Post-transplantation Cyclophosphamide in Haploidentical S... | NCT05780554

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

NCT05780554

Sponsor

Centro de Hematología y Medicina Interna

Status

Unknown status

Last Update Posted

Mar 23, 2023Actual

Enrollment

42Estimated

Phase

Not Applicable

Conditions

Graft Vs Host Disease

Interventions

Cyclophosphamide
Cyclophosphamide

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2023Actual

Primary Completion Date

Mar 20, 2025Estimated

Completion Date

Mar 20, 2025Estimated

First Submitted Date

Mar 10, 2023

First Submission Date that Met QC Criteria

Mar 10, 2023

First Posted Date

Mar 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2023

Last Update Posted Date

Mar 23, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guillermo J. RUIZ-ARGÜELLES, General director, Centro de Hematología y Medicina InternaPrincipal Investigator

Lead Sponsor

Centro de Hematología y Medicina InternaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cyclophosphamide 50 mg/kg	Active Comparator		Drug: Cyclophosphamide
Cyclophosphamide 25 mg/kg	Experimental		Drug: Cyclophosphamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclophosphamide	Drug	Post transplant cyclophosphamide 25 mg/kg on day +3 and +4	Cyclophosphamide 25 mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro de Hematología y Medicina Interna		Puebla City		72530	Mexico

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37530697	Derived	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.

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated