Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue
Conditions
Interventions
Intervention1: Tablet Rifaximin: Tab Rifaximin 200 mg will be given orally twice daily from day -8 to day +60 of allogeneic stem cell transplant in acute leukemia patients. This will be in addition to
Sponsors
Lady Tata Memorial Trust
Eligibility
Inclusion criteria
Inclusion criteria: a. Patients with acute leukemia and planned for aHSCT. b. Patients with age more than 18 years ( > 18 years). c. Patients who give written informed consent. d. Underlying hematologic malignancy in which aHSCT is indicated. e. ECOG performance status 0, 1 or 2 (on day of enrolment). f. Adequate Liver function test with serum SGOT/AST and SGPT/ALT
Exclusion criteria
Exclusion criteria: a. Known hypersensitivity to rifaximin or other rifampicin antimicrobial agents b. Patients on therapy with antibiotics for bacterial or fungal infections on day of enrolment (Except for azole prophylaxis for fungal infections, acyclovir prophylaxis for herpes and cotrimoxazole prophylaxis for pneumocystis jerovecii infections, which are permissible). c. Patients with current or past history of inflammatory bowel disease d. Patients with history of major bowel resection or patients with colostomy. e. Use of rifampicin or rifaximin in last 1 month before enrolment. f. Any serious medical condition or psychiatric illness that would prevent the subject from signing the informed consent form or in opinion of the investigator make the patient unfit for enrolment in the trial. g. Patients on the following P-glycoprotein inhibitors at time of enrolment: Verapamil, ketoconazole and itraconazole will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the impact of rifaximin on gut microbial alpha diversity as measured by inverse simpson index (ISI) and compare it with controls.Timepoint: 15 days post transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the incidence of severe (grade III/IV) acute graft versus host disease (aGVHD) in patients who receive peri-transplant rifaximin with that in control arm.Timepoint: 1 year post transplant;To determine impact of gut decontamination with rifaximin on incidence of multidrug resistant (MDR) sepsis and usage of higher antibiotics (e.g. Carbapenems, colistin, tigecycline, ceftazidime avibactum and ceftriaxone-sulbactam EDTA) in first 6 months post BMTTimepoint: 6 months post transplant;To determine non relpase mortality (NRM) at 1 year post transplant in patients who receive peritransplant transplant rifaximin and compare it with controls.Timepoint: 1 year post transplant;To determine the impact of rifaximin induced gut manipulation on immune reconstitution, T cell repertoire post transplant and cytokine profile.Timepoint: 1 year post transplant;To use single cell transcriptomics (SCT) to identify immune cell profile in gut biopsies post allogeneic stem cell transplant in order to get insights into the impact of microbiome on gut immunity which may be responsible for aGVHD.Timepoint: 1 year | — |
Countries
India
Contacts
Public ContactDr Anant Gokarn
Tata Memorial Centre
Outcome results
None listed