Acute Leukemia Clinical Trial
Official title:
Observational Study to Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia, Myelodysplastic Syndrome and Myelproliferative Neoplasms
NCT number | NCT02677064 |
Other study ID # | 16-024 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | February 2025 |
The investigators are doing this research study to assess the percentage of patients receiving stem cell transplantation for the type of blood cancer you have. They want to know how many patients get a transplant and why some patients do get a transplant while others do not. Also they want to explore why some patients elect not to undergo stem cell transplantation, when it is recommended by their physicians.
Status | Recruiting |
Enrollment | 1365 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients with newly diagnosed or relapsed acute leukemia. Patients undergoing reinduction due to primary induction failure are also eligible. Patients with acute leukemia will be enrolled to Arm A - Patients with diagnosis of MDS, MPN and MDS/MPN overlap who meet any of the following criteria (based on NCCN guidelines): - Clinically significant cytopenia of at least 2 cell lines affected; Hgb<10, - Platelet<100,000, absolute neutrophil count<1000 - Bone marrow blasts >5% and any level of circulating blasts - Evidence of disease progression or no response to hypomethylating agents/immunosuppressive treatment or a clinical trial. - IPSS Intermediate-1 and higher - IPSS-R intermediate and higher - All cases of therapy related MDS with excess blasts - In patients with Myelofibrosis: Low risk disease by DIPSS with either refractory, transfusion dependent anemia, circulating blasts cells greater than 2%; or adverse cytogenetics and any patient with DIPSS-intermidiate 1 and higher. - Patients with acute leukemia or MDS/MPN who relapse after first allografts. Patients with post-transplant relapse will be enrolled to Arm C. - Patients 18 years of age or older and 80 years of age or younger - For the purposes of this protocol "relapse" is defined as re-emergence of the initial abnormal myeloid blast population (or blast equivalent) comprising 5% or more of marrow WBC or any amount prompting a therapeutic intervention targeting relapsed disease, including, but not limited to withdrawal of immunosuppression, targeted therapies, chemotherapy, etc. Exclusion Criteria: - Patients with polycythemia vera (PV) and essential thrombocytosis (ET) |
Country | Name | City | State |
---|---|---|---|
United States | Lehigh Valley Health Network | Allentown | Pennsylvania |
United States | Hartford Healthcare Cancer Institute @ Hartford Hospital | Hartford | Connecticut |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of patients who proceed to transplant | determine whether an individual patient proceeded to HCT when he or she was considered eligible (based on NCCN guidelines. | 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05088356 -
Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
|
Phase 1 | |
Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
Recruiting |
NCT04969601 -
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings
|
Phase 1/Phase 2 | |
Recruiting |
NCT02356159 -
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05170828 -
Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
|
Phase 1 | |
Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
Active, not recruiting |
NCT01956630 -
Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT
|
Phase 1/Phase 2 | |
Completed |
NCT00988013 -
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
|
N/A | |
Enrolling by invitation |
NCT01728402 -
Pathogenesis of Hematologic Malignancies
|
||
Active, not recruiting |
NCT03595800 -
Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen
|
Phase 3 | |
Completed |
NCT02440178 -
Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia
|
Phase 2 | |
Recruiting |
NCT05071482 -
Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL
|
Phase 4 | |
Withdrawn |
NCT03138395 -
iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML
|
N/A | |
Completed |
NCT03042676 -
Electronic Database for the Follow up of the ATG_FamilyStudy
|
||
Completed |
NCT04597086 -
Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients
|
N/A | |
Terminated |
NCT03588936 -
Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant
|
Phase 1 | |
Recruiting |
NCT05521204 -
Olverembatinib for FGFR1-rearranged Neoplasms
|
Phase 2 | |
Not yet recruiting |
NCT04084327 -
Immunophenotyping of Acute b Cell Lymphoblstic Leukemia
|
||
Terminated |
NCT00852709 -
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias
|
Phase 1 | |
Not yet recruiting |
NCT06026839 -
Longitudinal Study on the QoL of Pediatric Patients After HSCT and Its Influencing Factors
|