Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Completed
CT.gov ID
NCT00006350
Collaborator
(none)
1
22

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies such as daclizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation from a brother or sister may be effective treatment for hematologic cancer. Sometimes the transplanted cells can be rejected by the body's tissue. Mycophenolate mofetil, tacrolimus, and donor white blood cells may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of mycophenolate mofetil, tacrolimus, daclizumab, and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.

Condition or Disease Intervention/Treatment Phase
  • Biological: daclizumab
  • Biological: therapeutic allogeneic lymphocytes
  • Drug: mycophenolate mofetil
  • Drug: tacrolimus
  • Procedure: peripheral blood stem cell transplantation
Phase 2

Detailed Description

OBJECTIVES: I. Determine whether donor hematopoiesis can be safely established using a nonmyeloablative conditioning regimen followed by HLA matched sibling donor peripheral blood stem cell transplantation in patients with hematologic malignancies. II. Determine whether mixed chimerism can be safely converted to full donor hematopoiesis with this treatment regimen in these patients. III. Determine the toxicity and incidence of aplasia and graft versus host disease in these patients treated with this regimen. IV. Determine the antitumor potential of this treatment regimen in these patients. V. Determine the role of NFkB in the modulation of the cytokine secretion profile of T lymphocytes during an alloimmune response in these patients treated with this regimen.

OUTLINE: Patients receive immunosuppressive medications consisting of oral mycophenolate mofetil and tacrolimus twice a day beginning on day -8 and continuing through day 45 (in the absence of graft versus host disease). Patients also receive daclizumab IV over 30 minutes on days -1, 3, and 8. Patients undergo allogeneic peripheral blood stem cell (PBSC) transplantation with donor CD34+ cells IV on day 0. If there is 0-80% donor hematopoiesis, patients receive donor lymphocyte infusions with CD3+ cells IV on days 75, 165, and 270.

PROJECTED ACCRUAL: A total of 10-45 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies After a Non-Myeloablative Conditioning Regimen From HLA-Matched Sibling Donors
Actual Study Start Date :
Jan 1, 2000
Actual Primary Completion Date :
Nov 1, 2001
Actual Study Completion Date :
Nov 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS: Diagnosis of any of the following hematologic malignancies:

    Multiple myeloma Non-Hodgkin's lymphoma Indolent OR Relapsed or primary refractory high grade or intermediate grade in complete remission (CR) or partial remission (PR) after salvage chemotherapy or autologous bone marrow transplantation Hodgkin's disease Relapsed or primary refractory in CR or PR after salvage chemotherapy or autologous bone marrow transplantation Chronic lymphocytic leukemia Chronic myeloid leukemia Myelodysplastic syndrome Acute myeloid leukemia with high risk CR1 or second or greater CR Acute lymphocytic leukemia with high risk CR1 or second or greater CR Must have a 6 antigen HLA identical sibling donor Must have one of the following conditions that confer an increased risk for undergoing allogeneic bone marrow transplantation after myeloablative preparative regimen: Over 55 years of age AST or ALT greater than 2.5 times upper limit of normal (ULN) Bilirubin greater than 1.8 times ULN Renal dysfunction with creatinine greater than 1.5 mg/dL (after 12 courses of prior cytotoxic therapy) Undergone one or more prior autologous bone marrow transplantations Refuse to undergo allogeneic bone marrow transplantation using a myeloablative preparative regimen A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

    PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: See Disease Characteristics Other: Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201

    Sponsors and Collaborators

    • University of Maryland, Baltimore

    Investigators

    • Study Chair: Bijoyesh Mookerjee, MD, Jefferson Medical College of Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT00006350
    Other Study ID Numbers:
    • MSGCC-0012
    • CDR0000068212
    • NCI-V00-1624
    First Posted:
    Mar 8, 2004
    Last Update Posted:
    Nov 4, 2019
    Last Verified:
    Oct 1, 2019
    Keywords provided by University of Maryland, Baltimore
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 4, 2019