Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prospective Randomized Multicenter Phase II Trial of Low-dose Decitabine (DAC) Administered Alone or in Combination With the Histone Deacetylase Inhibitor Valproic Acid (VPA) and All-trans Retinoic Acid (ATRA) in Patients > 60 Years With Acute Myeloid Leukemia Who Are Ineligible for Induction Chemotherapy
Brief Summary: AML of the older patient constitutes a major unmet clinical need since the large majority will not be found eligible for induction chemotherapy. Reasons for this decision include host factors (comorbidities, reduced performance status, functional limitations due to age), leading to often poor tolerance of repeated chemotherapy courses and the unfavorable biology underlying this disease in older patients. Low dose Decitabine has shown very promising efficacy in high-risk MDS and is therefore a very promising approach also in older AML patients. Preliminary results from several centres have demonstrated excellent feasibility and good efficacy of this treatment. Therefore the investigators intend to investigate the effects of two drugs added onto low-dose Decitabine which have shown very promising synergistic effects in vitro and for which preliminary results indicate that the combination with low-dose Decitabine is very feasible.


Options:
A: Intervention Type: DRUG; Name: Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: early allogeneic PBSCT within induction therapy; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: autologous PBSCT; Assigned to Arm(s): N/A
B: Arm Label: Decitabine; Type: EXPERIMENTAL; Interventions: Drug: Decitabine | Arm Label: Decitabine+VPA; Type: EXPERIMENTAL; Interventions: Drug: Decitabine, Drug: VPA | Arm Label: Decitabine+ATRA; Type: EXPERIMENTAL; Interventions: Drug: Decitabine, Drug: ATRA | Arm Label: Decitabine+VPA+ATRA; Type: EXPERIMENTAL; Interventions: Drug: Decitabine, Drug: VPA, Drug: ATRA | Intervention Type: DRUG; Name: Decitabine; Assigned to Arm(s): Decitabine, Decitabine+ATRA, Decitabine+VPA, Decitabine+VPA+ATRA | Intervention Type: DRUG; Name: VPA; Assigned to Arm(s): Decitabine+VPA, Decitabine+VPA+ATRA | Intervention Type: DRUG; Name: ATRA; Assigned to Arm(s): Decitabine+ATRA, Decitabine+VPA+ATRA
C: Arm Label: Standard Daunorubicin Then Autologous HCT; Type: EXPERIMENTAL; Interventions: Biological: sargramostim, Drug: busulfan, Drug: cyclophosphamide, Drug: cytarabine, Drug: Daunorubicin, Procedure: Autologous HCT | Arm Label: High-dose Daunorubicin Then Autologous HCT; Type: EXPERIMENTAL; Interventions: Biological: sargramostim, Drug: busulfan, Drug: cyclophosphamide, Drug: cytarabine, Drug: Daunorubicin, Procedure: Autologous HCT | Arm Label: Standard Daunorubicin Then GO/Autologous HCT; Type: EXPERIMENTAL; Interventions: Biological: sargramostim, Drug: busulfan, Drug: cyclophosphamide, Drug: cytarabine, Drug: gemtuzumab ozogamicin (GO), Drug: Daunorubicin, Procedure: Autologous HCT | Arm Label: High-dose Daunorubicin Then GO/Autologous HCT; Type: EXPERIMENTAL; Interventions: Biological: sargramostim, Drug: busulfan, Drug: cyclophosphamide, Drug: cytarabine, Drug: gemtuzumab ozogamicin (GO), Drug: Daunorubicin, Procedure: Autologous HCT | Arm Label: Standard Daunorubicin Then Allogeneic HCT or no Consolidation; Type: ACTIVE_COMPARATOR; Interventions: Drug: cytarabine, Drug: Daunorubicin, Procedure: Allogeneic HCT | Arm Label: High-dose Daunorubicin Then Allogeneic HCT or no Consolidation; Type: EXPERIMENTAL; Interventions: Drug: cytarabine, Drug: Daunorubicin, Procedure: Allogeneic HCT | Intervention Type: BIOLOGICAL; Name: sargramostim; Assigned to Arm(s): High-dose Daunorubicin Then Autologous HCT, High-dose Daunorubicin Then GO/Autologous HCT, Standard Daunorubicin Then Autologous HCT, Standard Daunorubicin Then GO/Autologous HCT | Intervention Type: DRUG; Name: busulfan; Assigned to Arm(s): High-dose Daunorubicin Then Autologous HCT, High-dose Daunorubicin Then GO/Autologous HCT, Standard Daunorubicin Then Autologous HCT, Standard Daunorubicin Then GO/Autologous HCT | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): High-dose Daunorubicin Then Autologous HCT, High-dose Daunorubicin Then GO/Autologous HCT, Standard Daunorubicin Then Autologous HCT, Standard Daunorubicin Then GO/Autologous HCT | Intervention Type: DRUG; Name: cytarabine; Assigned to Arm(s): High-dose Daunorubicin Then Allogeneic HCT or no Consolidation, High-dose Daunorubicin Then Autologous HCT, High-dose Daunorubicin Then GO/Autologous HCT, Standard Daunorubicin Then Allogeneic HCT or no Consolidation, Standard Daunorubicin Then Autologous HCT, Standard Daunorubicin Then GO/Autologous HCT | Intervention Type: DRUG; Name: gemtuzumab ozogamicin (GO); Assigned to Arm(s): High-dose Daunorubicin Then GO/Autologous HCT, Standard Daunorubicin Then GO/Autologous HCT | Intervention Type: DRUG; Name: Daunorubicin; Assigned to Arm(s): High-dose Daunorubicin Then Allogeneic HCT or no Consolidation, High-dose Daunorubicin Then Autologous HCT, High-dose Daunorubicin Then GO/Autologous HCT, Standard Daunorubicin Then Allogeneic HCT or no Consolidation, Standard Daunorubicin Then Autologous HCT, Standard Daunorubicin Then GO/Autologous HCT | Intervention Type: PROCEDURE; Name: Autologous HCT; Assigned to Arm(s): High-dose Daunorubicin Then Autologous HCT, High-dose Daunorubicin Then GO/Autologous HCT, Standard Daunorubicin Then Autologous HCT, Standard Daunorubicin Then GO/Autologous HCT | Intervention Type: PROCEDURE; Name: Allogeneic HCT; Assigned to Arm(s): High-dose Daunorubicin Then Allogeneic HCT or no Consolidation, Standard Daunorubicin Then Allogeneic HCT or no Consolidation
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Cytarabine, Drug: Idarubicin, Drug: Etoposide, Drug: Pegfilgrastim | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Cytarabine, Drug: Idarubicin, Drug: Etoposide, Drug: All-trans retinoic acid, Drug: Pegfilgrastim | Intervention Type: DRUG; Name: Cytarabine; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Idarubicin; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Etoposide; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: All-trans retinoic acid; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Pegfilgrastim; Assigned to Arm(s): 1, 2

Answer: B