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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2004 by Colorado Blood Cancer Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Colorado Blood Cancer Institute
ClinicalTrials.gov Identifier:
NCT00304720
First received: March 17, 2006
Last updated: February 6, 2008
Last verified: March 2004
  Purpose

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 Intervention Phase
Multiple Myeloma
Lymphoma
Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Myelodysplastic Syndrome
Drug: Tacrolimus and MMF
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: 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

Resource links provided by NLM:


Further study details as provided by Colorado Blood Cancer Institute:

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

Estimated Enrollment: 40
Study Start Date: March 2004
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.

Immunosuppression:

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).

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304720

Locations
United States, Colorado
Rocky Mountain Blood and Marrow Transplant Program Recruiting
Denver, Colorado, United States, 80218
Contact: Peter A McSweeney, MD    303-336-2184    Peter.McSweeney@usoncology.com   
Contact: Juli B Murphy    303-285-5087    Juli.Murphy@usoncology.com   
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
Investigators
Principal Investigator: Peter A McSweeney, MD Colorado Blood Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00304720     History of Changes
Other Study ID Numbers: RMBMT-124-A
Study First Received: March 17, 2006
Last Updated: February 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Colorado Blood Cancer Institute:
Lymphoma
Leukemia

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

ClinicalTrials.gov processed this record on April 17, 2014