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Acute Myelogenous Leukemia (AML)NCT00088543

Thymoglobulin to Prevent Acute Graft vs. Host Disease (GvHD) in Patients With Acute Lymphocytic Leukemia (ALL) or Acute Myelogenous Leukemia (AML) Receiving a Stem Cell Transplant

A study testing Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] in people with Acute Myelogenous Leukemia (AML) and Acute Lymphocytic Leukemia (ALL), run by Genzyme, a Sanofi Company at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study involves the use of a drug called Thymoglobulin, which is approved in the USA to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection. Thymoglobulin is not approved for the treatment or prophylaxis of graft versus host disease in bone marrow transplantation. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
14 sitesin 2 countries
Study dates
Mar 2004to Apr 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subject has an HLA-A, -B and -DRB1 identical related donor and must be fully matched at Class II. A high resolution molecular HLA typing (at least 4 digits) is mandatory for HLA Class II and optional for HLA Class I
  • Subject has confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) with acute myeloid leukemia (including secondary leukemia) in first complete remission (CR2) or acute lymphoid in CR1 or CR2.
  • Subject is >= 18 and <= 55 years of age.
  • Subject is receiving a myeloablative-conditioning regimen
  • Men and women of childbearing age potential agree to practice an acceptable and reliable form of contraception during the study. Women must not be lactating or pregnant, and must have a negative serum pregnancy test.
  • Subject has been fully informed and has signed an IRB-approved informed consent form.
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  • Subject is willing and able to follow study procedures for the 6 months post-transplant.
  • The subject must be serologically negative for human immunodeficiency virus (HIV).
  • Subject agrees to be followed for possible long-term safety outcomes for up to 12 months post-transplant.
  • Subject has an ECOG performance score of 0-2.
  • Subject has a creatinine of < 2.0mg/dL or creatinine clearance of > 50mL/min.
  • Subject has an ejection fraction of >= 40%
  • Subject has a serum bilirubin of < 2mg/dL.

Who cannot join

  • Subject is receiving fludarabine, a non-myeloablative regimen, or other purine analogues as part of the conditioning regimen.
  • Subject is receiving an ex vivo engineered or processed graft (CD34+ enrichment, T-cell depletion, etc.)
  • Subject has documented uncontrolled central nervous system (CNS) disease.
  • Subject is expected to receive or has received methotrexate for GvHD prophylaxis.
  • Subject has alanine aminotransferase (ALT)or aspartate aminotransferase (AST) level of > 3x the upper limit of normal range within 3 weeks prior to transplant.
  • Subject has used any experimental agent within 30 days prior to the date of signing the informed consent.
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  • Subject is receiving or has received a bone marrow transplant from a donor who has positive serology for HIV, hepatitis B virus(HBV), hepatitis C virus (HCV) or syphilis.
  • Subject has a known contraindication to administration of rabbit anti-thymocyte globulin.
  • Subject is currently abusing drugs or alcohol or, in the opinion of the Investigator, is at high risk for poor compliance.
  • Subject, who in the opinion of the Investigator, has significant medical or psychological problems that warrants exclusion. Examples of significant problems include, but are not limited to, morbid obesity or severe cardiac disease.

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

United States12 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • University of Alabama-Birmingham Hospital

    Birmingham, Alabama, 35249

  • Massachusetts General Hospital Cox Bldg Room 640

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute Dana 1B11

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center KS121

    Brookline, Massachusetts, 02215

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Shands at the University of Florida, Division of Hematology/Oncology

    Gainesville, Florida, 32610

  • Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • UCLA Medical Center

    Los Angeles, California, 90095

  • The Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

Canada2 sites

  • Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Hospital, University Health Network

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Pilot Trial of Two Dose Levels of Thymoglobulin as Part of a Myeloablative-Conditioning for a Human Leukocyte Antigen (HLA) Identical Matched Related Donor (MRD) Stem Cell Transplant (SCT) With Cyclosporine (CSa) as Post-transplant Graft vs. Host Disease (GvHD) Prophylaxis

This study involves the use of a drug called Thymoglobulin, which is approved in the USA to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection. Thymoglobulin is not approved for the treatment or prophylaxis of graft versus host disease in bone marrow transplantation. This study is to evaluate two (2) doses of Thymoglobulin and its safety and effectiveness when used with a "myeloablative" conditioning regimen prior to receiving a stem cell transplant (also called bone marrow transplantation) from a matched, related donor.

A myeloablative regimen is typically composed of chemotherapy and radiation and destroys the subject's existing bone marrow.

Read more

Subjects meeting all inclusion and exclusion criteria and who have a relative with matching (genetically similar) stem cells who are also willing to donate them (i.e. matched-related-donor) are eligible to participate in this study. Following myeloablative therapy, the donor's cells are then transplanted (i.e. infused) into the subject's blood stream.

One of the most common complications of this type of transplant is graft-versus-host disease (GvHD). This is a condition where the transplanted donor cells attack the transplant recipient's body. Treatments, such as cyclosporine, are used to minimize the risk of GvHD following stem cell transplantation.

To enter this study, subjects must be having a matched-related donor stem cell transplant. If a subject qualifies for entry into this study, he/she will be assigned to receive Thymoglobulin at a dose of 4.5 mg/kg or 8.5 mg/kg. The treatment assignment is random and is not chosen by the subject or their physician.

Subjects are admitted to the hospital for the transplant procedure and are treated with Thymoglobulin over 3-5 days just prior to receiving the donor stem cells. The subject will also receive standard GvHD prophylaxis with cyclosporine. Methotrexate, which is commonly used by transplant centers to minimize the risk of GvHD, will not be used in this study.

Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurs at month 1, 100 days and 6 months following the transplant.

Approximately 60 study subjects from approximately 14 transplant centers in the United States and Canada will be enrolled.

Being tested
Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]
Keywords
Acute myelogenous leukemia (AML), Acute lymphocytic leukemia (ALL), Anti-T cell antibodies, Allogenic stem cell transplant, Graft vs. Host Disease (GvHD)
Medical subject headings
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]Biological

    total dose 4.5 mg/kg

  • Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]Biological

    total dose 8.5 mg/kg

Study groups in NCT00088543
Study groupRoleWhat they receive
1 Low doseExperimentaltotal dose 4.5 mg/kg Thymoglobulin
Receives: Biological: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]
2 High doseExperimentaltotal dose 8.5 mg/kg Thymoglobulin
Receives: Biological: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Grade II to IV acute GvHD in the first 100 days after transplant.

    Measured: 100 days

Secondary outcomes (12)

  1. Incidence of treatment related adverse events and serious adverse events at 100 days and 6 months post transplant

    Measured: 100 days and 6 months

  2. Patient survival at 100 days and 6 months after transplant

    Measured: 100 days and 6 months

  3. transplant related mortality at 100 days or 6 months after transplant

    Measured: 100 days and 6 months

  4. severity and outcomes of acute GvHD

    Measured: 100 days & 6 mos

  5. any events of infection at 100 days and 6 months after transplant

    Measured: 100 days and 6 months

  6. incidence (or absence) of mucositis

    Measured: continuous

  7. how many days in the first month after transplant certain types of narcotics are used to reduce pain

    Measured: 30days

  8. whether the subject's blood counts after transplant reach a stable level and how quickly

    Measured: Continuous

  9. incidence of re-hospitalization in the first 6 months after transplant

    Measured: 6 months

  10. any recurrence of the subject's leukemic disease, and how long the subject was able to stay in remission

    Measured: Continuous

  11. incidence and severity of chronic GvHD, and the extent, after 100 days and 6 months after transplant

    Measured: 100 days and 6 months

  12. Disease free survival

    Measured: 100 days and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2004 (estimated)
  2. Study startMar 2004
  3. Primary completionApr 2006
  4. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00088543
Sponsor's protocol ID
SMC-101-1026
Status last verified
Mar 2015
First submitted
29 Jul 2004
Last updated
18 Mar 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] in people with Acute Myelogenous Leukemia (AML) and Acute Lymphocytic Leukemia (ALL), run by Genzyme, a Sanofi Company at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Grade II to IV acute GvHD in the first 100 days after transplant. (time frame: 100 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00088543.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.

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