Recruiting PHASE3 Acute Graft-versus-host Disease

New treatment option for Acute Graft-versus-host Disease

Official title Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases

ClinicalTrials.gov ID: NCT06294691

What this study is testing

What it's testing
To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 12 to 60

You may be able to join if

  • Definite diagnosis of malignant hematologic disease before transplantation, age 12-60 years old, gender is not limited, race is not limited;
  • Patients who are proposed to receive allo-PBSCT for the first time;
  • Eastern Cooperative Oncology Group (ECOG) score 0-2;
  • No serious organ failure and active infection;
  • Voluntary open assigned by chance controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after...

You likely can't join if

  • Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;
  • Pregnant patients;
  • Patients and/or authorized family members who refuse to undergo an open assigned by chance controlled study to observe whether the time of stem cell...
  • Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety...
  • Participants in other clinical studies that may affect aGVHD within 3 months;
  • Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the...
See the full eligibility criteria
Who can join
  • Definite diagnosis of malignant hematologic disease before transplantation, age 12-60 years old, gender is not limited, race is not limited;
  • Patients who are proposed to receive allo-PBSCT for the first time;
  • Eastern Cooperative Oncology Group (ECOG) score 0-2;
  • No serious organ failure and active infection;
  • Voluntary open assigned by chance controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;
  • Each subject must sign an informed consent form (ICF) indicating that he/ she understands the purpose and procedures of the study and is willing to participate in the study; in view of the patient's condition, if the...
What rules you out
  • Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;
  • Pregnant patients;
  • Patients and/or authorized family members who refuse to undergo an open assigned by chance controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;
  • Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at unnecessary risk; drug-dependent...
  • Participants in other clinical studies that may affect aGVHD within 3 months;
  • Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the examination and treatment due to financial and other issues).

The study team makes the final eligibility decision.

Where it's taking place

  • Hefei, Anhui, China
  • Beijing, Beijing Municipality, China
  • Zhengzhou, Henan, China
  • Wuhan, Hubei, China
  • Shanghai, Shanghai Municipality, China
  • Hangzhou, Zhejiang, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 12 years to 60 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.