Acute Myeloid Leukemia Clinical Trial
Official title:
Phase II Study of Early Allogeneic Blood Stem Cell Transplantation During Induction-chemotherapy Induced Aplasia in High-risk Acute Myeloid Leukemia
Karyotype is a major prognostic risk factor in patients with acute myeloid leukemia (AML)
translating into unfavourable outcome in case of poor-risk cytogenetic aberrations. Several
studies have shown that allogeneic hematopoietic stem cell transplantation (HSCT) after
myeloablative conditioning rather than autologous HSCT or consolidation chemotherapy result
in long-term disease control in this group of patients when achieving a first complete
remission. Nevertheless, the complete remission rate achievable is significantly lower than
in patients with a more favourable risk profile. In fact, only the minority of AML patients
with poor-risk cytogenetics, although having a suitable donor, proceed to HSCT due to
refractory disease or infectious complications during induction chemotherapy (IC). Further,
new data show that the course of therapy can be estimated as early as two weeks after the
initiation of the first course of IC with patients presenting with more than 10 % marrow
blasts doing significantly worse than those with a better clearance of blasts. As a result,
the chance to obtain a durable remission is considerably low and most patients with bad-risk
cytogenetics or failure to achieve blast clearance do not proceed to an allogeneic approach.
Together these data indicate that early treatment intensification is warranted in order to
provide the potential curative benefit of allogeneic HSCT to the majority of high-risk AML
patients.
We have shown that reduced-intensity conditioning (RIC) followed by allogeneic PBSC applied
during aplasia after the first cycle of IC in newly-diagnosed high-risk AML patients is
feasible and can result in a sustained disease control. These data prompted us to further
evaluate in a prospective trial an early "up-front HSCT" in patients with newly-diagnosed
high-risk AML defined by karyotype and insufficient blast clearance after the first cycle of
IC.
The goal was to provide an allogeneic HSCT as early as possible after diagnosis in AML
patients.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 75 Years |
Eligibility |
Inclusion Criteria: - newly-diagnosed AML - either poor risk cytogenetics and/or bad response to the first cycle of IC defined by more than 10% marrow blasts on day 15 - HLA-compatible donor (maximum one HLA-antigen mismatch) Exclusion Criteria: - no donor - Age < 16 years > 75 years - Cardiac insufficiency requiring treatment or symptomatic coronary artery disease - Hepatic disease, with AST > 2 times normal - Severe hypoxemia , pO2 < 70 mm Hg, with decreased DLCO < 70% of predicted; or mild hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 60% of predicted - Impaired renal function (creatinine > 2 times normal or creatinine clearance < 50% for age, weight, height) - HIV-positive patients due to risk of reactivation or acceleration of HIV replication - Female patients who are pregnant or breast feeding due to risks to fetus from conditioning regimen and potential risks to nursing infants - Life expectancy severely limited by diseases other than malignancy |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University hospital Carl Gustav Carus | Dresden |
Lead Sponsor | Collaborator |
---|---|
University Hospital Carl Gustav Carus |
Germany,
Platzbecker U, Thiede C, Freiberg-Richter J, Röllig C, Helwig A, Schäkel U, Mohr B, Schaich M, Ehninger G, Bornhäuser M. Early allogeneic blood stem cell transplantation after modified conditioning therapy during marrow aplasia: stable remission in high-r — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total and relapse-free survival rate one year after the stem cell transplantation | 5 years | Yes | |
Secondary | Incidence of acute GvHD | 100 days | Yes | |
Secondary | Safety (evaluated after Common Terminology Criteria for Adverse Events [CTCAE] v 3.0) | 5 years | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Recruiting |
NCT04460235 -
Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma
|
Phase 4 | |
Completed |
NCT04022785 -
PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
Completed |
NCT03678493 -
A Study of FMT in Patients With AML Allo HSCT in Recipients
|
Phase 2 | |
Recruiting |
NCT05424562 -
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
|
||
Terminated |
NCT03224819 -
Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)
|
Early Phase 1 | |
Completed |
NCT03197714 -
Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Active, not recruiting |
NCT04070768 -
Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113
|
Phase 1 | |
Active, not recruiting |
NCT04107727 -
Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)
|
Phase 2 | |
Recruiting |
NCT04385290 -
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04920500 -
Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients
|
N/A | |
Recruiting |
NCT03897127 -
Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics
|
Phase 3 | |
Active, not recruiting |
NCT04021368 -
RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
|
Phase 1 | |
Recruiting |
NCT03665480 -
The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML
|
Phase 2/Phase 3 | |
Completed |
NCT02485535 -
Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant
|
Phase 1 | |
Enrolling by invitation |
NCT04093570 -
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
|
Phase 2 | |
Recruiting |
NCT04069208 -
IA14 Induction in Young Acute Myeloid Leukemia
|
Phase 2 | |
Recruiting |
NCT05744739 -
Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)
|
Phase 1 | |
Recruiting |
NCT04969601 -
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings
|
Phase 1/Phase 2 |