# Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

> **NCT00105001** · PHASE2 · COMPLETED · sponsor: **Fred Hutchinson Cancer Center** · enrollment: 210 (actual)

## Conditions studied

- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Previously Treated Myelodysplastic Syndrome
- Refractory Chronic Lymphocytic Leukemia
- Refractory Plasma Cell Myeloma
- Waldenstrom Macroglobulinemia
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
- Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
- Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
- Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
- Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Childhood Acute Lymphoblastic Leukemia in Remission
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Burkitt Lymphoma
- Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Childhood Diffuse Large Cell Lymphoma
- Childhood Immunoblastic Lymphoma
- Childhood Myelodysplastic Syndrome
- Stage II Contiguous Adult Burkitt Lymphoma
- Stage II Contiguous Adult Diffuse Large Cell Lymphoma
- Stage II Contiguous Adult Diffuse Mixed Cell Lymphoma
- Stage II Contiguous Adult Diffuse Small Cleaved Cell Lymphoma
- Stage II Adult Contiguous Immunoblastic Lymphoma
- Stage II Contiguous Adult Lymphoblastic Lymphoma
- Stage II Grade 1 Contiguous Follicular Lymphoma
- Stage II Grade 2 Contiguous Follicular Lymphoma
- Stage II Grade 3 Contiguous Follicular Lymphoma
- Stage II Contiguous Mantle Cell Lymphoma
- Stage II Non-Contiguous Adult Burkitt Lymphoma
- Stage II Non-Contiguous Adult Diffuse Large Cell Lymphoma
- Stage II Non-Contiguous Adult Diffuse Mixed Cell Lymphoma
- Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma
- Stage II Adult Non-Contiguous Immunoblastic Lymphoma
- Stage II Non-Contiguous Adult Lymphoblastic Lymphoma
- Stage II Grade 1 Non-Contiguous Follicular Lymphoma
- Stage II Grade 2 Non-Contiguous Follicular Lymphoma
- Stage II Grade 3 Non-Contiguous Follicular Lymphoma
- Stage II Non-Contiguous Mantle Cell Lymphoma
- Stage II Small Lymphocytic Lymphoma
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult Immunoblastic Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Recurrent Childhood Anaplastic Large Cell Lymphoma
- Recurrent Childhood Large Cell Lymphoma
- Recurrent Childhood Lymphoblastic Lymphoma
- Recurrent Childhood Burkitt Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Small Lymphocytic Lymphoma
- Recurrent Childhood Hodgkin Lymphoma
- Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Secondary Myelodysplastic Syndrome
- Stage I Adult Burkitt Lymphoma
- Stage I Adult Diffuse Large Cell Lymphoma
- Stage I Adult Diffuse Mixed Cell Lymphoma
- Stage I Adult Immunoblastic Lymphoma
- Stage I Adult Lymphoblastic Lymphoma
- Stage I Childhood Anaplastic Large Cell Lymphoma
- Stage I Childhood Large Cell Lymphoma
- Stage I Childhood Lymphoblastic Lymphoma
- Stage I Childhood Burkitt Lymphoma
- Stage I Grade 1 Follicular Lymphoma
- Stage I Grade 2 Follicular Lymphoma
- Stage I Grade 3 Follicular Lymphoma
- Stage I Mantle Cell Lymphoma
- Stage I Marginal Zone Lymphoma
- Stage I Small Lymphocytic Lymphoma
- Stage II Childhood Anaplastic Large Cell Lymphoma
- Stage II Childhood Lymphoblastic Lymphoma
- Stage II Childhood Burkitt Lymphoma
- Stage III Adult Burkitt Lymphoma
- Stage III Adult Diffuse Large Cell Lymphoma
- Stage III Adult Diffuse Mixed Cell Lymphoma
- Stage III Adult Diffuse Small Cleaved Cell Lymphoma
- Stage III Adult Immunoblastic Lymphoma
- Stage III Adult Lymphoblastic Lymphoma
- Stage III Childhood Anaplastic Large Cell Lymphoma
- Stage III Childhood Large Cell Lymphoma
- Stage III Childhood Lymphoblastic Lymphoma
- Stage III Childhood Burkitt Lymphoma
- Stage III Grade 1 Follicular Lymphoma
- Stage III Grade 2 Follicular Lymphoma
- Stage III Grade 3 Follicular Lymphoma
- Stage III Mantle Cell Lymphoma
- Stage III Marginal Zone Lymphoma
- Stage III Small Lymphocytic Lymphoma
- Stage IV Adult Burkitt Lymphoma
- Stage IV Adult Diffuse Large Cell Lymphoma
- Stage IV Adult Diffuse Mixed Cell Lymphoma
- Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
- Stage IV Adult Immunoblastic Lymphoma
- Stage IV Adult Lymphoblastic Lymphoma
- Stage IV Childhood Anaplastic Large Cell Lymphoma
- Stage IV Childhood Large Cell Lymphoma
- Stage IV Childhood Lymphoblastic Lymphoma
- Stage IV Childhood Burkitt Lymphoma
- Stage IV Grade 1 Follicular Lymphoma
- Stage IV Grade 2 Follicular Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Stage IV Mantle Cell Lymphoma
- Stage IV Marginal Zone Lymphoma
- Stage IV Small Lymphocytic Lymphoma

## Interventions

- **DRUG:** Fludarabine Phosphate
- **RADIATION:** Total-Body Irradiation
- **PROCEDURE:** Peripheral Blood Stem Cell Transplantation
- **PROCEDURE:** Allogeneic Hematopoietic Stem Cell Transplantation
- **DRUG:** Tacrolimus
- **DRUG:** Mycophenolate Mofetil
- **DRUG:** Sirolimus

## Key facts

- **NCT ID:** NCT00105001
- **Lead sponsor:** Fred Hutchinson Cancer Center
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2004-11
- **Primary completion:** 2011-05
- **Final completion:** 2015-05-08
- **Target enrollment:** 210 (ACTUAL)
- **Last updated:** 2019-10-30

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00105001

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00105001, "Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT00105001. Licensed CC0.

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