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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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28 February 2019 |
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Main ID: |
EUCTR2007-000806-64-GB |
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Date of registration:
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03/06/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sequential treatment with Cytoreductive therapy & transplant for Relapsed/ Refractory Acute Myeloid Leukemia, High Risk Myelodysplasia,or other High Risk Myeloid Malignancies
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Scientific title:
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A Phase II Trial of Sequential treatment with Cytoreductive therapy and Reduced Intensity Conditioning Allogeneic Stem Cell Transplantation for Relapsed/ Refractory Acute Myeloid Leukemia, High Risk Myelodysplasia,or other High Risk Myeloid Malignancies - Sequential treatment with Cytoreductive therapy & transplant |
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Date of first enrolment:
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01/08/2007 |
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Target sample size:
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93 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000806-64 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Diagnosis of histologically documented AML (any WHO type), with primary induction failure, or at relapse where the patient is not a candidate or does not wish to proceed to a myeloablative transplant. Also, histologically / cytogenetically documented diagnosis of MDS (IPSS Int. 2, HR), or other high risk Myeloid Malignancy where the patient is not a candidate or does not wish to proceed to a myeloablative transplant.
2. All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures must have resolved to National Cancer Institute (NCI) Common Toxicity Criteria (CTC)(Version 3.0) Grade < 2 (with the exception of chemotherapy-induced alopecia). Surgery must have occurred at least 21 days prior to initiation of treatment.
3. Aged between 18 and 60 years (inclusive)
4. Last dose of antineoplastic therapy must be more than 14 days from starting treatment, except for hydroxyurea or Low Dose Ara C which may have been administered up to 24 hours prior to first study drug administration for leukoreduction.
5. ECOG performance status must be 0, 1, or 2.
6. Life expectancy of at least 2 months.
7. Pregnancy test (females of childbearing potential) Negative
8. Signed informed consent indicating that they are aware of the neoplastic nature of their disease and have been informed of the procedures to be followed, alternatives, potential benefits, side effects, risks, and discomforts.
9. Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Concurrent therapy with any other investigational agent.
2. Pregnant or breastfeeding women. All at-risk female subjects must have a negative pregnancy test within 10 days prior to the start treatment.
3. Clinically significant cardiac disease (New York Heart Association, Class III or IV)
4. Dementia or altered mental status that would prohibit informed consent.
5. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this study.
6. Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Relapsed/ Refractory Acute Myeloid Leukemia, High Risk Myelodysplasia,or other High Risk Myeloid Malignancies
MedDRA version: 14.1
Level: LLT
Classification code 10000886
Term: Acute myeloid leukemia
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1
Level: LLT
Classification code 10028532
Term: Myelodysplasia
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1
Level: LLT
Classification code 10060558
Term: Acute myeloid leukemia recurrent
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: Daunorubicin
Pharmaceutical Form:
INN or Proposed INN: Daunorubicin
Other descriptive name: Daunorubicin
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 45 mg/m2-
Product Name: Cytarabine Injection Solution 100mg/ml
Pharmaceutical Form:
INN or Proposed INN: Cytarabine
Other descriptive name: Cytarabine 100 mg/ml Injection
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100 mg/ml-
Product Name: Fludarabine
Pharmaceutical Form:
INN or Proposed INN: Fludarabine
Other descriptive name: Fludarabine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25mg per ml-
Product Name: Methotrexate
Pharmaceutical Form: Injection
INN or Proposed INN: Methotrexate
Other descriptive name: Methotrexate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25 mg/ml-
Product Name: Cyclophosphamide
Pharmaceutical Form: Injection
INN or Proposed INN: cyclophosphamide
Other descriptive name: cyclophosphamide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20mg per ml-
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Primary Outcome(s)
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Main Objective: To determine whether it is safer and more effective, in treating high risk Myeloid Malignancies, to immediately follow chemotherapy with Allogeneic Haemopoietic Stem Cell Transplantation than to treat in two distinct phases, with a break to determine remission status.
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Secondary Objective: 1) Event Free Survival (EFS) at 1, 2 and 4 years
2) Treatment Related Mortality (TRM) at d100, 1 and 2 years and cause of mortality.
3) Incidence and Grade of Acute Graft versus Host Disease (GVHD)
4) Incidence and Grade of Chronic GVHD.
5) Time to Engraftment*
6) Full Split Chimerism at Days 30, 60, 100 and 1 year.
7) Request for DLI (Mixed Chimerism vs. Disease persistence)
8) Incidence of Opportunistic Infections
9) Duration of Hospitalisation
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Primary end point(s): 1. Overall Survival (OS) at 1, 2 and 4 years.
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Timepoint(s) of evaluation of this end point: 4 years
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Secondary Outcome(s)
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Secondary end point(s): 2. Event Free Survival (EFS) at 1, 2 and 4 years
3. Treatment Related Mortality (TRM) at d100, 1 and 2 years and cause of mortality.
4. Incidence and Grade of Acute Graft versus Host Disease (GVHD)
5. Incidence and Grade of Chronic GVHD.
6. Time to Engraftment
7. Full Split Chimerism at Days 30, 60, 100 and 1 year.
8. Request for DLI (Mixed Chimerism vs. Disease persistence)
9. Incidence of Opportunistic Infections
10. Duration of Hospitalisation
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Timepoint(s) of evaluation of this end point: Between 100 days and 4 years
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Secondary ID(s)
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BLT004973
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ISRCTN32336114
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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