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To Study Lower Dose of Cyclophosphamide After Stem Cell Transplant for Blood Cancers
Sponsor: Tata Memorial Centre
Summary
Cyclophosphamide is the name of a medicine given to prevent graft-versus-host-disease (GVHD) after half-matched transplant. This medicine is given on the 3rd and 4th day after stem cell transplant. The standard dose of this medicine is 50 mg per kg of the patient's weight given on the 3rd and the 4th day. However, using this medicine at this dose of 50 mg / kg for 2 days is associated with certain problems such as susceptibility to infections and delay in the recovery of the immune system after stem cell transplant. Therefore, several research groups across the world have tried to reduce the dose of cyclophosphamide that is used. These groups have tried reducing the dose from 50 mg per kg to 25-40 mg per kg. These studies have shown that the reduced dose cyclophosphamide is equally effective in preventing GVHD. However, these studies are carried out on small numbers of patients and further studies are essential to confirm whether reduced dose of cyclophosphamide is equally effective. In this study, we will use cyclophosphamide at a lower dose (25 mg/kg x 2 days) and see if the lower dose results in equal efficacy but lesser toxicities This is a single-arm study. All participants will receive the same treatment; there is no comparison group. Participants will: Adults (age ≥18) undergoing haploidentical stem cell transplant for blood cancers Receive low-dose cyclophosphamide (25 mg/kg/day) on Day 3 and Day 4 after transplant Also receive standard GVHD preventive medicines (calcineurin inhibitor and mycophenolate) Undergo regular blood tests, immune system monitoring, and GVHD assessments Have immune cell and cytokine profiles analyzed through blood samples
Official title: Phase II Trial of Reduced Dose Post Transplant Cyclophosphamide After Haploidentical Hematopoietic Stem Cell Transplant in Hematological Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-03-26
Completion Date
2028-11-12
Last Updated
2026-07-22
Healthy Volunteers
No
Interventions
Cyclophosphamide
Post-transplant Immunosuppression: ● GvHD prophylaxis regimen will consist of two doses of cyclophosphamide on D+3 and D+4 at 25mg/kg/day (that is half of the usual standard dose) with calcineurin inhibitor and mycophenolate mofetil / mycophenolate sodium. Mesna will be given with cyclophosphamide (this is standard of care). The use of calcineurin inhibitors and mycophenolate mofetil / mycophenolate sodium will be as per standard practice. Administration of study treatments * Hydration and MESNA * Adequate intravenous hydration with normal saline will be started at least 4 hours prior to cyclophosphamide, and will be continued till 24 hours post completion of 2nd dose of cyclophosphamide as per standard institutional practice. * Mesna will be administered as a continuous infusion starting from Day+3 till 24 hours after the second dose of PTCy. * Cyclophosphamide * Cyclophosphamide would be administered on D+3 and D+4 \[first dose starting between 60 - 72 hrs after stem cell infusion\]
Locations (2)
Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, Maharashtra, India
Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, Maharashtra, India