Clinical Trials

The following are Haematology Clinical trials in Malaysia :

Centre Name
Status
Phase
Study Title
Study Design
Inclusion Criteria
Start Date
Hosp P PinangRecruitingIIIChronos 3 study on safety and efficacy of iv copanlisib in combination with rituximab in pts with relapsed indolent B-NHLRandomised double blind placebo controlledRelapsed FL, MZL, WM, SLL
At least 1 prior line of treatment
At least 1 year from last Rituximab containing chemo exposure.
At least 6 months from ritux exposure if unfit to receive further chemo due to age or comorbidities
Hosp P PinangRecruitingIIICommodore study- Gilteritinib vs standard AML therapy in Flt3 AMLRCTFlt 3+AML in 1st relapse or refractory disease9/15/2017
Hosp P PinangRecruitingIIIHAVEN-5 study to evaluate efficacy, safety and PK of prophylactic emicizumab vs no prophylaxis in hemophilia A pts with or without inhibitorsRandomised open labelHemophilia A with or without inhibitors
At least 5 bleeds in 24 weeks prior to screening
Hospital USMRecruitingIIIA Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of copanlisib in combination with rituximab in patients with relapsed indolent B-cell non-Hodgkin’s lymphoma (iNHL)- CHRONOS-3Double blind randomised controlled trial1. Histologically confirmed diagnosis of CD20 positive iNHL, with histological
subtype limited to:
• Follicular lymphoma (FL) grade 1-2-3a
• Small lymphocytic lymphoma (SLL) with absolute lymphocyte count <5x109/L at the time of
diagnosis and at study entry
• Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
• Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal) sent must be obtained before any
study specific procedure

2. Patients must have relapsed after at least 1 prior line of therapy, including
rituximab. A previous regimen is defined as one of the following: at least 2
months of single-agent therapy; at least 2 consecutive cycles of
polychemotherapy; autologous transplant; radioimmunotherapy. Previous
exposure to PI3K is acceptable provided there is no resistance

3. Non-WM patients must have at least one bi-dimensionally measurable lesion
(which has not been previously irradiated) according to the Lugano
Classification.

4. Patients affected by WM who do not have at least one bi-dimensionally
measurable lesion in the baseline radiologic assessment must have
measurable disease, defined as presence of immunoglobulin M (IgM)
paraprotein with a minimum IgM level ≥ 2 x upper limit of normal (ULN) and
positive immunofixation test.

5. Male or female patients ≥ 18 years of age

6. ECOG performance status ≤ 2 (ECOG: Eastern Cooperative Oncology Group)

9. Life expectancy of at least 3 months

10. Availability of fresh tissue and/or archival tumor tissue at Screening
3/2/2017
Hospital Queen Elizabeth 1RecruitingIIA multi-center,randomised, open-label,controlled trial evaluating the efficacy and safety of prophylactic administration of Concizumab in Haemophilia A and B patients with inhibitors. multi-center,randomised (2:1) , open-label,controlled trial, aiming to evaluate the efficacy and safety of prophylactic administration of Concizumab in Haemophilia A and B patients with inhibitors.*Informed consent ontained before any trial related activities
*Male haemophilia A or B patients with inhibitors aged > 18 years at the time of signing informed consent.
*Patients currently in need of treatment with bypassing agents.
Hospital Queen Elizabeth 1RecruitingIIIA phase 3,randomized, open-label,active-controlled study of ALXN1210 versus eculizumab in complement inhibitor-naive adult patients with paroxysmal nocturnal hemoglobinuria(PNH)Phase 3, open-label,randomized,active controlled, multicenter study to evaluate the safety and efficacy of ALXN1210 versus eculizumab administered by intravenous(IV) infusion to adult patients with PNH who are naive to complement inhibitor treatment. Enroll approximately 214 patients.*Male or female, 18 years of age or older at the time of consent.
*Documented diagnosis of PNH,confirmed by high-sensitivity flow cytometry evaluation.
*Presence of 1 or more of the following PNH-related signs or symptoms within 3 months of screening : fatigue,hemoglobinuria,abdominal pain, shortness of breath,anemia(hemoglobin <10g/dL),history of major adverse vascular event,dysphagia,or erectile dysfunction; history of pRBC transfusion due to PNH.
*LDH level >1.5 x ULN at screening
2/7/2017
Hospital Queen Elizabeth 1RecruitingIIIPhase 3, prospective, randomized , multi-center clinical study comparing the safety and efficacy of BAX 855 following PK-guided prophylaxis targeting two different FVIII trough levels in subjects with severe Hemophilia AThis study is a Phase 3, prospective, randomized,open-label, multicenter study to compare the safety and efficacy of a PK-guided BAX 855 treatment regimen targeting 2 different FVIII trough levels in approximately 116 subjects with severe hemophilia A to have 96 evaluable (48 per treatment arm 12-65 years old at the time of screening.
 Severe hemophilia A (FVIII clotting activity <1%) as confirmed by central laboratory or by historically documented FVIII clotting activity perfomed by a certified clinical laboratory, optionally supported by a FVIII gene mutation consistent with severe hemophilia A.
 Previously treated with plasma-derived FVIII concentrates or recombinant FVIII for >150 documented EDs
 Subject is either receiving on-demand treatment or prophylactic treatment and had an annual bleeding rate of >2 documented and treated during the past 12 months
 Karnofsky performance score of >60 at screening.
 AST & ALT <2.5x ULN
 BILT <1.5 & creatinine <1.5 x ULN
 Suitable for oral administration of study drug.

Hospital Queen Elizabeth 1RecruitingIIIA phase 3, Double-Blind, Randomized Placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept(ACE-536) versus placebo in adults who require regular red blood cell transfusions due to beta (β)- ThalassemiaPhase 3, multicenter,randomized, double-blind,placebo-controlled, study to compare the efficacy and safety of luspatercept plus BSC versus placebo plus BSC in adult subjects with regularly transfused (β)- thalassemia. It is planned to randomize approximately 300 subjects at 2:1 ratio of luspatercept plus BSC versus placebo plus BSC. Male or female >18 years of age at the time of signing informed consent.
 Regularly transfused, defined as : 6-20 RBC units* in the 24 weeks prior to randomization and no transfusion-free period for >35 days during that period.
 ECOG score of 0 or 1
Hospital Queen Elizabeth 1RecruitingIIIPhase 3 Open-label, Multicenter, Randomized study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia(AML) with FLT3 MutationPhase 3, open-label, multicenter, randomized study to compare the efficacy and safety of ASP2215 therapy to salvage chemotherapy in FLT3-mutated AML subjects who are refractory to or have relapsed after first-line AML therapy. 318 subjects will be randomized in a 1:1 ratio to receive ASP2215 or salvage chemotherapy. Consider an adult according to local regulation(>18yrs old in China) at the time of signing form.
 Diagnosis of primary AML or AML secondary to myelodysplastic syndrome(MDS)
 Subject is refractory to or relapsed after first-line AML therapy (with or without HSCT)
 Positive for FLT3 mutation in bone marrow or whole blood.
 ECOG : <2
Hospital Queen Elizabeth 1RecruitingIIIA phase 3, randomized, double –blind, placebo-controlled study evaluating the efficacy and safety of copanlisib in combination with rituximab in patients with relapsed indolent B-cell non-Hodgin’s lymphoma(iNHL)- CHRONOS-3Randomized,double-blind, placebo-controlled,two-arm, phase 3 study to evaluate efficacy and safety of copanlisib in combination with rituximab, in comparison to placebo in combination with rituximab, in patients with relapsed iNHL Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:

i. Follicular lymphoma(FL) G1-2-3a
ii. Small lymphocytic lymphoma (SLL) with absolute lympocyte count ,5x10^9/L at the time of diagnosis and at study entry.
iii. Lymphoplasmacytoid lymphoma/Waldenstrom macroglobinuria
iv. Marginal zone lymphoma

 Male or female patient >18 years of age.
 ECOG: < 2
 Left ventricular ejection fraction > 45%
University Malaya Medical CentreRecruitingIIIChronos 3 study on safety and efficacy of iv copanlisib in combination with rituximab in pts with relapsed indolent B-NHRandomised double blind placebo controlledrelapsed refractory indolent B cell lymphoma
University Malaya Medical CentreRecruitingIIICommodore study- Gilteritinib vs standard AML therapy in Flt3 AMLrandomised controlled relapsed refractory AML with FLT3 inhibitor
Hospital Sultanah Aminah, Johor BharuRecruitingIIIPhase 3 Open-label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotheraphy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)Open-label, Randomized1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study related procedures (including withdrawal of prohibited medication, if applicable).
2. Subject is considered an adult according to local regulation at the time of signing informed consent.
3. Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification (2008) as determined by pathology review at the treating institution.
4. Subject is refractory to or relapsed after first-line AML therapy (with or without HSCT).
• Refractory to first-line AML therapy is defined as: Subject did not achieve CR/CRi/CRp under initial therapy. A subject eligible for standard therapy must receive at least one cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A subject not eligible for standard therapy must have received at least one complete block of induction therapy seen as the optimum choice of therapy to induce remission for this subject as per Investigator’s assessment.
• Untreated first hematologic relapse is defined as: Subject must have achieved a CR/CRi/CRp (criteria as defined by [Cheson et al, 2003] with first line treatment and has hematologic relapse.
5. Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by central lab. In the Investigator’s opinion, a subject with rapidly proliferative disease and unable to wait for the central lab results can be enrolled based on local test performed after completion of the last interventional treatment. Subjects can be enrolled from a local test result if they have any of the following FLT3 mutations: FLT3 ITD, FLT3 TKD/D835 or FLT3 TKD/I836
6. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
7. Subject is eligible for pre-selected salvage chemotherapy according to Investigator assessment.
8. Subject must meet the following criteria as indicated on the clinical laboratory tests: • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit normal (ULN) • Total serum bilirubin ≤ 1.5 x ULN • Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate (eGFR) of > 50 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
9. Subject is suitable for oral administration of study drug.
10.Subject agrees not to participate in another interventional study while on treatment.
10/16/2017
Ampang hospitalRecruitingIA phase 1b study of subcutaneous administered APL-2 in subjects with PNH (PADDOCK study)Phase 1b, Open labelPNH patients >18 years old with last blood transfusion within 12 months12/12/2017
Ampang HospitalRecruitingIIIProphylaxis and treatment of Bleeds in previously turoctocog alfa pegol (N8-GP) treated patients with severe haemophilia A (Pathfinder 8)Phase 3, open label, non-randomisedOngoing participation in Pathfinder 2 or Pathfinder 5 study5/4/2018
Ampang HospitalRecruitingIIIHemostatic efficacy of PEGylated Factor VIII (BAX 855) in previously untreated patients (PUPs) <6 years with severe haemophilia APhae 3, open labelPUPs < 6years8/10/2015
Ampang HospitalRecruitingIISafety and Efficacy of OMS721 in Adults with Thrombotic MicroangiopathiesPhase 2, Cohort studyPersistent HSCT-associated TMA at least 2 weeks following modification or discontinuation of calcineurin inhibitor or at least 30 days after transplant3/1/2016