An Open Label Randomized Controlled Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients with Primary Refractory or Relapsed Acute Myeloid Leukemia

Phase 2

• Registration Number: CTRI/2010/091/000624
• Lead Sponsor: Antisoma Research ltdChiswick Park Building 5, 566 Chiswick High Road, London, W4 5YF United Kingdom

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

1. Willing and able to provide written informed consent and in the opinion of the Investigator able to comply with the study assessments and follow-up.
2. Diagnosis of AML as defined by the World Health Organization (WHO) classification(Vardiman, 2009)
3. Primary refractory AML (defined as a failure to achieve a CR or CRi after therapy with curative intent) or AML in first relapse
4. ECOG performance status 0, 1 or 2
5. Age ≥18 and ≤ 70 years
6. Total bilirubin < 2 x ULN, or direct (conjugated) bilirubin < 2 x ULN
7. AST < 5 x ULN, ALT < 5 x ULN
8. Creatinine < 1.5 x ULN (or if creatinine is &#8805; 1.5 times ULN, creatinine clearance > 50ml/min using the Cockcroft-Gault formula)
9. For patients presenting with primary refractory AML, &#8805; 20% blasts on baseline bone marrow assessment
10. For patients presenting with relapsed AML, &#8805; 5% blasts on baseline bone marrow assessment

Exclusion Criteria

1. Unwilling to accept the required per protocol sample collection, including extra bone marrow assessments, blood sample collections
2. An initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976)
3. Secondary AML, defined as AML evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent
4. Clinically active CNS leukemia
5. White blood cell count > 20 billion/L (Patients treated with leukophoresis and/or hydroxyurea to bring down the WBC prior to study entry are not excluded)
6. Previously received a total cumulative dose of cytarabine > 6g/m2 in the last 6 months
7. Previously received> 1 induction regimen (Defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)except if a preceding CR/CRi/CRp lasted > 6 months
8. Known allergy to cytarabine
9. Pregnant or nursing
10. Women of childbearing potential or sexually active males unless (1) the patient is surgically sterile or 2) using adequate contraception (defined as either IUD, oral or depot contraceptive, or barrier plus spermicide) while receiving study treatment and for at least 6 months after termination of treatment . Women must be post-menopausal for at leat 2 years to be considered of non-child bearing potential
11. Known HIV positivity where the condition is not well managed using antiretroviral therapies
12. Serious uncontrolled infection rendering the patient unsuitable for high dose cytarabine treatment
13. Psychiatric illness or social situation that would preclude study compliance
14. Treatment with other investigational agents for any reason within 28 days prior to study entry
15. Any uncontrolled illness
16. Other malignancy, survival from which is anticipated to be &#8804; 2 years from study entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified