Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age1-75
SponsorHospital Israelita Albert Einstein

About this trial

This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and Women of Any Age

Indication for an HSCT without matched sibling donor

Have a matched unrelated donor (HLA 10 x 10 or 9 x 10)

Hematological malignancy

Disqualifiers

Acute leukemias not in complete response (that is > 5% blast in the bone marrow)

Chemorefractory lymphoproliferative disease

Active uncontrolled infection

HCT-CI > 3

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cyclophosphamide

    Drug

    Cyclophosphamide 1000 mg/flask

  • ATG

    Drug

    Antihuman T-Lymphocyte Immune Globulin 25 mg/flask

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Post CyclophosphamideExperimental treatment 1 intervention
Group B: Thymoglobulin (ATG)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

Time to last follow-up or death

Time frame
4 years

Secondary outcomes

1

Progression free survival

Time until last follow-up, death or disease relapse

Time frame
4 years
2

Acute Graft Versus Host Disease

Time until acute GvHD development

Time frame
4 years
3

Chronic Graft Versus Host Disease

Time until chronic GvHD development

Time frame
4 years
4

Treatment Related Mortality

Time until death related to HSCT complications

Time frame
4 years

Other outcomes

1

Graft Failure Incidence

ANC \< 500/microL after 42 days after graft infusion

Time frame
2 years
2

Time Until Neutrophil Engraftment

Time to ANC \> 500/microL for three consecutive days

Time frame
2 years
3

Time Until Platelet Engraftment

Time to platelet count \> 50,000/microL, without transfusion in the last 7 days

Time frame
2 years
4

Immunological Reconstitution

Total lymphocyte count as well as its subsets (CD4, CD8, CD19, CD56)

Time frame
Days +60, +100 and +180

Sponsors and contacts

Click on the lead sponsor to view all of their trials.