Tacrolimus and MMF as Post Grafting Immunosuppression After Conditioning With Flu TBI for HLA Matched Family Donor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00304720
Recruitment Status : Unknown
Verified March 2004 by Colorado Blood Cancer Institute.
Recruitment status was:  Recruiting
First Posted : March 20, 2006
Last Update Posted : February 8, 2008
Information provided by:
Colorado Blood Cancer Institute

Brief Summary:

Primary Objective:

A. To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor, with fludarabine and low-dose TBI, with pre- and post-transplant immunosuppression with tacrolimus and MMF.

B. To evaluate the incidence of grade II-IV GVHD associated with this treatment.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Lymphoma Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome Drug: Tacrolimus and MMF Phase 2

Detailed Description:

Conditioning regimen:

  1. Days - 4 to -2: Fludarabine 30 mg/m2/day IV.
  2. Day 0: TBI 2.0 Gy at 6-7 cGy/min from a linear accelerator, followed by stem-cell infusion. TBI will preferably be administered between 7:00 a.m. and 1:00 p.m. to avoid proximity to tacrolimus/MMF administration.


Day -3: Start tacrolimus at 0.06 mg/kg PO BID. Day 0: Start MMF at 15 mg/kg PO b.i.d. from day 0 (PM dose only).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression After Conditioning With Fludarabine and Low-Dose Total Body Irradiation for Recipients of HLA-Matched Family Donor Hematopoietic Cell Transplants
Study Start Date : March 2004

Primary Outcome Measures :
  1. The main endpoints are day 100 mortality and acute GVHD.

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with AML, ALL, CML, CLL, myelodysplastic syndrome (MDS), NHL, Hodgkin's disease (HD), or myeloma, who are at significantly higher than usual risk for mortality from conventional myeloablative allogeneic SCT due to age or comorbidities:

  • Age ³ 50 years with AML or ALL in complete remission or with <10% blasts in bone marrow
  • Age ³ 50 years with MDS or CML.
  • Age > 50 years with lymphomas or myeloma, who have failed chemotherapy and are not candidates for an autologous transplant, or who have failed a prior autologous SCT.
  • Patients of any age with CLL or low-grade NHL. Patients with CLL and low-grade NHL need to have failed at least first-line treatment, with an alkylating agent, fludarabine or 2-chlorodeoxyadenosine (2-CDA), or anti-CD20 monoclonal antibody rituximab.

    2. Patients with hematological malignancy relapsed after prior autologous transplantation.

    3. Patients at high-risk (>60%) of relapsing after autologous transplantation for hematological malignancies may receive allogeneic transplant as "consolidative immunotherapy". Diagnoses include multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's lymphoma, AML, ALL and MDS. Minimal duration between autologous and allogeneic transplants is 4 weeks. 4. Patients of any age with hematologic malignancies treatable by allogeneic SCT, who, because of pre-existing medical conditions, are considered to be at significantly increased risk for transplant toxicity using high-dose transplant regimens. 5. Patients with metastatic renal cell carcinoma. Must have include good performance status (Karnofsky score > 60%), no active brain metastases, life expectancy > 6 months, absence of bulky liver metastases. Patients will be treated on other active disease-specific protocols when available. 6. Patients with other malignant diseases treatable with allogeneic SCT may be eligible for this protocol on a case by case basis, if approved by the principal investigator and the BMT attending physicians group. 7. Available HLA-identical sibling donor, or a phenotypically HLA-matched family member. 8. Age < 70 years.

Exclusion Criteria:

  1. Patients with hematological malignancies eligible for a curative autologous SCT: intermediate- or high-grade NHL with chemo-sensitive first relapse. HD with chemo-sensitive first relapse.
  2. Age <50 years and eligible for a conventional myeloablative allogeneic SCT.
  3. Patients with rapidly progressive intermediate or high- grade NHL, unless in minimal disease state.
  4. Patients with active uncontrolled CNS involvement with malignancy.
  5. Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment.
  6. Females who are pregnant.
  7. Patients who are HIV positive
  8. Organ dysfunction

    1. Left ventricle ejection fraction < 35%.
    2. DLCO <35% of predicted, or receiving continuous supplementary oxygen.
    3. Liver function tests: total bilirubin >2x the upper limit of normal, and/or transaminases >4x the upper limit of normal.
    4. Karnofsky score <50 for patients < 60 years, or <70 for patients aged 60 - 69 years (see appendix B).
    5. Creatinine clearance < 60 ml/min.
    6. Patients with hypertension that is poorly controlled on antihypertensive therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00304720

United States, Colorado
Rocky Mountain Blood and Marrow Transplant Program Recruiting
Denver, Colorado, United States, 80218
Contact: Peter A McSweeney, MD    303-336-2184   
Contact: Juli B Murphy    303-285-5087   
Sub-Investigator: Robert M Rifkin, MD         
Principal Investigator: Peter A McSweeney, MD         
Sub-Investigator: Jeffrey V Matous, MD         
Sub-Investigator: Scott I Bearman, MD         
Sub-Investigator: Mark W Brunvand, MD         
Sub-Investigator: Michael B Maris, MD         
Sponsors and Collaborators
Colorado Blood Cancer Institute
Principal Investigator: Peter A McSweeney, MD Colorado Blood Cancer Institute Identifier: NCT00304720     History of Changes
Other Study ID Numbers: RMBMT-124-A
First Posted: March 20, 2006    Key Record Dates
Last Update Posted: February 8, 2008
Last Verified: March 2004

Keywords provided by Colorado Blood Cancer Institute:

Additional relevant MeSH terms:
Multiple Myeloma
Myelodysplastic Syndromes
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Lymphatic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors