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Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00089011
Recruitment Status : Active, not recruiting
First Posted : August 5, 2004
Results First Posted : May 22, 2017
Last Update Posted : January 2, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Maloney, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions 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 Del(5q)
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)
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Blastic Phase Chronic Myelogenous Leukemia
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission
Childhood Burkitt Lymphoma
Childhood Chronic Myelogenous Leukemia
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Childhood Myelodysplastic Syndromes
Childhood Nasal Type Extranodal NK/T-cell Lymphoma
Chronic Phase Chronic Myelogenous Leukemia
Contiguous Stage II Adult Burkitt Lymphoma
Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Contiguous Stage II Adult Lymphoblastic Lymphoma
Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Contiguous Stage II Marginal Zone Lymphoma
Contiguous Stage II Small Lymphocytic Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
de Novo Myelodysplastic Syndromes
Essential Thrombocythemia
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Nodal Marginal Zone B-cell 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
Noncutaneous Extranodal Lymphoma
Peripheral T-cell Lymphoma
Polycythemia Vera
Post-transplant Lymphoproliferative Disorder
Previously Treated Myelodysplastic Syndromes
Primary Myelofibrosis
Prolymphocytic Leukemia
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 Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Anaplastic Large Cell Lymphoma
Recurrent Childhood Grade III Lymphomatoid Granulomatosis
Recurrent Childhood Large Cell Lymphoma
Recurrent Childhood Lymphoblastic Lymphoma
Recurrent Childhood Small Noncleaved Cell 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 Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Recurrent/Refractory Childhood Hodgkin Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Refractory Multiple Myeloma
Relapsing Chronic Myelogenous Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Stage I Adult Burkitt Lymphoma
Stage I Adult Diffuse Large Cell Lymphoma
Stage I Adult Diffuse Mixed Cell Lymphoma
Stage I Adult Diffuse Small Cleaved Cell Lymphoma
Stage I Adult Immunoblastic Large Cell Lymphoma
Stage I Adult Lymphoblastic Lymphoma
Stage I Adult T-cell Leukemia/Lymphoma
Stage I Childhood Anaplastic Large Cell Lymphoma
Stage I Childhood Large Cell Lymphoma
Stage I Childhood Lymphoblastic Lymphoma
Stage I Childhood Small Noncleaved Cell Lymphoma
Stage I Chronic Lymphocytic Leukemia
Stage I Cutaneous T-cell Non-Hodgkin 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 Multiple Myeloma
Stage I Small Lymphocytic Lymphoma
Stage IA Mycosis Fungoides/Sezary Syndrome
Stage IB Mycosis Fungoides/Sezary Syndrome
Stage II Adult T-cell Leukemia/Lymphoma
Stage II Childhood Anaplastic Large Cell Lymphoma
Stage II Childhood Large Cell Lymphoma
Stage II Childhood Lymphoblastic Lymphoma
Stage II Childhood Small Noncleaved Cell Lymphoma
Stage II Chronic Lymphocytic Leukemia
Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
Stage II Multiple Myeloma
Stage IIA Mycosis Fungoides/Sezary Syndrome
Stage IIB Mycosis Fungoides/Sezary Syndrome
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 Large Cell Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Stage III Adult T-cell Leukemia/Lymphoma
Stage III Childhood Anaplastic Large Cell Lymphoma
Stage III Childhood Large Cell Lymphoma
Stage III Childhood Lymphoblastic Lymphoma
Stage III Childhood Small Noncleaved Cell Lymphoma
Stage III Chronic Lymphocytic Leukemia
Stage III Cutaneous T-cell Non-Hodgkin 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 Multiple Myeloma
Stage III Small Lymphocytic Lymphoma
Stage IIIA Mycosis Fungoides/Sezary Syndrome
Stage IIIB Mycosis Fungoides/Sezary Syndrome
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 Large Cell Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage IV Adult T-cell Leukemia/Lymphoma
Stage IV Childhood Anaplastic Large Cell Lymphoma
Stage IV Childhood Large Cell Lymphoma
Stage IV Childhood Lymphoblastic Lymphoma
Stage IV Childhood Small Noncleaved Cell Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage IV Cutaneous T-cell Non-Hodgkin 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
Stage IVA Mycosis Fungoides/Sezary Syndrome
Stage IVB Mycosis Fungoides/Sezary Syndrome
Testicular Lymphoma
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Adult Acute Myeloid Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Waldenström Macroglobulinemia
Interventions Drug: fludarabine phosphate
Radiation: total-body irradiation
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: peripheral blood stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Hide Arm/Group Description

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

fludarabine phosphate: Given IV

total-body irradiation: Undergo radiotherapy

laboratory biomarker analysis: Correlative studies

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.

total-body irradiation: Undergo radiotherapy

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV or PO

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 100 50
Completed 100 50
Not Completed 0 0
Arm/Group Title Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI) Total
Hide Arm/Group Description

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

fludarabine phosphate: Given IV

total-body irradiation: Undergo radiotherapy

laboratory biomarker analysis: Correlative studies

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.

total-body irradiation: Undergo radiotherapy

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV or PO

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 100 50 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 50 participants 150 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
74
  74.0%
49
  98.0%
123
  82.0%
>=65 years
26
  26.0%
1
   2.0%
27
  18.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 50 participants 150 participants
Female
46
  46.0%
17
  34.0%
63
  42.0%
Male
54
  54.0%
33
  66.0%
87
  58.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 50 participants 150 participants
United States 98 46 144
Italy 2 4 6
1.Primary Outcome
Title Incidence of Grade III/IV GVHD
Hide Description

Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages

Skin:

a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation

Liver:

bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL

Gut:

Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.

aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Time Frame Day 180 post-transplantation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

fludarabine phosphate: Given IV

total-body irradiation: Undergo radiotherapy

laboratory biomarker analysis: Correlative studies

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.

total-body irradiation: Undergo radiotherapy

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV or PO

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 100 50
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.0%
4
   8.0%
2.Primary Outcome
Title Incidence of Chronic Extensive GVHD
Hide Description Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
Time Frame Day 180 post-transplantation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

fludarabine phosphate: Given IV

total-body irradiation: Undergo radiotherapy

laboratory biomarker analysis: Correlative studies

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.

total-body irradiation: Undergo radiotherapy

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV or PO

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 100 50
Measure Type: Count of Participants
Unit of Measure: Participants
15
  15.0%
6
  12.0%
3.Secondary Outcome
Title Incidences of Graft Rejection
Hide Description Number of patients who rejected their graft. Rejection is defined as the inability to detect or loss of detection of greater than 5% donor T cells (CD3+) as a proportion of the total T cell population, respectively, after nonmyeloablative HCT.
Time Frame Day 180 post-transplantation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

fludarabine phosphate: Given IV

total-body irradiation: Undergo radiotherapy

laboratory biomarker analysis: Correlative studies

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.

total-body irradiation: Undergo radiotherapy

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV or PO

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 100 50
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Overall Survival
Hide Description Number of patients surviving post-transplant.
Time Frame At 1 year after conditioning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

fludarabine phosphate: Given IV

total-body irradiation: Undergo radiotherapy

laboratory biomarker analysis: Correlative studies

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.

total-body irradiation: Undergo radiotherapy

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV or PO

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 100 50
Measure Type: Count of Participants
Unit of Measure: Participants
85
  85.0%
39
  78.0%
5.Secondary Outcome
Title Incidences of Grades II-IV Acute GVHD
Hide Description

Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages

Skin:

a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation

Liver:

bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL

Gut:

Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.

aGVHD Grades Grade II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Time Frame Day 180 post-transplantation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

fludarabine phosphate: Given IV

total-body irradiation: Undergo radiotherapy

laboratory biomarker analysis: Correlative studies

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.

total-body irradiation: Undergo radiotherapy

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV or PO

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 100 50
Measure Type: Count of Participants
Unit of Measure: Participants
26
  26.0%
14
  28.0%
6.Secondary Outcome
Title Rates of Disease Progression
Hide Description

Relapse/Progression criteria:

CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.

CMML, AML, ALL >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.

CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.

NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.

MM

≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.

Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

fludarabine phosphate: Given IV

total-body irradiation: Undergo radiotherapy

laboratory biomarker analysis: Correlative studies

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.

total-body irradiation: Undergo radiotherapy

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV or PO

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 100 50
Measure Type: Count of Participants
Unit of Measure: Participants
41
  41.0%
33
  66.0%
7.Secondary Outcome
Title Rates of Relapse-related Mortality
Hide Description Number of patients who expired with relapsed/progressive disease.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

fludarabine phosphate: Given IV

total-body irradiation: Undergo radiotherapy

laboratory biomarker analysis: Correlative studies

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.

total-body irradiation: Undergo radiotherapy

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV or PO

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 100 50
Measure Type: Count of Participants
Unit of Measure: Participants
28
  28.0%
23
  46.0%
8.Secondary Outcome
Title Rate and Duration of Steroid Use for the Treatment of Chronic GVHD
Hide Description Number of patients that received prednisone treatment of chronic GVHD, and number of days for which they received prednisone.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those patients who received steroids for treatment of chronic GVHD.
Arm/Group Title Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

fludarabine phosphate: Given IV

total-body irradiation: Undergo radiotherapy

laboratory biomarker analysis: Correlative studies

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.

total-body irradiation: Undergo radiotherapy

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV or PO

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 44 21
Median (Full Range)
Unit of Measure: days
78
(1 to 1156)
89
(1 to 420)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Hide Arm/Group Description

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

fludarabine phosphate: Given IV

total-body irradiation: Undergo radiotherapy

laboratory biomarker analysis: Correlative studies

Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.

total-body irradiation: Undergo radiotherapy

mycophenolate mofetil: Given IV or PO

tacrolimus: Given IV or PO

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/100 (8.00%)   5/50 (10.00%) 
Cardiac disorders     
Death, Renal Failure, Cardiac Failure *  1/100 (1.00%)  0/50 (0.00%) 
Eye disorders     
Right central artery occlusion with right eye blindness *  1/100 (1.00%)  0/50 (0.00%) 
Gastrointestinal disorders     
Perforated gastric ulcer *  0/100 (0.00%)  1/50 (2.00%) 
Hepatobiliary disorders     
Death, elevated bilirubin, fevers *  1/100 (1.00%)  0/50 (0.00%) 
Elevated LFT's with rising total bilirubin level   1/100 (1.00%)  0/50 (0.00%) 
Immune system disorders     
Death due to severe refractory autoimmune hemolytic anemia (present prior to transplant) *  1/100 (1.00%)  0/50 (0.00%) 
Severe abdominal pain due to gut GVHD and supravantricular arrhythmia/Atrial fibrillation *  1/100 (1.00%)  0/50 (0.00%) 
Infections and infestations     
Sepsis *  1/100 (1.00%)  0/50 (0.00%) 
Death, secondary to sepsis with multiorgan failure *  0/100 (0.00%)  1/50 (2.00%) 
Death due to adenovirus nephritis, sepsis, multifactorial renal failure *  0/100 (0.00%)  1/50 (2.00%) 
Psychiatric disorders     
Mental Status Change while on ativan, oxycodone, and flexeril *  1/100 (1.00%)  0/50 (0.00%) 
Renal and urinary disorders     
Elevated creatinine level  [1]  0/100 (0.00%)  1/50 (2.00%) 
Vascular disorders     
Hypoxia and Hypotension *  0/100 (0.00%)  1/50 (2.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Elevated creatinine level r/t acute renal failure in the setting of chronic kidney disease due to multiple myeloma
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Arm II (Nonmyeloablative Conditioning With TBI)
Affected / at Risk (%) Affected / at Risk (%)
Total   28/100 (28.00%)   17/50 (34.00%) 
Blood and lymphatic system disorders     
Hemolysis / Hemolytic Anemia   5/100 (5.00%)  1/50 (2.00%) 
Cardiac disorders     
Hypotension   1/100 (1.00%)  4/50 (8.00%) 
Hepatobiliary disorders     
Hyperbilirubinemia   8/100 (8.00%)  3/50 (6.00%) 
Renal and urinary disorders     
Increased Creatinine   20/100 (20.00%)  15/50 (30.00%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia / Hypoxemia   5/100 (5.00%)  2/50 (4.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: David G Maloney, MD PhD
Organization: Fred Hutch
Phone: (206) 667-5616
Responsible Party: David Maloney, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00089011     History of Changes
Other Study ID Numbers: 1898.00
NCI-2010-00267 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1898.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P01CA078902 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: August 4, 2004
First Posted: August 5, 2004
Results First Submitted: April 14, 2017
Results First Posted: May 22, 2017
Last Update Posted: January 2, 2018