Dexamethasone in first relapsed or refractory acute myeloid leukemia

Phase 1

• Conditions: Relapse or refractory Acute Myeloid Leukemia; MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10060558 Term: Acute myeloid leukemia recurrent System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10000889 Term: Acute myeloid leukemia without mention of remission System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001467-23-FR
• Lead Sponsor: CHU de Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 142

Inclusion Criteria

- 18 years of age or older
- Diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) classification. First relapsed or refractory AML with at least 5% blasts by bone marrow biopsy or aspirate, or at least 1% blasts in peripheral blood, and meeting the following criteria :
First relapsed AML:
* First relapse occurred at least 90 days to 24 months after the first CR or CRi.
* The first CR or CRi had to result from no more than 2 cycles of cytotoxic chemotherapy. At least 1 induction cycle must have consisted of an anthracycline and cytarabine combination with a reasonable schedule/dose of anthracycline in the judgment of the investigator.
* The re-emergence of at least 5% leukemic blasts in bone marrow is not attributable to other causes, regardless of new or recurrent dysplastic changes or extramedullary disease, or the re-emergence of at least 1% blasts in the peripheral blood is not attributable to other causes such as regenerating marrow.
Refractory AML:
* Persistent AML was documented by bone marrow biopsy or aspirate at least 28 days after day 1 of the first induction cycle of 1 or 2 cycles of cytotoxic chemotherapy.
* Re-emergence of at least 5% leukemic blasts in bone marrow or at least 1% blasts in peripheral blood is not attributable to other causes such as regenerating marrow, and was less than 90 days after the first CR or CRi.
* Prior induction therapy had to include no more than 2 cycles of cytotoxic chemotherapy. At least 1 induction cycle must have consisted of an anthracycline and cytarabine combination with a reasonable schedule/dose of anthracycline in the judgment of the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status = 2
- Left ventricular ejection fraction (LVEF) = 50% by echocardiogram or multi-gated acquisition (MUGA) scan; only applicable for patients who will receive intensive chemotherapy
- Serum creatinine = 150 µmol/L and/or total bilirubin = 1.5 × the upper limit of normal (ULN) and/or, aspartate aminotransferase (AST) = 2.5 × ULN and/or alanine aminotransferase (ALT) = 2.5 × ULN (unless related to AML or due to Gilbert’s syndrome)
- Any clinically significant non-hematological toxicity after prior chemotherapy must be resolved or of grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
- Women must be surgically or biologically sterile, or in post-menopause (amenorrheic for at least 12 months), or if of childbearing potential, must have a negative urine or serum pregnancy test within 14 days prior to the randomization, and agree to use a highly effective method of contraception throughout the entire duration of the study treatment (including dose interruptions) and until 3 months after the last study treatment administration. Men must be surgically or biologically sterile, or agree to use a highly effective method of contraception throughout the entire duration of the study treatment (including dose interruptions) and until 6 months after the last study treatment administration
- Registered to, or beneficiary of, social security insurance or equivalent
- Signed written informed consent by both the patient and the investigator prior to perf

Exclusion Criteria

- Acute promyelocytic leukemia (M3 subtype of AML)
- More than 2 cycles of first line induction chemotherapy
- AML with Philadelphia chromosome or BCR-ABL1 or blast crisis stage of chronic myeloid leukemia
- Known or suspected central nervous system leukemia
- Undergoing allogeneic hematopoietic stem cell transplantation within 90 days prior to randomization, or being on immunosuppressive therapy for prophylaxis of graft-versus-host disease (GVHD), or experiencing GVHD within 2 weeks prior to randomization
- Use of any experimental, cytotoxic, or targeted, anti-leukemic therapy within 14 days prior to randomization, with the exception of hydroxyurea
- Formal contraindication to glucocorticoids
- Non-AML-associated organic or psychiatric severe disease that contraindicates use of study treatment
- Patients who may not be followed regularly in consultation because of psychological, family, social, or geographical reasons
- History of uncontrolled other malignancy for at least two years, with the exception of basal cell carcinoma and in situ cervix carcinoma
- Severe uncontrolled infection at time of inclusion
- Positive serology for HIV-1 or 2, and/or HTLV-1 or 2, and/or active viral infection with hepatitis B virus (HBV) and/or hepatitis C virus (HCV)
- Pregnant (beta HCG positive) or breastfeeding woman
- Incapable patient of age, under guardianship, curatorship or safeguard of justice
- Patient Under State Medical Assistance
- Patient participating in any other interventional clinical trial or having participated in an interventional clinical trial of which the exclusion period is still ongoing.

Study & Design

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