CClinicalTrials.gg
Sign In
Status unknownNCT00093587Updated Nov 6, 2013

Antithymocyte Globulin and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Chemotherapy With or Without Radiation Therapy Followed By Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

An interventional study of anti-thymocyte globulin and busulfan in Graft Versus Host Disease and Leukemia, sponsored by Jonsson Comprehensive Cancer Center. Status unknown at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-11-06.

Sponsored by Jonsson Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2006), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine after transplant may stop this from happening.

PURPOSE: This randomized clinical trial is studying how well giving antithymocyte globulin together with cyclosporine works in preventing graft-versus-host disease in patients who are undergoing chemotherapy with or without radiation therapy followed by donor stem cell transplant for acute lymphoblastic leukemia or acute myeloid leukemia.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the incidence of acute graft-vs-host disease (GVHD) within the first 100 days after transplantation in patients with acute lymphoblastic leukemia or acute myeloid leukemia treated with a myeloablative conditioning regimen comprising cyclophosphamide (with or without radiotherapy) and low- vs high-dose anti-thymocyte globulin followed by allogeneic HLA-matched related stem cell transplantation and cyclosporine.
  • Compare the incidence of serious adverse events within the first 100 days after transplantation in patients treated with these regimens.

Secondary

  • Compare 100-day and 6-month survival in patients treated with these regimens.
  • Compare the severity of acute GVHD in patients treated with these regimens.
  • Compare the incidence of culture-proven infections at 100 days and 6 months after transplantation in patients treated with these regimens.
  • Compare the incidence of mucositis, in terms of presence, severity, and duration, in patients treated with these regimens.
  • Compare the number of days on opiate drugs within the first 30 days after transplantation in patients treated with these regimens.
  • Compare the time to engraftment in patients treated with these regimens.
  • Compare the incidence of hospitalization within the first 6 months after transplantation, in terms of length of initial stay, cumulative total days, and number of hospitalizations, in patients treated with these regimens.
  • Compare the relapse rate and time to relapse in patients treated with these regimens.
  • Compare the incidence and severity of chronic GVHD between 100 days and 6 months after transplantation in patients treated with these regimens.

OUTLINE: This is a pilot, randomized, open-label, multicenter study.

  • Conditioning: All patients receive a standard myeloablative-conditioning regimen that contains cyclophosphamide IV over 2 hours per center regimen, typically on days -6 to -3. Patients also undergo total body irradiation OR receive busulfan.

  • Graft-versus-host disease (GVHD) prophylaxis (as part of conditioning): Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive low-dose anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.
    • Arm II: Patients receive high-dose anti-thymocyte globulin IV over 4-8 hours on days -5 to -1.
  • Allogeneic hematopoietic stem cell transplantation: Patients in both arms undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day 0.
  • Post-transplantation GVHD prophylaxis: Patients in both arms receive cyclosporine IV over 1-4 hours or orally twice daily beginning on day -1 and continuing until approximately day 60 followed by tapering doses until day 180 in the absence of GVHD.

Patients are followed at 7, 14, 21, 30, 100, and 180 days.

PROJECTED ACCRUAL: A total of 30-60 patients (15-30 per treatment arm) will be accrued for this study.

02

Conditions studied

  • Graft Versus Host Disease
  • Leukemia

Keywords

  • graft versus host disease
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • secondary acute myeloid leukemia
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

Browse Leukemia studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia

    • In first complete remission or second complete remission
  • Secondary AML allowed
  • HLA-A, -B, and -DRB1 identical related donor available AND must be fully matched at Class II by high-resolution molecular HLA typing (at least 4 digits)

  • Currently receiving a myeloablative conditioning regimen that includes cyclophosphamide

    • All patients from a center should receive the same conditioning regimen throughout the study
    • No fludarabine or other purine analogues (e.g. cladribine or pentostatin) as part of conditioning regimen
  • No uncontrolled CNS disease

PATIENT CHARACTERISTICS:

Age

  • 18 to 55

Performance status

  • ECOG 0-3

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin \< 2 mg/dL
  • ALT and/or AST ≤ 3 times normal

Renal

  • Creatinine \< 2.0 mg/dL OR
  • Creatinine clearance > 50 mL/min

Cardiovascular

  • Ejection fraction > 40%
  • No severe cardiac disease

Other

  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known contraindication to administration of rabbit anti-thymocyte globulin
  • No current drug or alcohol abuse
  • No significant medical or psychosocial problem or unstable disease state (including, but not limited to, morbid obesity) that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior or concurrent bone marrow transplantation from a donor who has positive serology for HIV, hepatitis B virus, hepatitis C virus, or syphilis
  • No IV immunoglobulin prior to engraftment
  • No concurrent ex vivo engineered or processed graft (CD34+ enrichment or T-cell depletion)

Chemotherapy

  • See Disease Characteristics
  • No prior or concurrent methotrexate for graft-vs-host disease prophylaxis

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 30 days since prior experimental agents

  • No other concurrent investigational agents

    • Enrollment in investigational studies (i.e., anti-microbial agents) allowed only for life threatening events or after exhausting other treatment modalities
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Masking
None (open label)

Interventions

  • Biologicalanti-thymocyte globulin
  • Drugbusulfan
  • Drugcyclophosphamide
  • Drugcyclosporine
  • Procedureallogeneic bone marrow transplantation
  • Procedureperipheral blood stem cell transplantation
  • Radiationradiation therapy
06

Study locations

1 site
  • Jonsson Comprehensive Cancer Center at UCLA
    Los Angeles, California 90095-1678, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00093587
Lead sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Oct 8, 2004
Start date
Aug 2004
Last update
Nov 6, 2013

Study contacts

Gary J. Schiller, MD
principal investigator · Jonsson Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia→

Other studies from this sponsor

Jonsson Comprehensive Cancer Center

Start the discussion