A CLINICAL STUDY TO EXPLORE THE EFFICACY, SAFETY AND TOLERABILITY OF DEUTERIUM DEPLETED WATER IN PREVIOUSLY UNTREATED PATIENTS WITH ASYMPTOMATIC CHRONIC LYMPHOCYTIC LEUKEMIA.

Phase 1

• Conditions: Previously untreated patients with asymptomatic chronic lymphocytic leukemia but who are at high risk of progression.; MedDRA version: 18.1Level: LLTClassification code 10060576Term: Chronic lymphoid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-003820-30-SK
• Lead Sponsor: HYD Pharma Zrt.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-30
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Written and signed informed consent according to local guidelines.
2. Male and female subjects >= 18 years of age.
3. Body weight <= 90 kg.
4. Histopathologically confirmed diagnosis of asymptomatic early stage CLL (Binet A) who are at high risk of progression (= 2 risk factors).
5. No previous treatment for asymptomatic early stage CLL (Binet A).
6. ECOG performance status <= 2.
7. Life expectancy >= 6 months.
8. Adequate liver function as defined as:
a. Serum (total) bilirubin <= 2 x the upper limit of normal (ULN)
b. Aspartate aminotransferase (ASAT) or serum glutamic oxaloacetic transaminase (SGOT) <= 2,5 x ULN
c. Alanine aminotransferase (ALAT) or serum glutamic-pyruvix transaminase (SGPT) <= 2,5 x ULN
d. Alkaline phosphatase (AP) <= 2,5 x ULN
9. Adequate renal function as defined as:
a. Serum creatinine <= 1.5 ULN

b. Aspartate aminotransferase (ASAT) or serum glutamic oxaloacetic transaminase (SGOT) <= 2,5 x ULN
c. Alanine aminotransferase (ALAT) or serum glutamic-pyruvix transaminase (SGPT) <= 2,5 x ULN
d. Alkaline phosphatase (AP) <= 2,5 x ULN
9. Adequate renal function as defined as:
a. Serum creatinine <= 1.5 ULN

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 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Subjects currently consuming or who have already consumed DDW.
2. History of other malignancy, other than non-basal-cell carcinoma of the skin or in situ carcinoma of the cervix unless the tumor was treated with curative intent at least 2 years previously which could affect the diagnosis or assessment of CLL.
3. Subjects with any of the following concurrent conditions:
• Evidence or history of significant cardiovascular, endocrine or metabolic disease
• Unstable angina pectoris, uncontrolled arrhythmia and cardiac insufficiency (NYHA Class III-IV).
• Serious intercurrent medical conditions that may interfere with the planned treatment (including human immunodeficiency virus (HIV)-positive, serious active infection, central nervous system (CNS) disease, psychiatric illness.) Patient with active infections requiring systemic antibiotics should be excluded from the study until resolution of infection.
• Clinically significant hepatic or renal disease.
• Evidence or history of alcohol-, drug and/or medical abuse.
• Other severe, concurrent disease(s) or mental disorder.
4. Subjects who have been hospitalized, had surgery with full recovery or have received emergency treatment in the 4 weeks prior to the start of the study.
5. Subjects currently receiving other investigational medication or who have received investigational medication in the month prior to the screening of the study.
6. Subjects who are unlikely to be compliant or attend scheduled clinic visits and follow up as required or who are unlikely to be compliant with the recommendations of the protocol, in particular subjects who undertake regular sporting or above average physical activity.
7. Employees of the Sponsor or the contract research organization (CRO) responsible for the execution of the study.
8. For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel).
9. Pregnancy or lactation (female patients). Serum pregnancy test to be performed within 7 days prior to study treatment start.
10. Subjects who keep a strict vegetarian diet.

Study & Design

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