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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

Phase 2
50 Years
70 Years
Open (Enrolling)
Multiple Myeloma, Lymphoma, Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome

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Trial Information

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

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).

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

- 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

2. Patients with hematological malignancy relapsed after prior autologous

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The main endpoints are day 100 mortality and acute GVHD.

Principal Investigator

Peter A McSweeney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rocky Mountain Blood and Marrow Transplant Program


United States: Institutional Review Board

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Lymphoma
  • Acute Myelogenous Leukemia
  • Acute Lymphocytic Leukemia
  • Myelodysplastic Syndrome
  • Lymphoma
  • Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia



Rocky Mountain Blood and Marrow Transplant Program Denver, Colorado  80218