ClinicalTrials.gg
Status unknownNCT05780554Updated Mar 23, 2023

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

An interventional study of Cyclophosphamide and Cyclophosphamide in Graft Vs Host Disease, sponsored by Centro de Hematología y Medicina Interna. Status unknown at 1 site in Mexico. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by Centro de Hematología y Medicina Interna · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Non-randomized
Sex
All
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Study 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.

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Conditions studied

  • Graft Vs Host Disease

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03

In context

Graft vs Host Disease

815 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's planned enrollment of 42 is above the median of 35 across 643 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Centro de Hematología y Medicina Interna is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Active comparator
    Cyclophosphamide 50 mg/kg

    Drug: Cyclophosphamide

  • Experimental
    Cyclophosphamide 25 mg/kg

    Drug: Cyclophosphamide

Interventions

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What researchers measure

Primary outcomes

  1. Acute GVHD rate

    Incidence of acute GVHD after HSCT

    Time frame: 6 months

  2. Chronic GVHD rate

    Incidence of chronic GVHD after HSCT

    Time frame: 18 months

  3. Relapse free survival

    Incidence of relapse of the disease after HSCT

    Time frame: 12 months

  4. Overall survival

    Patients survival after therapy

    Time frame: 12 months

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Study locations

1 site
  • Centro de Hematología y Medicina Interna
    Puebla City, 72530, Mexico
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References and documents

Publications

  • 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. PubMed 37530697 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Mar 2025, 24 months after the start.

Of 33 interventional studies with no phase under Graft vs Host Disease, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 89. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2023
First posted
Mar 22, 2023
StartActual
Mar 10, 2023
Primary completionEst.
Mar 20, 2025
CompletionEst.
Mar 20, 2025
Last update
Mar 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05780554
Lead sponsor
Centro de Hematología y Medicina Interna
Responsible party
Guillermo J. RUIZ-ARGÜELLES (General director, Centro de Hematología y Medicina Interna) — Principal investigator
First posted
Mar 22, 2023
Start date
Mar 10, 2023
Primary completion
Mar 20, 2025 (estimated)
Completion
Mar 20, 2025 (estimated)
Last update
Mar 23, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cyclophosphamide

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