Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT00691015
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    Given IV
  • busulfan — DRUG
    Given IV
  • carmustine — DRUG
    Given IV
  • cyclophosphamide — DRUG
    Given IV
  • cytarabine — DRUG
    Given IV
  • etoposide — DRUG
    Given IV
  • fludarabine phosphate — DRUG
    Given IV
  • melphalan — DRUG
    Given IV
  • total body irradiation (TBI) — RADIATION
    Given once or twice daily
  • anti-thymocyte globulin IV — DRUG
    Given IV

Study Details

RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and antithymocyte globulin before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with tacrolimus and antithymocyte globulin and to see how well it works in preventing graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem cell transplant.

Key Dates

Start date
May 31, 2008
Status verified
May 2017
Primary completion
Apr 30, 2014
Completion
Apr 30, 2014

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Chemotherapy or chemotherapy + total body irradiation
    Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens: Regimen I: Patients receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV. Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV;anti-thymocyte globulin IV. Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV; anti-thymocyte globulin IV. Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV. Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV; anti-thymocyte globulin IV. Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI; anti-thymocyte globulin IV.

Primary Outcome Measure

Incidence of Acute Graft-versus-host Disease (GVHD) [ Time Frame: Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria ]

Locations (1)

FacilityCityStateZIPSite coordinators
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-1379-

Find similar trials in Detroit, MI

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Barbara Ann Karmanos Cancer Institute· Detroit, MI

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