Acute Lymphoblastic Leukaemia Clinical Trial
Official title:
Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients
Verified date | July 2020 |
Source | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be conducted to evaluate the effect of vitamin B6 and vitamin B12 in reducing the incidence and severity and delaying the onset of Vincristine Induced neurotoxicity in Acute Lymphobalstic Leukemia (ALL) patient.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 30, 2019 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - All patients, 18 years of age or older with newly diagnosed ALL going to start induction chemotherapy with Vincristine - Patients ECOG Performance Status 0 to 3 - Patients with no preexisting autonomic neuropathy - Patients with normal renal function (Serum creatinine <1.5 mg/dl) - No history of diabetes mellitus - Patients agree to participate in the study signing an informed written consent Exclusion Criteria: - Pregnant women and nursing mothers - Patients with clinical neuropathy due to diabetes mellitus and other causes like multiple sclerosis, spinal cord injury, post stroke - Patients with head neck tumors - Patients taking anticonvulsants, antidepressants, opioids, vitamin E and other neuropathic pain medication agents like topical anesthetic agents, non steroidal anti-inflammatory drugs (NSAIDs) |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Bangabandhu Sheikh Mujib Medical University | Dhaka | Shahbag |
Bangladesh | Dhaka Medical College Hospital | Dhaka |
Lead Sponsor | Collaborator |
---|---|
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Vincristine Induced neurotoxicity | Cumulative incidence at 5th week of vincristine chemotherapy | ||
Primary | Severity of Vincristine Induced neurotoxicity | Changes of severity will be assessed by COMPASS 31 on the outset of 2nd week, 3rd week, 4th week, 5th week of vincristine chemotherapy | On the outset of 1st week change in the severity of neurotoxicity on the outset of 2nd week, 3rd week, 4th week, 5th week of vincristine chemotherapy | |
Primary | Time of onset of Vincristine Induced Neurotoxicity | change in neurotoxicity status on the outset of 2nd week, 3rd week, 4th week, 5th week of vincristine chemotherapy | 1st week (baseline), change in neurotoxicity status on the outset 2nd week, 3rd week, 4th week and 5th week of vincristine chemotherapy |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01597219 -
Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers
|
Phase 2 | |
Recruiting |
NCT01619124 -
Osteonecroses in Pediatric Patients With ALL
|
N/A | |
Recruiting |
NCT01272440 -
A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
|
N/A | |
Terminated |
NCT01251809 -
Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
|
Phase 1/Phase 2 | |
Completed |
NCT01616238 -
A Study for Older Adults With Acute Lymphoblastic Leukaemia
|
Phase 2 | |
Recruiting |
NCT06037018 -
Safety Study of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies
|
Phase 1 | |
Recruiting |
NCT01949129 -
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06355583 -
Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial
|
Phase 2 |