hospital for Sick Children | Toronto | Ontario |
Canada | Children's and Women's Hospital of British Columbia | Vancouver | British Columbia |
United States | AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia |
United States | Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland |
United States | UAB Comprehensive Cancer Center | Birmingham | Alabama |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
United States | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Rainbow Babies and Children's Hospital | Cleveland | Ohio |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas |
United States | Dayton Children's - Dayton | Dayton | Ohio |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida |
United States | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas |
United States | Hackensack University Medical Center Cancer Center | Hackensack | New Jersey |
United States | Penn State Children's Hospital | Hershey | Pennsylvania |
United States | Riley's Children Cancer Center at Riley Hospital for Children | Indianapolis | Indiana |
United States | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa |
United States | University of Mississippi Cancer Clinic | Jackson | Mississippi |
United States | Nemours Children's Clinic | Jacksonville | Florida |
United States | Children's Mercy Hospital | Kansas City | Missouri |
United States | East Tennessee Children's Hospital | Knoxville | Tennessee |
United States | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky |
United States | Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach | California |
United States | Kosair Children's Hospital | Louisville | Kentucky |
United States | Children's Hospital Central California | Madera | California |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
United States | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York |
United States | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma |
United States | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska |
United States | Nemours Children's Clinic - Orlando | Orlando | Florida |
United States | Nemours Children's Clinic - Pensacola | Pensacola | Florida |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri |
United States | All Children's Hospital | Saint Petersburg | Florida |
United States | Primary Children's Medical Center | Salt Lake City | Utah |
United States | Methodist Children's Hospital of South Texas | San Antonio | Texas |
United States | Rady Children's Hospital - San Diego | San Diego | California |
United States | CCOP - Scott and White Hospital | Temple | Texas |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Alfred I. duPont Hospital for Children | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Disease-free Survival | The cumulative incidence of relapse or death after SCT will be calculated by considering relapse and death due to other causes as competing events. | From the date of SCT to the date of relapse, the date of death, or the date of last follow-up, whichever occurs first | |
Other | Acute and Chronic Graft-versus-host Disease | Acute and chronic GVHD will be summarized. | Up to 5 years | |
Other | Time to the Donor-specific NK-cell Receptor Expression | The presence of donor cells is demonstrated by the detection of informative variable-number tandem-repeat polymorphisms or by fluorescent in situ hybridization with a Y-chromosome-specific probe in cases of sex-mismatched transplants. Independent variables that will be examined include donor-recipient KIR mismatch, taking into consideration the interactions with donor-recipient human leukocyte antigen (HLA) compatibility, and the numbers of CD34+ cells and CD3+ cells in the graft. | Up to 42 days after SCT | |
Primary | Overall Survival (OS) | OS - Time from HSCT until death | At 5 years from HSCT date | |
Primary | Cumulative Incidence of NK Cell Reconstitution | Cumulative incidence of successful reconstitution to donor level is calculated. | At 5 years from HSCT date |
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