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

March 22, 2023 updated by: Guillermo J. RUIZ-ARGÜELLES, Centro de Hematología y Medicina Interna

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Puebla, Mexico, 72530
        • Centro de Hematología y Medicina Interna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cyclophosphamide 50 mg/kg
Drug: Cyclophosphamide
Post transplant cyclophosphamide 25 mg/kg on day +3 and +4
Drug: Cyclophosphamide
Post transplant cyclophosphamide 50 mg/kg on day +3 and +4
Experimental: Cyclophosphamide 25 mg/kg
Drug: Cyclophosphamide
Post transplant cyclophosphamide 25 mg/kg on day +3 and +4
Drug: Cyclophosphamide
Post transplant cyclophosphamide 50 mg/kg on day +3 and +4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute GVHD rate
Time Frame: 6 months
Incidence of acute GVHD after HSCT
6 months
Chronic GVHD rate
Time Frame: 18 months
Incidence of chronic GVHD after HSCT
18 months
Relapse free survival
Time Frame: 12 months
Incidence of relapse of the disease after HSCT
12 months
Overall survival
Time Frame: 12 months
Patients survival after therapy
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Hematología y Medicina Interna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2023

Primary Completion (Anticipated)

March 20, 2025

Study Completion (Anticipated)

March 20, 2025

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHMI-020323-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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