Health TrialsbyHealthPanel

PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

ConditionGraft Versus Host Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHenry Ford Health System

About this trial

So this a Phase I study with primary objective to determine the feasibility and safety of combining post-transplant cyclophosphamide and urinary-derived human chorionic gonadotropin and epidermal growth factor (uhCG/EGF) as graft versus host disease prophylaxis in stem cell transplant with MMUDs Secondary objectives are to determine the incidence acute and chronic GVHD, progression-free survival , and overall survival

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with hematologic malignancy who have the indication for Allogeneic SCT and have no MRD or MUD.

Age 18-70 years old

Performance score of at least 80% by Karnofsky

Creatinine clearance should be >60 ml/min

Disqualifiers

Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause

Active or prior CNS leukemia, unless in complete remission for at least 2 months.

History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.

Uncontrolled infection

Trial design

Design model

Single group

Treatments tested in this trial

  • uhCG/EGF

    Drug

    PTCY for 2 doses on day +3 and +4 after stem cell transplant followed by uhCG/EGF subcutaneously on day +7, +9 and +11 post stem cell transplant

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: PTCY and uhCG/EGFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MTD

The maximum tolerated dose

Time frame
day+30 post SCT
2

Incidence and severity of dose limiting toxicity (DLTs)

The overall incidence and severity of DLTs for uhCG/EGF

Time frame
day+30 post SCT

Secondary outcomes

1

acute GVHD

Cumulative incidence of acute GVHD

Time frame
till day +100 post SCT
2

Chronic GVHD

Cumulative incidence of chronic GVHD

Time frame
one year post SCT
3

Overall survival

Death from any cause will be considered an event. Surviving patients will be censored at the time of last follow up.

Time frame
one year post SCT
4

Disease free survival

Survival following allogeneic SCT without relapse or progression. Relapse or progression of disease, or death are considered events

Time frame
one year

Other outcomes

Sponsors and contacts

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

Henry Ford Health System

Lead sponsor

Source ClinicalTrials.gov
Apply now