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Pilot Trial of Two Dose Levels of Thymoglobulin® as Part of a Myeloablative-Conditioning for a HLA Identical Matched Related Donor (MRD) Stem Cell Transplant With Cyclosporine (CsA) as Posttransplant Graft vs Host Disease (GvHD) Prophylaxis


N/A
18 Years
55 Years
Open (Enrolling)
Both
Graft Versus Host Disease, Leukemia

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Trial Information

Pilot Trial of Two Dose Levels of Thymoglobulin® as Part of a Myeloablative-Conditioning for a HLA Identical Matched Related Donor (MRD) Stem Cell Transplant With Cyclosporine (CsA) as Posttransplant Graft vs Host Disease (GvHD) Prophylaxis


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

Gary J. Schiller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000389241

NCT ID:

NCT00093587

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Graft Versus Host Disease
  • Leukemia
  • 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
  • Graft vs Host Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781