Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Amonafide

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Amonafide 600 mg/m2 IV over 4 hours daily on days 1-5 in combination with cytarabine 200 mg/m2 IV continuous infusion (CI) daily on days 1-7

Amonafide + cytarabine

A phase IIa study to evaluate the pharmacokinetic and efficacy of amonafide L-malate (AS1413) in combination with cytarabine in treating patients with acute myeloid leukemia (AML)

A Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Patients With Acute Myeloid Leukemia (AML)

A Phase IIa Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Adult Patients With Acute Myeloid Leukemia (AML)

Antisoma Research

Fredrik Erlandsson

Symptoms and General Pathology

Syndrome

Preleukemia

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Neoplasm Metastasis

Bone Marrow Diseases

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Chronic Disease

Disease Attributes

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Tacrolimus

Venetoclax

Fludarabine

Fludarabine phosphate

Mycophenolic Acid

Treosulfan

Amsacrine

Calcineurin Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Venetoclax treatment will be started orally once a day with food, one day before FLAMSA conditioning therapy and stopped the day before high-dose Treosulfan. The total duration of treatment with Venetoclax will be 6 days (day -11 to -6 before stem cell infusion). Patients with active disease at transplant will receive a 3-day ramp-up prephase of Ara-C (100mg total dose infused in 1h) with daily increasing doses of Venetoclax to prevent TLS during conditioning. Total treatment duration with Venetoclax in patients with active disease at transplant will be 8 days (day -13 to -6 before stem cell infusion).

Study treatment consists of the conditioning therapy including 6 or 8 days of Venetoclax treatment.

Amsacrine is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation

Ara-C is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation

Ara-C

Tacrolimus is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards.

Mycophenolate Mofetil is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards.

Mycophenolate Mofetil

Guido Kobbe, Prof. Dr.

Edgar Jost, Prof. Dr.

Gesine Bug, PD Dr.

Inken Hilgendorf, Prof. Dr.

Udo Holtick, PD Dr.

Mareike Verbeek, Dr.

This trial aims to find the MTD of Venetoclax when added to Fludarabin, Amsacrine and Ara-C + Treosulfan and to evaluate whether the addition of Venetoclax to sequential conditioning with FLAMSA + Treosulfan is safe for allogeneic blood stem cell transplantation in patients with high-risk MDS, CMML or sAML (FLAMSAClax)

Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML

Phase-I/II Trial to Assess the Safety and Efficacy of Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML (FLAMSAClax

maximal organ toxicity to each organ system according to CTC criteria as well as the number of AEs of grade III or greater within the first 30 days (± 3) after transplantation

maximal organ toxicity to each organ system according to CTC criteria as well as the number of AEs of grade III or greater until day +100 (± 7) after transplantation

Number of patients with graft failure (no donor chimerism at day +30 (± 3) after transplantation)

Incidence of aGvHD during the first 2 years after transplantation

Course of aGvHD during the first 2 years after transplantation (response/no response to steroids)

Severity of aGvHD during the first 2 years after transplantation (according to Glucksberg criteria)

Incidence of cGvHD during the first 2 years after transplantation

Course of cGvHD during the first 2 years after transplantation (response/no response to steroids)

Severity of cGvHD during the first 2 years after transplantation (according to NIH criteria)

Incidence, course and severity of VOD (according to EBMT criteria)

Time (days from day 0) to hematopoietic reconstitution (ANC\>500/µl, PLT\>20000/µl and PLT\>50000/µl)

Time (days from day 0) to transfusion independence

Best disease response within the first 100 days (± 7) after transplantation (according to IWG-criteria for MDS and ELN-criteria for AML)

Disease response and donor chimerism at day +30 (± 3), +60 (± 7) and +100 (± 7) after transplantation (according to IWG-criteria for MDS and ELN-criteria for AML)

Time (days from day 0) to complete donor chimerism in blood and marrow

Disappearance of individual molecular markers of disease (time in days from day 0)

Event-free survival (death,relapse and disease progression will be recorded as event)

Cumulative incidence of relapse (disease progression and relapse will be recorded as event)

Overall survival (OS, death will be recorded as event)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Patients With Acute Myeloid Leukemia (AML)	NCT01066494	Acute Myeloid L...	Amonafide + cyt...	18 Years -	Antisoma Research
Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML	NCT05807932	Myelodysplastic... Secondary Acute... Chronic Myelomo...	Venetoclax Amsacrine Ara-C Tacrolimus Mycophenolate M...	18 Years -	Heinrich-Heine University, Duesseldorf
A Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Patients With Acute Myeloid Leukemia (AML)	NCT01066494	Acute Myeloid L...	Amonafide + cyt...	18 Years -	Antisoma Research

Spots Global Cancer Trial Database for saml

Every month we try and update this database with for saml cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for saml

Every month we try and update this database with for saml cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for saml cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.