NCT05780554

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 10, 2023

Last Update Submit

March 22, 2023

Conditions

Graft Vs Host Disease

Outcome Measures

Primary Outcomes (4)

  • Acute GVHD rate

    Incidence of acute GVHD after HSCT

    6 months

  • Chronic GVHD rate

    Incidence of chronic GVHD after HSCT

    18 months

  • Relapse free survival

    Incidence of relapse of the disease after HSCT

    12 months

  • Overall survival

    Patients survival after therapy

    12 months

Study Arms (2)

Cyclophosphamide 50 mg/kg

ACTIVE COMPARATOR
Drug: Cyclophosphamide

Cyclophosphamide 25 mg/kg

EXPERIMENTAL
Drug: Cyclophosphamide

Interventions

CyclophosphamideDRUG

Post transplant cyclophosphamide 25 mg/kg on day +3 and +4

Cyclophosphamide 25 mg/kg

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Hematología y Medicina Interna

Puebla City, 72530, Mexico

Location

Related Publications (1)

  • Olivares-Gazca JC, Pastelin-Martinez ML, Montes-Robles MA, Gallardo-Perez MM, Hernandez-Flores EJ, Robles-Nasta M, Sanchez-Bonilla D, Ruiz-Delgado GJ, Ruiz-Arguelles GJ. Can doses of post-transplantation cyclophosphamide in haploidentical stem cell allografts be reduced? Hematology. 2023 Dec;28(1):2242176. doi: 10.1080/16078454.2023.2242176.

    PMID: 37530697DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General director

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 22, 2023

Study Start

March 10, 2023

Primary Completion

March 20, 2025

Study Completion

March 20, 2025

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations

ME(1)