Low Dose IL-2, Hematopoietic Stem Cell Transplantation, IL2 for GVHD

Plain-language summary

This study looks at the role of low-dose IL-2 treatment in preventing graft-versus-host disease (GVHD) in patients undergoing hematopoietic stem cell transplantation. People from birth to age 70 who needed an allogeneic transplant for conditions such as acute or chronic leukemia, lymphoma or myelodysplastic syndrome could take part. The study was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Baylor College of Medicine

Intervention

IL-2

Start date

6/1/2007

Estimated completion

3/1/2014

Countries

United States

Related genes

Locations

• Houston, United States
• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

INCLUSION CRITERIA:

INCLUSION CRITERIA FOR INITIAL STUDY ENROLLMENT:

Patients will be eligible for initial enrollment on this study as long as they meet the following criteria:

* Diagnosis of acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, myeloproliferative disorder, Hodgkin lymphoma, non-Hodgkin lymphoma or non-malignant disease requiring allogeneic HSCT
* Birth to age 70 years of age
* Study entry consent is signed and faxed to Research Coordinator

INCLUSION CRITERIA AT TIME OF IL-2 ADMINISTRATION:

* At least day +7 post transplant
* Less than or equal to 30 days post transplant
* Lansky or Karnofsky score greater than or equal to 50%
* Total bilirubin less than or equal to 1.5mg/dL
* Alanine aminotransferase level (ALT) less than or equal to five times normal, serum direct bilirubin less than or equal to 1.5mg/dL, albumin greater than or equal to 3.0gm/dL
* Serum creatinine less than three times normal or creatinine clearance greater than 80mg/min/1.73m2
* Ensure that informed consent signed and faxed to Research Coordinator

EXCLUSION CRITERIA:

EXCLUSION CRITERIA AT TIME OF IL-2 ADMINISTRATION:

Patients will be ineligible to receive IL-2 injections if any of the following is true:

* Active, acute GVHD greater than or equal to grade II
* Serious, active bacterial, fungal or viral infection (i.e. intensive care)
* Clinical Signs of severe pulmonary dysfunction
* Clinical Signs of sever cardiac dysfunction
* Receiving corticosteroids as GVHD treatment
* Hypersensitivity or allergy to IL-2