Phase I study of S 78454 in the treatment of patients with acute myeloid leukemia, acute lymphoblastic leukemia or myelodysplastic syndrome

Phase 1

Completed

• Conditions: Acute myeloid leukemia, acute lymphoblastic leukemia or myelodysplastic syndrome.; Cancer; Acute myeloid leukemia

• Registration Number: ISRCTN99680465
• Lead Sponsor: Pharmacyclics LLC (USA)

Brief Summary

1. 2012 results in https://www.ncbi.nlm.nih.gov/pubmed/23087409 (added 22/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-09
• Study Completion: 2015-09-30
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Male or female patient aged > or equal to 18
2. Ability to swallow oral capsule(s)
3. Estimated life expectancy > 8 weeks
4. ECOG performance status < or equal to 2
5. Adequate renal and hepatic functions
6. Left ventricular ejection fraction within normal limits
7. Patients with AML as defined by WHO 2008 classification, excluding acute promyelocytic leukemia
8. Patients with high or intermediary risk (IPSS int-2) myelodysplastic syndrome (MDS) as defined by WHO 2008 classification and IPSS, who have failed hypomethylating therapy (5 azacytidine)
9. Patients with histologically or cytologically confirmed B-cell ALL as defined by WHO 2008 revised classification, excluding Philadelphia chromosome-positive (Ph+) ALL (or BCR-ABL+) and B-cell ALL 3 Burkitt like, who have failed conventional or investigational therapy

Exclusion Criteria

1. Major surgery within previous 4 weeks
2. Diagnosis of acute promyelocytic leukemia, Philadelphia chromosomepositive (Ph+) ALL (or BCR-ABL+) or B-cell ALL 3 Burkitt like
3. Patients who have not recovered from toxicity of previous antileukaemic therapy, including grade < or equal to 1 non-haematologic toxicity
4. Any previous chemotherapy for AML within at least 2 weeks (or at least 5 half-life whichever is longer), except for hydroxyureas which must be stopped within 24 hours before starting the study drug)
5. Neutrophil growth factor stimulating agent (G-CSF) within previous one week
6. Last dose of biological therapy or immunotherapy agent (therapeutic or diagnostic) less than 7 days prior to the first study drug intake
7. Any concurrent treatment with anticoagulants (curative or preventive),
8. Any radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
9. Patients with history of allogeneic stem cell transplant of less than 6 months or with active graft versus host disease requiring immune suppressive therapy
10. Patients with active disseminated intravascular coagulation (DIC) (plasma fibrinogen <1 g/L)
11. Presence of heart disorders or clinically significant heart diseases
12. Pregnant or breastfeeding women, women of child-bearing potential without effective contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified