Acute Myeloid Leukaemia Clinical Trial
Official title:
Randomised Comparison of OSHO Induction vs. the German AML Intergroup Standard, Randomised Comparison of AraC/Mtx vs. Flu/AraC/Mtx in Pts Without CR After One Induction Cycle and Randomized Comparison of One vs. Two Consolidation Therapies.
This protocol is part of the German AML Intergroup Trial, where the OSHO study arm is
compared to the common German standard arm after randomization in a 9:1 ratio. The
hypothesis involves primarily dosing and application of AraC for induction. It is expected
that CR rates and as a consequence also LFS are higher in protocols using higher AraC
compared to lower doses and that LFS might be superior in the study specific arm compared to
the golden standard published several years ago. In the standard arm, AraC 100mg/m2/day is
given as continuous infusion over 7 days. Daunorubicin is given as 60 mg/m2/day over a two
hours infusion on days 3, 4 und 5. On day 22 a second induction course is applied. After
reaching CR, three cycles of AraC 3 g/m2 over three hours bid are infused on day 1, 3 und 5.
In contrast the OSHO arm consists of induction therapy with IDA 12 mg/m*2 over 20-30-min-iv
on day 1 - 3 and AraC 2 x 1 g/m*2 bid over 3-h-iv on days 1+3+5+7.
A previous phase II study of the OSHO has shown high CR in patients with relapsed AML using
MitoFlag. In this study we asked the question if MitoFlag is superior to IdaAraC in newly
diagnosed AML patients without CR after the first induction chemotherapy. Therefore patients
are randomized to receive either MitoFlag or IdaAraC and the difference in CR rates
evaluated.
It is still unclear if two consolidation therapies are needed before allogeneic or
autologous stem cell transplantation. This question is being addressed in the second part of
the OSHO study, where patients are randomized to receive either one or two consolidation
therapies.
In this study all patients with AML and an age of 18-60 years except M3 are entered
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02272478 -
Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations
|
Phase 2/Phase 3 | |
| Completed |
NCT03672695 -
Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia.
|
Phase 1 | |
| Completed |
NCT01019161 -
An Open Label, Single Centre Mass Balance C14 Study in Patients With Acute Myeloid Leukaemia (AML)
|
Phase 1 | |
| Completed |
NCT00530699 -
Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)
|
Phase 1 | |
| Not yet recruiting |
NCT06326697 -
Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)
|
Phase 1 | |
| Completed |
NCT01597219 -
Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers
|
Phase 2 | |
| Completed |
NCT01063660 -
Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)
|
Phase 2 | |
| Terminated |
NCT05712278 -
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia
|
Phase 1 | |
| Terminated |
NCT03217838 -
Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.
|
Phase 1 | |
| Withdrawn |
NCT04106076 -
Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia
|
Phase 1 | |
| Active, not recruiting |
NCT04217278 -
A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT
|
Phase 2/Phase 3 | |
| Completed |
NCT02844257 -
Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukaemia
|
N/A | |
| Active, not recruiting |
NCT01716364 -
Safety Study of Anti LewisY Chimeric Antigen Receptor in Myeloma, Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
| Recruiting |
NCT06345365 -
MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
|
Phase 3 | |
| Completed |
NCT01422603 -
Clofarabine Pre-conditioning With Allogeneic Transplant for Acute Myeloid Leukaemia (AML)
|
Phase 1/Phase 2 | |
| Completed |
NCT04629443 -
Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02189824 -
Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
|
Phase 1 | |
| Recruiting |
NCT02724163 -
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia
|
Phase 3 | |
| Completed |
NCT01621724 -
WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study
|
Phase 1/Phase 2 | |
| Completed |
NCT01236144 -
A Trial to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.
|
Phase 1/Phase 2 |