NCT00539695

Brief Summary

Patients are being asked to participate in this study because treatment for their disease requires a stem cell transplant (SCT). Stem cells are the source of normal blood cells found in the bone marrow and lead to recovery of blood counts after bone marrow transplantation. With stem cell transplants, regardless of whether the donor is a full match to the patient or not, there is a risk of developing graft-versus-host disease (GVHD). GVHD is a serious and sometimes fatal side effect of SCT. GVHD occurs when the new donor stem cells (graft) recognizes that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs. How much this happens and how severe the GVHD is depends on many things, including how different the donors cells are, the strength of the drugs given in preparation for the transplant, the quality of transplanted cells and the age of the person receiving the transplant. Typically, acute GVHD occurs in the first 100 days following transplant, while chronic GVHD occurs after day 100. Acute GVHD most often involves the skin, where it can cause anywhere from a mild rash to complete removal of skin; liver, where it can anywhere from a rise in liver function tests to liver failure; and the gut, where it can cause anywhere from mild diarrhea to profuse, life-threatening diarrhea. Most patients who develop GVHD experience a mild to moderate form, but some patients develop the severe, life-threatening form. Previous studies have shown that patients who receive SCT's can have a lower number of special T cells in their blood, called regulatory T cells, than people who have not received stem cell transplants. When regulatory T cells are low, there appears to be an increased rate of severe, acute GVHD. A drug known as IL-2 (Proleukin) has been shown to increase the number of regulatory T cells in patients following stem cell transplant, and in this study investigators plan to give low dose IL-2 after transplant. This study is called a phase II study because its major purpose is to find out whether using a low-dose of IL-2 will be effective in preventing acute GVHD. Other important purposes are to find out if this treatment helps the patient's immune system recover regulatory T cells faster after the transplant. This study will assess the safety and toxicity of low-dose IL-2 given to patients after transplantation and determine whether this drug is helpful in preventing GVHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
4 months until next milestone

Results Posted

Study results publicly available

July 4, 2014

Completed
Last Updated

May 4, 2018

Status Verified

April 1, 2018

Enrollment Period

5.8 years

First QC Date

October 2, 2007

Results QC Date

April 22, 2014

Last Update Submit

April 3, 2018

Conditions

Acute Lymphoblastic LeukemiaALLAcute Myelogenous LeukemiaAMLChronic Myelogenous LeukemiaMyelodysplastic SyndromeMyeloproliferative DisorderHodgkin LymphomaNon-Hodgkin LymphomaNon-malignant Diseases Requiring Allogeneic HSCT

Keywords

Stem Cell transplantGraft verus host diseaseIL-2acute lymphoblastic leukemiaALLacute myelogenous leukemiaAMLchronic myelogenous leukemiamyelodysplastic syndromemyeloproliferative disorderHodgkin lymphomanon-Hodgkin lymphomanon-malignant diseases requiring allogeneic HSCT

Outcome Measures

Primary Outcomes (1)

  • Rate of Dose Limiting Toxicities

    Assessment of the safety and the toxicity of low-dose IL-2, administered according to the dosage described in this protocol, in this group of patients The outcome measure is the proportion of participants with dose limiting toxicities.

    6-12 weeks

Secondary Outcomes (2)

  • Rate of Severe (Grade III or IV) Acute GVHD

    Up to 12 weeks on low-dose IL-2

  • Percentage Change in CD4+ CD25+ FoxP3+ Regulatory T Cells (Tregs) From Pre to Post IL-2 Infusions

    12 weeks

Other Outcomes (1)

  • Ancillary Studies

    12 weeks

Study Arms (1)

IL2 Administration

EXPERIMENTAL

SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. Time will be measured as 'week beginning with first IL-2 injection.' T cell Induction via IL-2 to reduce GVHD

Biological: IL-2

Interventions

IL-2BIOLOGICAL

IL2 Administration: Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed \>grade I side effects to IL-2 and has not developed \>grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as 'week beginning with first IL-2 injection.

Also known as: Proleukin, Aldesleukin, Interleukin-2
IL2 Administration

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Kennedy-Nasser AA, Ku S, Castillo-Caro P, Hazrat Y, Wu MF, Liu H, Melenhorst J, Barrett AJ, Ito S, Foster A, Savoldo B, Yvon E, Carrum G, Ramos CA, Krance RA, Leung K, Heslop HE, Brenner MK, Bollard CM. Ultra low-dose IL-2 for GVHD prophylaxis after allogeneic hematopoietic stem cell transplantation mediates expansion of regulatory T cells without diminishing antiviral and antileukemic activity. Clin Cancer Res. 2014 Apr 15;20(8):2215-25. doi: 10.1158/1078-0432.CCR-13-3205. Epub 2014 Feb 26.

    PMID: 24573552DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyelodysplastic SyndromesMyeloproliferative DisordersHodgkin DiseaseLymphoma, Non-Hodgkin

Interventions

Interleukin-2aldesleukin

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Results Point of Contact

Title
Dr. Rayne Rouce
Organization
Texas Children's Hospital
rouce@bcm.edu
832-824-4716

Study Officials

  • Rayne Rouce, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics, Hem-Onc Cell & Gene

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 4, 2007

Study Start

June 1, 2007

Primary Completion

April 1, 2013

Study Completion

March 1, 2014

Last Updated

May 4, 2018

Results First Posted

July 4, 2014

Record last verified: 2018-04

Locations

US(2)