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Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg

Primary Purpose

Graft Vs Host Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Cyclophosphamide
Cyclophosphamide
Sponsored by
Centro de Hematología y Medicina Interna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Graft Vs Host Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Candidates to receive a Haplo-HSCT (myeloid acute leukemia, lymphoid acute leukemia, myelodysplastic syndrome, multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma, myeloid chronic leukemia, medullary hypoplasia, non-malignant hematologic diseases). Patients able to travel to and remain in Puebla, México during a 4-week period, accompanied by a caregiver. Exclusion Criteria: Patients who refuse to sign the consent form. Latent infection. Hepatic, cardiac or bronchopulmonary symptomatic diseases Abnormalities on previous clinical hematological appointments, considered as contraindication. Positive serology for HIV, VHB, VHC

Sites / Locations

  • Centro de Hematología y Medicina Interna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cyclophosphamide 50 mg/kg

Cyclophosphamide 25 mg/kg

Arm Description

Outcomes

Primary Outcome Measures

Acute GVHD rate
Incidence of acute GVHD after HSCT
Chronic GVHD rate
Incidence of chronic GVHD after HSCT
Relapse free survival
Incidence of relapse of the disease after HSCT
Overall survival
Patients survival after therapy

Secondary Outcome Measures

Full Information

First Posted
March 10, 2023
Last Updated
March 22, 2023
Sponsor
Centro de Hematología y Medicina Interna
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1. Study Identification

Unique Protocol Identification Number
NCT05780554
Brief Title
Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg
Official Title
Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
March 20, 2025 (Anticipated)
Study Completion Date
March 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro de Hematología y Medicina Interna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Allogeneic hematopoietic cell transplantation (HSCT) is a worldwide recognized therapy for several hematologic malignancies; a modality extensively used around the world due to its effectivity; however, an HLA-matched sibling or unrelated donor is not always available, because of diverse factors such as: ethnic minorities and multiethnic families, socio-economic status, among others. This problem has led to an expansion of the donor pool to include alternative donor sources such as HLA-haploidentical (Haplo) relatives, HLA-mismatched unrelated donors, and HLA-matched or mismatched cord blood. In the Hematology and Internal Medicine Center of Clinica Ruiz, we have seen that 50% reduced doses of post-transplantation cyclophosphamide (25 mg/Kg) on days +3 and +4 have a favorable effect on patient's survival rates compared to the full 50 mg/Kg doses. Haplo-HSCT can be conducted safely on an outpatient basis, using peripheral blood stem cells, this leading into substantial decreases in the costs. Outpatient-based Haplo-HSCT has turned into the solution of the HSCT most frequent problems in low- and middle-income countries (LMIC): Cost and donor availability. The high dose administration of PT-Cy after transplant can lead into hematological and cardiac, toxicities. There is preliminary information about diminished doses of PTCy, might being equally effective in the prevention of GVHD and substantially less toxic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Vs Host Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyclophosphamide 50 mg/kg
Arm Type
Active Comparator
Arm Title
Cyclophosphamide 25 mg/kg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Post transplant cyclophosphamide 25 mg/kg on day +3 and +4
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Post transplant cyclophosphamide 50 mg/kg on day +3 and +4
Primary Outcome Measure Information:
Title
Acute GVHD rate
Description
Incidence of acute GVHD after HSCT
Time Frame
6 months
Title
Chronic GVHD rate
Description
Incidence of chronic GVHD after HSCT
Time Frame
18 months
Title
Relapse free survival
Description
Incidence of relapse of the disease after HSCT
Time Frame
12 months
Title
Overall survival
Description
Patients survival after therapy
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Candidates to receive a Haplo-HSCT (myeloid acute leukemia, lymphoid acute leukemia, myelodysplastic syndrome, multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma, myeloid chronic leukemia, medullary hypoplasia, non-malignant hematologic diseases). Patients able to travel to and remain in Puebla, México during a 4-week period, accompanied by a caregiver. Exclusion Criteria: Patients who refuse to sign the consent form. Latent infection. Hepatic, cardiac or bronchopulmonary symptomatic diseases Abnormalities on previous clinical hematological appointments, considered as contraindication. Positive serology for HIV, VHB, VHC
Facility Information:
Facility Name
Centro de Hematología y Medicina Interna
City
Puebla
ZIP/Postal Code
72530
Country
Mexico

12. IPD Sharing Statement

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Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg

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