Objectives
The study aimed to compare early molecular response (EMR) rates at 3 months of imatinib therapy with and without vitamin D
3
supplementation in patients newly diagnosed with chronic-phase ...chronic myeloid leukaemia (CML-CP). The secondary objective was to assess the effects of vitamin D
3
on complete haematological response (CHR) and its safety.
Design
Double-blind, placebo-controlled, exploratory randomised trial.
Setting
Tertiary care hospital in northern India.
Participants
Treatment-naive patients with chronic phase chronic myeloid leukaemia (n=62) aged >12 years were recruited from January 2020 to January 2021. Patients with progressive disease, pregnancy and hypercalcaemia were excluded.
Intervention
Oral vitamin D
3
supplementation (60 000 IU) or matched placebo was given once weekly for an initial 8 weeks along with imatinib after randomisation with 1:1 allocation ratio.
Primary and secondary outcome measures
The primary outcome was to compare EMR (defined as
BCR-ABL1
transcript level ≤10%, international scale) at 3 months. The secondary outcomes were to compare effect of the intervention on CHR, correlation of 25(OH)2D
3
levels with treatment response and safety according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Results
At baseline, 14.5% of the patients had normal vitamin D
3
levels. EMR at 3 months was attained in 24 patients (82.7%) of the vitamin D
3
group and 21 (75%) of the placebo group (OR 1.6, 95% CI 0.37 to 7.37, p=0.4). A significant difference in vitamin D
3
levels from baseline to the end of study was observed. Patients with vitamin D
3
supplementation did not achieve higher CHR in comparison with placebo (OR 1.3, 95% CI 0.25 to 7.23, p=1.0). Vitamin D3 levels were not significantly correlated with
BCR-ABL1
levels. No dose-limiting toxicities were observed.
Conclusion
Vitamin D
3
levels were low among patients with CML-CP in this study. Vitamin D
3
supplementation with imatinib therapy did not have significant effect on EMR or CHR. Further clinical trials could be undertaken to assess the effective dosage and duration of vitamin D
3
supplementation in these patients.
Trial registration number
CTRI/2019/09/021164.
Cryptosporidium infection is usually self-limiting but can be life-threatening in immunocompromised patients. It has emerged as an important cause of diarrhea in such patients worldwide. In this ...report, we describe a case of Cryptosporidium diarrhea in a child on induction therapy for acute lymphoblastic leukemia (ALL); timely diagnosis using multiplex polymerase chain reaction (PCR) led to definitive treatment and a favorable outcome in our patient.
Background:
An anaplastic large cell lymphoma (ALCL) involving the cervical spine and leading to quadriplegia is very rare.
Case Description:
A 48-year-old immunocompetent male presented with ...quadriplegia that warranted an anterior cervical corpectomy/fusion. He was previously being presumptively treated for cervical disease attributed to tuberculosis. The histopathology and immunohistochemistry revealed an ALCL that was anaplastic lymphoma kinase (ALK) negative. The patient had a favorable response to surgery followed by CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisolone) chemotherapy.
Conclusion:
ALK-negative ALCL presenting with quadriplegia due to primary involvement of cervical spine is extremely rare, but must be diagnosed and appropriately managed.
Abstract Introduction Most common source of stem cell graft for both autologous and allogenic haematopoietic transplants are peripheral blood haematopoietic progenitor stem cells. Adequate collection ...of the CD34+ cells and safety of the allogenic donor during the leukapheresis are of prime importance to an apheresis physician. Our retrospective analysis is a comparison between of two platforms namely, COBE Spectra and Amicus, for CD34+ mononuclear cell collection. Material and method The study included the data of GSCF (Granulocyte-Colony-Stimulating Factor) mobilized allogenic PBSC collections at our centre from January 2015 to June 2016. The apheresis platforms used were COBE Spectra and Amicus. Blood cell counts were done using LH750 Beckman Coulter (Florida, Miami, USA). CD45+ & CD34+ cell counts were done using BD FACS Canto-II Flow-Cytometer by ISHAGE guidelines. Results A total of 170 PBSC (100 COBE Spectra & 70 Amicus) harvests were done on 143 donors, of which 116 completed the collection in a single session and 27 required a second session. Demographic details and pre harvest peripheral blood counts for both the groups did not show any statistical differences. Amicus processed higher blood volume with higher ACD exposure and procedure time compared to COBE Spectra. Higher platelets loss was with COBE Spectra harvests with higher product volumes collection. Collection efficiency (CE2), collection ratio, CD34+ cells dose was similar on both the platforms. RBC contamination, absolute lymphocyte and monocytes counts were significantly higher with Amicus harvest product compared with COBE Spectra. A total of 14 (8.2%; citrate toxicity) adverse reactions were reported out of 170 allogenic PBSC collections. Discussion/conclusion Our study suggests that both Amicus and COBE Spectra platforms offer comparable results for allogenic PBSC collections. Amicus offers a concentrated PBSC product with lesser volume and platelets loss but higher RBC contamination.