Sequential treatment with Cytoreductive therapy & transplant for Relapsed/ Refractory Acute Myeloid Leukemia, High Risk Myelodysplasia,or other High Risk Myeloid Malignancies

Phase 1

• Conditions: 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 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]; Relapsed/ Refractory Acute Myeloid Leukemia, High Risk Myelodysplasia,or other High Risk Myeloid Malignancies; 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)

• Registration Number: EUCTR2007-000806-64-GB
• Lead Sponsor: Barts Health NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-03
• Study Completion: 2014-12-09
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 54

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified