Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02724163
Other study ID # RG_14-088
Secondary ID 2014-005066-30
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 2016
Est. completion date December 2032

Study information

Verified date September 2021
Source University of Birmingham
Contact Christina Ryan
Phone 01214151049
Email myechild01@trials.bham.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is : 1. To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses) is tolerated and can be safety delivered in combination with cytarabine plus mitoxantrone or liposomal daunorubicin in induction 2. To compare mitoxantrone (anthracenedione) & cytarabine with liposomal daunorubicin (anthracycline) & cytarabine as induction therapy. (Randomisation 1 (R1) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.) 3. To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with induction chemotherapy. 4. To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine & cytarabine (FLA) in standard risk patients. 5. To compare the toxicity and effectiveness of two haemopoietic stem cell transplant (HSCT) conditioning regimens of different intensity: conventional myeloablative conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning (RIC) with fludarabine/busulfan.


Description:

MyeChild 01 is an international phase III clinical trial in children with acute myeloid leukaemia (AML); a disease with significant mortality. It will compare two induction chemotherapy regimens: mitoxantrone and cytarabine (current standard treatment) with liposomal daunorubicin and cytarabine. This will test liposomal daunorubicin, which is believed to be less cardiotoxic than similar conventional drugs, although this is unproven. (Randomisation 1 (R1) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.) Patients responding well to induction chemotherapy are eligible for a randomisation of two consolidation regimens: high dose cytarabine (current standard treatment) or fludarabine and cytarabine (FLA); a regimen commonly used in patients with relapsed disease, testing whether FLA is more effective in front line therapy than standard consolidation treatment. Patients with cytogenetic features associated with a higher risk of relapse and those responding sub-optimally to induction treatment are candidates for haemopoietic stem cell transplant (HSCT) and are eligible for a randomisation comparing two HSCT conditioning regimens: myeloablative conditioning (MAC) (current UNited Kingdom (UK) standard) or reduced intensity conditioning (RIC). HSCT has not consistently shown benefit in high risk patients because the mortality associated with the procedure has outweighed the advantage from a reduction in relapse risk. This will test whether reducing the intensity of conditioning improves survival by reducing transplant related deaths without increasing the relapse rate. The trial incorporates a dose finding study for gemtuzumab ozogamicin. The aim is to identify the optimum tolerated number of doses of gemtuzumab ozogamicin (up to a total of 3 doses), which can be safely combined with either of the induction chemotherapy regimens and then to compare this number of doses with one dose of gemtuzumab ozogamicin. The intensity of treatment will be directed by cytogenetics/molecular genetics and response assessed by minimal residual disease (MRD) levels measured by flow cytometry and molecular methodology.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date December 2032
Est. primary completion date December 2031
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: Inclusion criteria for trial entry - Diagnosis of acute myeloid leukaemia (AML) /high risk Myelodysplastic syndrome (MDS) (>10% blasts in the bone marrow)/isolated myeloid sarcoma (MS) (either de novo or secondary). - Age <18 years at trial entry. - No prior chemotherapy or biological therapy for AML/high risk MDS/isolated MS other than that permitted in the protocol. - Normal cardiac function defined as fractional shortening =28% or ejection fraction =55%. - Fit for protocol chemotherapy. - Documented negative pregnancy test for female patients of childbearing potential. - Patient agrees to use effective contraception (patients of child bearing potential). - Written informed consent from the patient and/or parent/legal guardian. Inclusion criteria for participation in the gemtuzumab ozogamicin dose finding study: Centres must be formally activated in order to be take part in the embedded dose escalation study. Please contact the trial office for further information. - Patient meets the inclusion criteria for trial entry. - Age: - =12 months for the major dose finding study - = 12 weeks and <12 months for the minor dose finding study - Normal renal function defined as calculated creatinine clearance =90ml/min/1.73m2. - Normal hepatic function defined as total bilirubin =2.5 upper limit of normal (ULN) for age unless it is caused by leukaemic involvement or Gilbert's syndrome or similar disorder. - Alanine transaminase (ALT) or aspartate transaminase (AST) =10 x ULN for age. - Written informed consent from the patient and/or parent/legal guardian. Inclusion criteria for treatment with gemtuzumab ozogamicin for patients not participating in the gemtuzumab ozogamicin dose finding study or R2. - Patient meets the inclusion criteria for trial entry (section 4.1.1) - Age: - =12 months - = 12 weeks - =28 days and <12 weeks (patients will receive a maximum of one dose of gemtuzumab ozogamicin) - Normal renal function, defined as calculated creatinine clearance =90 ml/min/1.73m2 - Normal hepatic function, defined as total bilirubin =2.5 upper limit of normal (ULN) for age and not due to leukaemic involvement or Gilbert's syndrome or similar disorder - ALT or AST =10 x ULN for age - Written informed consent from the patient and/or parent/legal guardian Inclusion criteria for participation in R2.(once open to randomisation in the applicable age group) • Patient meets the inclusion criteria for trial entry Patient age: - =12 months - =12 weeks (once R2 open in patients aged =12 weeks and <12 months) - Normal renal function defined as calculated creatinine clearance =90ml/min/1.73m2. - Normal hepatic function defined as total bilirubin =2.5 ULN for age and not due to leukaemic involvement or Gilbert's syndrome or similar disorder. - ALT or AST =10 x ULN for age. - Written informed consent from the patient and/or parent/legal guardian. Inclusion criteria for participation in R3. - Patient meets the inclusion criteria for trial entry - Induction treatment as per MyeChild 01 protocol or treated with 2 courses of mitoxantrone & cytarabine off trial. - Minimal residual disease (MRD) response (performed in MyeChild 01 centralised laboratories, see national MyeChild 01 Laboratory Manual): - Patients with good risk cytogenetics/molecular genetics and a MRD level <0.1% by flow after course 2, or a decrease in transcript levels of >3 logs after course 2 for those with an informative molecular marker, but without an informative marker of sufficient sensitivity for flow MRD monitoring or - Patients with intermediate risk cytogenetics/molecular genetics with a MRD level <0.1% by flow after course 1 and course 2, or a decrease in transcript levels of >3 logs after course 1 and course 2 for those with an informative molecular marker, but without an informative marker of sufficient sensitivity for flow MRD monitoring. - Written informed consent from the patient and/or parent/legal guardian. Inclusion criteria for participation in R4. - Patient meets the inclusion criteria for trial entry - Induction treatment as per MyeChild 01 protocol or treated with 1 or 2 courses of mitoxantrone & cytarabine ± treatment intensification with fludarabine, cytarabine & idarubicin (FLA-Ida) off trial. - Patient is in complete remission (CR) or CR with incomplete blood count recovery (CRi) defined as <5% blasts confirmed by flow cytometry/ molecular/FISH in a bone marrow aspirate taken within 6 weeks prior to randomisation to R4. - Patient meets one of the following criteria and is a candidate for HSCT as per the protocol: - High risk after course 1 (all patients with poor risk cytogenetics and patients with intermediate risk cytogenetics who fail to achieve CR/CRi). - Intermediate risk cytogenetics with MRD >0.1% after course 1 and 2 measured by flow. If no flow MRD marker of sufficient sensitivity is identified, a molecular MRD marker with a sensitivity of >0.1% may be used. - Good risk cytogenetics with flow MRD >0.1% confirmed by a decrease in molecular MRD of <3 logs or rising transcript levels after course 3 despite treatment intensification (FLA-Ida) and after discussion with the Clinical Co-ordinators. - Availability of a 9-10/10 human leukocyte antigen (HLA) matched family or unrelated donor or 5-8/8 matched cord blood unit with an adequate cell dose as defined by the protocol section 17.1. - Written informed consent from the patient and/or parent/legal guardian. Exclusion Criteria: Exclusion criteria for all randomisations - Acute Promyelocytic Leukaemia. - Myeloid Leukaemia of Down Syndrome. - Blast crisis of chronic myeloid leukaemia. - Relapsed or refractory AML. - Bone marrow failure syndromes. - Prior anthracycline exposure which would inhibit the delivery of study anthracyclines. - Concurrent treatment or administration of any other experimental drug or with any other biological therapy for AML/high risk MDS/isolated MS. - Pregnant or lactating females.

Study Design


Intervention

Drug:
Gemtuzumab ozogamicin
Antibody-conjugated chemotherapy agent.
Liposomal daunorubicin
Anthracycline (Randomisation 1 (R1)) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.
Mitoxantrone
DNA-reactive agent
Fludarabine
A water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine.
Cytarabine
Pyrimidine nucleoside analogue, an antineoplastic agent.
Busulfan
Alkylsulfonate
Cyclophosphamide
A nitrogen mustard alkylating agent from the oxazaphosphorine group

Locations

Country Name City State
Australia Women and Children's Hospital Adelaide Adelaide
Australia Queensland Children's Hospital Brisbane
Australia Monash Children's Hospital Melbourne
Australia Royal Childrens Hospital Melbourne
Australia John Hunter Children's Hopsital New Lambton Heights
Australia Perth Children's Hospital Perth
Australia Sydney Children's Hospital Sydney
Australia The Childrens Hospital At Westmead Westmead
France Centre Hospitalier Universitaire Amiens - Picardie Amiens
France Centre Hospitalier Universitaire D'angers Angers
France Centre Hospitalier Regional Universitaire Besancon - Hopital Jean Minjoz Besançon
France Centre Hospitalier Universitaire De Bordeaux - Hopital Pellegrin Bordeaux
France Centre Hospitalier Regional Universitaire Brest - Hopital Morvan Brest
France Centre Hospitalier Universitaire De Caen Caen
France Centre Hospitalier Universitaire De Clermont-ferrand Clermont-Ferrand
France Centre Hospitalier Universitaire Dijon Bourgogne - Hopital D'enfants Dijon
France Centre Hospitalier Universitaire De Grenoble Grenoble
France Hopital Jeanne Dr Flandre Lille
France Centre Hospitalier Universitaire De Limoges Limoges
France Centre Leon Berard Lyon
France Hopital De La Timone Marseille
France Centre Hospitalier Regional Universitaire Montpellier - Hopital Arnaud-de-villeneuve Montpellier
France Centre Hospitalier Universitaire De Nancy Nancy
France Centre Hospitalier Universitaire De Nantes Nantes
France Centre Hospitalier Universitaire De NICE Nice
France Hopital Armand Trousseau Paris
France Hopital Robert Debre Paris
France Hopital Saint Louis Paris
France Centre Hospitalier Universitaire De Poitiers Poitiers
France Chu De Reims Reims
France Centre Hospitalier Universitaire De Rennes - Hopital Sud Rennes
France Centre Hospitalier Universitaire De Rouen Rouen
France Centre Hospitalier Universitaire Saint-etienne Saint-Étienne
France Strasbourg Hautepierre Strasbourg
France Centre Hospitalier Universitaire De Toulouse - Hopital Des Enfants Toulouse
France Centre Hospitalier Regional Universitaire De Tours - Hopital Clocheville Tours
Ireland Our Lady's Hospital for Sick Children Dublin
New Zealand Starship Childrens Hospital Auckland
New Zealand Christchurch Hospital Christchurch
Switzerland Kantonsspital Aarau Aarau
Switzerland Universitäts-Kinderspital beider Basel
Switzerland Ospedale San Giovanni Bellinzona
Switzerland Inselspital Bern Bern
Switzerland Hug Hopitaux Universitaires De Geneve Geneve
Switzerland Centre Hospitalier Universitaire Vaudois Chuv Lausanne Lausanne
Switzerland Luzerner Kantonspital - Kinderspital Luzern Lucerne
Switzerland Ostschweizer Kinderspital St. Gallen
Switzerland University Children's Hospital Zurich Zurich
United Kingdom Aberdeen Royal Infirmary, NHS Grampian Aberdeen
United Kingdom Royal Aberdeen Children's Hospital Aberdeen
United Kingdom Royal Belfast Hospital for Sick Children Belfast County Antrim
United Kingdom Birmingham Children's Hospital NHS Foundation Trust Birmingham
United Kingdom University Hospitals Bristol NHS Foundation Trust Bristol
United Kingdom Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust Cambridge
United Kingdom Cardiff and Vale University Health Board, Noah's Ark Children's Hospital for Wales Cardiff
United Kingdom NHS Lothian, Royal Hospital for Sick Children Edinburgh
United Kingdom NHS Greater Glasgow and Clyde, The Royal Hospital for Children Glasgow
United Kingdom Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust Leeds
United Kingdom Alder Hey Children's NHS Foundation Trust Liverpool
United Kingdom Great Ormond Street Hospital For Children NHS Trust London
United Kingdom The Royal Marsden NHS Foundation Trust London
United Kingdom University College London Hospitals NHS Foundation Trust London
United Kingdom Royal Manchester Childrens' Hospital , Central Manchester University Hospitals NHS Foundation Trust Manchester
United Kingdom The Newcastle Upon Tyne Hospitals NHS Foundation Trust Newcastle
United Kingdom Nottingham University Hospitals NHS Trust Nottingham
United Kingdom John Radcliffe Hospital, Oxford Radcliffe Hospitals NHS Trust Oxford
United Kingdom Sheffield Children's NHS Foundation Trust Sheffield
United Kingdom Southampton University Hospitals NHS Trust Southampton

Sponsors (5)

Lead Sponsor Collaborator
University of Birmingham Assistance Publique - Hôpitaux de Paris, Cancer Research UK, National Cancer Institute, France, Pfizer

Countries where clinical trial is conducted

Australia,  France,  Ireland,  New Zealand,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of dose limiting toxicities (DLTs). Incidence of DLTs will be evaluated up to day 45 post course 1 and course 2 of induction chemotherapy.
Primary Event Free Survival (EFS). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals. Event free survival (EFS) will be evaluated as the time from randomisation one to the first event, up to 16 years.
Primary Event Free Survival (EFS). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals. Event free survival (EFS) will be evaluated as the time from randomisation two to the first event, up to 16 years..
Primary Relapse free survival (RFS). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. RFS estimates will be presented at 24 months along with 95% confidence intervals. Relapse free survival (RFS) will be evaluated as the time of randomisation three to the first relapse or death from any cause, up to 16 years.
Primary Early treatment related adverse reactions. Early treatment related adverse reactions defined as the incidence by day 100 post-transplant of grade 3-5 toxicity for the following systems using the National Cancer Institute (NCI) Common Terminology Criteria v4:
Cardiac (pericardial effusion/Left ventricular systolic dysfunction).
Respiratory, thoracic and mediastinal (hypoxia/pneumonitis).
Gastrointestinal (GI) (diarrhoea/typhlitis/upper and lower GI haemorrhage).
Investigations (bilirubin).
Renal and Urinary (acute kidney injury/haematuria).
Nervous system (seizure).
Early treatment related adverse reactions will be evaluated at day 100 post-transplant.
Primary Relapse free survival (RFS). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. RFS estimates will be presented at 12 months along with 95% confidence intervals. Relapse free survival (RFS) will be evaluated as the time of randomisation four to the first relapse or death from any cause, up to 16 years.
Secondary The nature, incidence and severity of adverse events (AEs) (gemtuzumab ozogamicin dose finding study). Evaluated by day 45 post course 1 and course 2.
Secondary Response measured by bone marrow assessment using morphology and minimal residual disease (MRD) assessment (gemtuzumab ozogamicin dose finding study). Response is assessed by morphology confirmed by MRD levels measured by flow cytometry, molecular methods or fluorescence in situ hybridisation (FISH) as defined in the protocol, in combination with platelet and neutrophil counts. These results of these assessments will be combined to determine the patient's disease response using the response criteria defined in the protocol. Evaluated by day 45 post course 1 and course 2.
Secondary Serum pharmacokinetic (PK) parameters of gemtuzumab ozogamicin: Clearance (CL) (gemtuzumab ozogamicin dose finding study) Serum PK parameters will be measured using serial samples taken at multiple timepoints during course 1 and at 1 month post first dose of gemtuzumab ozogamicin as defined in the protocol by dose cohort. Evaluated up to one month after the first dose of gemtuzumab ozogamicin.
Secondary Serum pharmacokinetic (PK) parameters of gemtuzumab ozogamicin: Volume of distribution (Vd) (gemtuzumab ozogamicin dose finding study) Serum PK parameters will be measured using serial samples taken at multiple timepoints during course 1 and at 1 month post first dose of gemtuzumab ozogamicin as defined in the protocol by dose cohort. Evaluated up to one month after the first dose of gemtuzumab ozogamicin.
Secondary Complete remission (CR) (R1 & R2). Evaluated using remission status at completion of course 1 and course 2. Evaluated and presented at the completion of course 1 and 2 of treatment up to a maximum of 45 days post each course of treatment
Secondary Reasons for failure to achieve CR (R1 & R2). Evaluated as resistant disease, induction death or not evaluable.This will be evaluated at completion of course 1 and 2 of treatment, once patient's blood counts have recovered or reason for non-recovery has been determined. Evaluated and presented at the completion of course 1 and 2 of treatment, up to a maximum of 45 days post each course of treatment.
Secondary Cumulative Incidence of Relapse (CIR) (all randomisations). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. CIR estimates will be presented at 24 months along with 95% confidence intervals for randomisations 1, 2 and 3, and at 12 months for randomisation 4. Evaluated as time from randomisation to the relevant question to relapse, up to 16 years.
Secondary Death in CR (DCR) (R1, R2 & R3). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. DCR estimates will be presented at 24 months along with 95% confidence intervals. Evaluated as time from randomisation to relevant question to date of death from any cause in patients who have achieved CR, up to 16 years.
Secondary Event Free Survival (EFS) (R1, R2 & R3). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals. Evaluated as time from randomisation to the relevant question to the first of failure to achieve CR (recorded as an event on day 1), relapse, secondary malignancy or death from any cause, up to 16 years.
Secondary Overall Survival (OS) (all randomisations). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. OS estimates will be presented at 24 months along with 95% confidence intervals for randomisations 1, 2 and 3, and at 12 months for randomisation 4. Evaluated as time from randomisation to the relevant question to death from any cause or date last seen for patients who are alive at the end of the trial, up to 16 years.
Secondary Incidence of toxicities (all randomisations). Evaluated 30 days after end of trial treatment.
Secondary Incidence of cardiotoxicity (R1, R2 & R4 only). Evaluated 30 days after end of trial treatment.
Secondary Incidence of bilirubin of grade 3 of higher (R2 & R4 only). Evaluated 30 days after end of trial treatment.
Secondary Incidence of Veno-Occlusive Disease (R2 & R4 only). Evaluated 30 days after end of trial treatment.
Secondary Minimal Residual Disease (MRD) clearance after course 1 & 2 (R1 & R2 only). Evaluated using MRD result at completion of course 1 and 2 once patient's blood counts have recovered or reason for non-recovery has been determined. Evaluated and presented at completion of course 1 and 2 of treatment, up to a maximum of 45 days post each course of treatment.
Secondary Time to haematological recovery (all randomisations). Evaluated using the date of haematological recovery (platelets to >=80 x 10^9/L, and neutrophils to >=1.0 x 10^9/L). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. Time to haematological recovery estimates will be presented at 45 days post course 1 and course 2 of treatment along with 95% confidence intervals. Evaluated by day 45 post course 1 and course 2.
Secondary Days in hospital after each course of treatment (all randomisations). Total number of days spent in hospital for each course of treatment, collected from date of randomisation until count recovery after final course of treatment, up to a maximum of 45 days post the final course of treatment. This will be summarised per course of treatment. Evaluated once all patients have completed trial treatment.
Secondary Incidence of mixed chimerism at day 100 post-transplant (R4 only). Evaluated at day 100 post-transplant.
Secondary Treatment Related Mortality (TRM) (R4 only). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up which is estimated to be 7 years after the start of recruitment. TRM estimates will be presented at 12 months along with 95% confidence intervals. Evaluated as time in days between randomisation to R4 and death which is unrelated to the underlying disease and considered related to the transplant procedure.
Secondary Gonadal function (R4 only). The method of assessment will be by scale (Tanner scale) and physiological parameters. This will be evaluated at 1 year post-transplant and at the end of study follow-up. Evaluated at 1 year post-transplant and at the end of follow-up, which is estimated to be through to study completion, an average timeframe of 10 years.
See also
  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
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
Completed NCT01497002 - Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a Phase 3