Bone Marrow Transplant Clinical Trials

Clinical trials related to Bone Marrow Transplant Procedure

Phase II Trial of Reduced Dose Post Transplant Cyclophosphamide After Haploidentical Hematopoietic Stem Cell Transplant in Hematological Malignancies

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients age ≥ 18 years

• ECOG performance score of 0 or 1

Locations
Other Locations
India
Advanced Centre for Treatment, Research and Education in Cancer
RECRUITING
Navi Mumbai
Advanced Centre for Treatment, Research and Education in Cancer
NOT_YET_RECRUITING
Navi Mumbai
Contact Information
Primary
Dr Sachin Punatar, MBBS MD DM medical oncology
drsachin_punatar@yahoo.in
09833445041
Backup
Dr.Akanksha Chichra, FNB,,DNB Pediatric oncology
akanksha7@hotmail.com
Time Frame
Start Date: 2025-03-26
Estimated Completion Date: 2028-11-12
Participants
Target number of participants: 20
Treatments
Experimental: Low dose cyclosphosphamide
Single Arm study and cyclophosphamide at a lower dose (25 mg/kg x 2 days)
Related Therapeutic Areas
Sponsors
Collaborators: Indian Council of Medical Research
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov