Probiotic Enteric Regimen For Easing Complications of Transplant : A Pilot Study (PERFECT Trial)
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Neuroblastoma, Ovarian Cancer, Testicular Germ Cell Tumor
Both
Breast Cancer, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Neuroblastoma, Ovarian Cancer, Testicular Germ Cell Tumor
Trial Information
Probiotic Enteric Regimen For Easing Complications of Transplant : A Pilot Study (PERFECT Trial)
OBJECTIVES:
- To determine if patients who are treated with a probiotic-containing diet develop
infection with one of the probiotic microorganisms while undergoing allogenic
hematopoietic stem cell transplantation for a hematologic malignancy or myelodysplastic
syndrome.
OUTLINE: Patients receive oral Lactobacillus rhamosus GG (Culturelle DS) once daily
beginning when blood counts have recovered without filgrastim (G-CSF) or sargramostim
(GM-CSF) support for 3 consecutive days and continuing for 1 year after transplantation.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Currently undergoing allogeneic stem cell transplantation from a related or unrelated
donor for a hematologic malignancy or myelodysplastic syndrome
- Hematopoietic engraftment as evidenced by recovery of the absolute neutrophil count >
1000/μL for > 3 days without filgrastim (G-CSF) support within 30 days of transplant
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Serum creatinine ≤ 2.0
- AST or ALT ≤ 3 times upper limit of normal (ULN)
- Total bilirubin ≤ 2.0 times ULN
- No clostridium difficile enterocolitis diagnosed during the transplant
hospitalization in the peri-transplant period
- Able to take medications by mouth
- No evidence of graft-vs-host disease
- No history of inflammatory bowel disease or other chronic diarrheal illness
- No history of hypersensitivity to milk proteins
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 months since prior use of probiotics supplements, excluding yogurt and
cheeses with live cultures
- No concurrent over-the-counter medications or herbal remedies
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Safety as indicated by the lack of infection attributable to probiotic organisms
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Roger Strair, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Institute of New Jersey
Authority:
United States: Institutional Review Board
Study ID:
060802
NCT ID:
NCT00946283
Start Date:
March 2010
Completion Date:
March 2013
Related Keywords:
- Breast Cancer
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
- Neuroblastoma
- Ovarian Cancer
- Testicular Germ Cell Tumor
- 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 Hodgkin lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic 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 Hodgkin lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic 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
- 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 large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent cutaneous T-cell non-Hodgkin 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 mycosis fungoides/Sezary syndrome
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- adult acute myeloid leukemia in remission
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- atypical chronic myeloid leukemia, BCR-ABL negative
- blastic phase chronic myelogenous leukemia
- chronic myelomonocytic leukemia
- chronic phase chronic myelogenous leukemia
- recurrent adult acute lymphoblastic leukemia
- recurrent adult acute myeloid leukemia
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- chronic eosinophilic leukemia
- primary myelofibrosis
- chronic neutrophilic leukemia
- de novo myelodysplastic syndromes
- disseminated neuroblastoma
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- previously treated myelodysplastic syndromes
- recurrent neuroblastoma
- recurrent ovarian epithelial cancer
- recurrent ovarian germ cell tumor
- recurrent malignant testicular germ cell tumor
- secondary myelodysplastic syndromes
- stage II multiple myeloma
- stage III multiple myeloma
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- stage III malignant testicular germ cell tumor
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- refractory multiple myeloma
- Breast Neoplasms
- Neoplasms
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Neuroblastoma
- Ovarian Neoplasms
- Lymphoma, Large-Cell, Immunoblastic
- Neoplasms, Germ Cell and Embryonal
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
