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Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Karen Ballen, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00133367
First received: August 19, 2005
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy followed by donor cord blood transplantation.


Condition Intervention Phase
Multiple Myeloma
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Myelogenous Leukemia
Lymphoblastic Leukemia
 Drug: Tacrolimus
Drug: Sirolimus
Drug: G-CSF
Drug: Antithymocyte globulin
Drug: Thymoglobulin
Drug: Fludarabine
Drug: Melphalan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Sequential Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the effectiveness of tacrolimus and sirolimus in preventing graft versus host disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the days to neutrophil engraftment and platelet engraftment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the relapse rate and overall disease free survival [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: August 2005
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tacrolimus
    Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.
    Drug: Sirolimus
    Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.
    Drug: G-CSF
    Given starting on day 5 after transplant until the subjects white blood cell count recovers.
    Drug: Antithymocyte globulin
    Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
    Drug: Thymoglobulin
    Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
    Drug: Fludarabine
    Given intravenously for six days prior to transplant (days 8,7,6,5,4,3).
    Drug: Melphalan
    Given intravenously on day 2 before transplant.
Detailed Description:
  • The chemotherapy portion of the study involves the intravenous administration of fludarabine, for six days (Days 8, 7, 6, 5,4, and 3) before transplant, melphalan, for one day (Day 2) before transplant. Antithymocyte globulin, or thymoglobulin, will be given IV daily for 4 days (days 7, 5, 3, and 1 before transplant). This drug also helps to suppress the immune system, allowing the cord blood cells to grow and reproduce.
  • Immunosuppression therapy consists of the drugs tacrolimus and sirolimus. The patient will receive these 3 days before the transplant and every day for 3-6 months after transplant. After the first 100 days post transplant, the doses of tacrolimus and sirolimus will begin to be reduced with the goal of having the patient off both drugs by 6-9 months after transplant.
  • After completion of conditioning therapy described above, the patient will receive 2 cord blood units 1-6 hours apart. To help with engraftment, the patient will also receive G-CSF starting on day five after transplant, until the patients white blood cells recover.
  • Follow-up visits will continue every 6 months after the last treatment dose and will last up to 2 years.
  • Blood tests will be drawn frequently to test whether the donor's immune cells have engrafted as well as to test the levels of Tacrolimus and Sirolimus.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate
  • Non-Hodgkin's lymphoma, or Hodgkin's lymphoma: in Complete Remission >2 (second complete remission, third complete remission, etc) or in partial remission
  • Multiple myeloma: relapsed
  • Chronic lymphocytic leukemia, Rai stage III or IV, or lymphocyte doubling time of 6 months, or stage I-II, having progressed after > 2 chemotherapy regimens, in partial remission.
  • Acute myelogenous or lymphoblastic leukemia in second or subsequent remission or in first remission with adverse cytogenetic or antecedent hematologic disorder
  • Chronic myelogenous leukemia in accelerated or second stable phase, or imatinib resistant and not eligible for an ablative transplant
  • Myelodysplasia, previously treated or not eligible for ablative transplant
  • Age 18-65 years.
  • ECOG performance status of 0, 1, or 2.
  • Lack of 6/6 or 5/6 HLA-matched related, 10/10 matched unrelated donor, or unrelated donor not available within the time frame necessary to perform a potentially curative stem cell transplant.

Exclusion Criteria:

  • Cardiac disease:

    • symptomatic congestive heart failure or
    • radionuclide ventriculogram (RVG) or echocardiogram determined left ventricular ejection fraction of < 40%,
    • active angina pectoris, or
    • uncontrolled hypertension.

  • Pulmonary disease:

    • severe chronic obstructive lung disease, or
    • symptomatic restrictive lung disease, or
    • corrected DLCO of < 50% of predicted.

  • Renal disease:

    • serum creatinine > 2.0 mg/dl.

  • Hepatic disease:

    • serum bilirubin > 2.0 mg/dl (except in the case of Gilbert's syndrome or hemolytic anemia in which the bilirubin can be elevated greater than 2.0mg/dl),
    • SGOT or SGPT > 3 x normal.

  • Neurologic disease:

    • symptomatic leukoencephalopathy,
    • active central nervous system (CNS) malignancy or other neuropsychiatric abnormalities believed to preclude transplantation (previous CNS malignancy, presently in complete remission [CR] is not exclusion).
  • HIV antibody.
  • Uncontrolled infection.
  • Pregnancy or breast feeding mother.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133367

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Karen K Ballen, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Karen Ballen, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00133367     History of Changes
Other Study ID Numbers: 05-154
Study First Received: August 19, 2005
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Hematologic malignancy
Cord blood transfusion
Graft versus host disease
tacrolimus
sirolimus

Additional relevant MeSH terms:
Graft vs Host Disease
Hodgkin Disease
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Antilymphocyte Serum
Melphalan
Fludarabine monophosphate
Sirolimus
Everolimus
Tacrolimus
Fludarabine

ClinicalTrials.gov processed this record on May 21, 2013