A randomised Phase II trial of Imatinib (IM) versus Hydroxychloroquine (HCQ) and IM for patients with Chronic Myeloid Leukaemia (CML) in Major Cytogenetic Response (MCyR) with residual disease detectable by quantitative polymerase chain reaction (Q-PCR) - CHOICES-CHlOroquine and Imatinib Combination to Eliminate Stem cells

Phase 1

• Conditions: Chronic Myeloid Leukaemia; MedDRA version: 15.0Level: PTClassification code 10009013Term: Chronic myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-014373-41-DE
• Lead Sponsor: Clinical Trial Center Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-05
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Male or female patients aged = 18 years old.
2. Ability to provide written informed consent prior to participation in the study and any study related procedures being performed.
3. Patient must have a fusion gene that can be monitored by Q-PCR
4. CML Chronic phase (CP) patients who have been treated with and tolerated Imatinib for at least 12 Months, have achieved at least MCyR and continue to be BCR/ABL+ by Q-PCR. Patients should be receiving a stable dose of Imatinib for 6 months prior to study entry.
5. Patients must meet the following laboratory criteria:
• ANC and Platelets need to be stable and in the range of ANC > 1.5 and platelets > 100 for =2 months
• Serum albumin >3g/dl
• AST and/or ALT =2.5 x upper limit of normal (ULN)
• Serum bilirubin =1.5 x ULN
• Serum creatinine =1.5 x ULN or 24-hour creatinine clearance =50 ml/min
• Serum potassium = lower limit of normal (LLN) with or without replacement therapy
6. ECOG Performance Status of =2
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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1. Patient who have been treated with Imatinib <12 months or patients who have changed dose in previous 6 months
2. Impaired cardiac function including any one of the following:
• Screening ECG with a QTc >450 msec
• Patients with congenital long QT syndrome
• History or presence of sustained ventricular tachycardia
• Any history of ventricular fibrillation or torsades de pointes
• Congestive heart failure (NY Heart Association class III or IV)
• Uncontrolled hypertension
3. Patients with severe GI disorder, uncontrolled epilepsy, known G6PD deficiency, known porphyria, moderate or severe psoriasis, known myaesthenia gravis or other concurrent severe and/or uncontrolled medical conditions.
4. Patients who have received chemotherapy, any investigational drug or undergone major surgery <4 weeks prior to study entry or who have not recovered from side effects of such therapy.
5. Concomitant use of any other anti-cancer therapy or radiation therapy.
6. Patients who have a pre-exisiting maculopathy of the eye.
7. Female patients who are pregnant or breast feeding or patients of reproductive potential not willing to use a double method of contraception including a barrier method (i.e. condom) during the study and 3 months after the end of the study treatment. (Patients should continue with standard contraceptive precautions beyond the study period as per Imatinib).
8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first administration of oral HCQ.
9. Male patients whose sexual partners are WOCBP not willing to use a double method of contraception including condom during the study and 3 months after the end of treatment. (Patients should continue with standard contraceptive precautions beyond the study period as per Imatinib).
10. Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.

Study & Design

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