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Trial record 41 of 50 for:    "Essential Thrombocythemia" | "Anti-Infective Agents"

Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease

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ClinicalTrials.gov Identifier: NCT00719849
Recruitment Status : Terminated (A new protocol was developed to replace this protocol in 2008, with removal of ATG and extension of MMF duration.)
First Posted : July 22, 2008
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Colleen Delaney, 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 Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Interventions Biological: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: umbilical cord blood transplantation
Radiation: total body irradiation
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil

Period Title: Overall Study
Started 4 9
Completed 4 8
Not Completed 0 1
Reason Not Completed
Death             0             1
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG Total
Hide Arm/Group Description

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil

Total of all reporting groups
Overall Number of Baseline Participants 4 9 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 9 participants 13 participants
52.5
(24 to 67)
55.1
(37 to 68)
53.6
(24 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 9 participants 13 participants
Female
1
  25.0%
4
  44.4%
5
  38.5%
Male
3
  75.0%
5
  55.6%
8
  61.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 9 participants 13 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
  22.2%
2
  15.4%
White
4
 100.0%
7
  77.8%
11
  84.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 9 participants 13 participants
4
 100.0%
9
 100.0%
13
 100.0%
Disease Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 9 participants 13 participants
AML (Acute Myeloid Leukemia)
4
 100.0%
5
  55.6%
9
  69.2%
CML (Chronic Myeloid Leukemia)
0
   0.0%
1
  11.1%
1
   7.7%
NHL (Non-Hodgkin's Lymphoma)
0
   0.0%
1
  11.1%
1
   7.7%
MDS (Myelodysplastic Syndromes)
0
   0.0%
2
  22.2%
2
  15.4%
1.Primary Outcome
Title Probability of Survival at 1 Year
Hide Description Kaplan-Meier estimate of the probability of survival at 1 year
Time Frame 1 year post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: survival probability
0.25
(0.046 to 1.000)
0.50
(0.25 to 1.00)
2.Secondary Outcome
Title Probability of Survival at 2 Years
Hide Description Kaplan-Meier estimate of the probability of survival at 2 years
Time Frame 2 years post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: survival probability
0.25
(0.046 to 1.000)
0.38
(0.15 to 0.92)
3.Secondary Outcome
Title Incidence of Non-relapse Mortality at 6 Months
Hide Description Number of Participants with Non-relapse Mortality at 6 Months
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
2
  25.0%
4.Secondary Outcome
Title Chimerism
Hide Description Count of participants who experienced dominance of one cord blood unit (defined by >or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant.
Time Frame 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7
0
   0.0%
0
   0.0%
Day 14
0
   0.0%
0
   0.0%
Day 21
1
  25.0%
1
  12.5%
Day 28
1
  25.0%
5
  62.5%
Day 56
1
  25.0%
5
  62.5%
Day 80
1
  25.0%
6
  75.0%
6 months
2
  50.0%
7
  87.5%
1 year
2
  50.0%
7
  87.5%
2 years
2
  50.0%
7
  87.5%
5.Secondary Outcome
Title Incidence of Neutrophil Engraftment at Day 42
Hide Description Number of participants with neutrophil engraftment at day 42
Time Frame Day 42 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
7
  87.5%
6.Secondary Outcome
Title Incidence of Platelet Engraftment at 6 Months
Hide Description Number of participants with platelet engraftment at 6 months
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
2
  25.0%
7.Secondary Outcome
Title Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100
Hide Description

Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100.

Acute GVHD Staging and Grading:

Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)

Time Frame Day 100 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
6
  75.0%
8.Secondary Outcome
Title Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100
Hide Description

Number of participants with Grade III-IV acute graft-versus-host-disease (GVHD) at day 100.

Acute GVHD Staging and Grading:

Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)

Time Frame Day 100 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
1
  12.5%
9.Secondary Outcome
Title Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year
Hide Description

Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year.

Clinical Limited cGVHD

  1. Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD.
  2. Mild liver test abnormalities (alkaline phosphatase <2 x upper limit of normal, AST or ALT <3 x upper limit of normal and total bilirubin <1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD.
  3. Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving <20% of body surface area (BSA), dyspigmentation involving <20% BSA, or erythema involving <50% BSA, positive skin biopsy, and no other manifestations of cGVHD.
  4. Ocular sicca (Schirmer’s test <5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD.
  5. Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD.
Time Frame 1 year post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
  37.5%
10.Secondary Outcome
Title Incidence of Clinically Significant Infections at 6 Months
Hide Description Number of participants with clinically significant infections at 6 months
Time Frame 6 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
3
  37.5%
11.Secondary Outcome
Title Incidence of Clinically Significant Infections at 1 Year
Hide Description Number of participants with clinically significant infections at 1 year
Time Frame 1 year post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
3
  37.5%
12.Secondary Outcome
Title Incidence of Clinically Significant Infections at 2 Years
Hide Description Number of participants with clinically significant infections at 2 years
Time Frame 2 years post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
3
  37.5%
13.Secondary Outcome
Title Probability of Progression-free Survival at 1 Year
Hide Description Kaplan-Meier estimate of the probability of progression-free survival at 1 year
Time Frame 1 year post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: progression free survival probability
0.25
(0.046 to 1.000)
0.38
(0.15 to 0.92)
14.Secondary Outcome
Title Probability of Progression-free Survival at 2 Years
Hide Description Kaplan-Meier estimate of the probability of progression-free survival at 2 years
Time Frame 2 years post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: progression free survival probability
0.25
(0.046 to 1.000)
0.25
(0.075 to 0.83)
15.Secondary Outcome
Title Incidence of Relapse at 1 Year
Hide Description

Number of participants with relapse at 1 year.

Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

Time Frame 1 year post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
4
  50.0%
16.Secondary Outcome
Title Incidence of Relapse at 2 Years
Hide Description

Number of participants with relapse at 2 years.

Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

Time Frame 2 years post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description:

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
5
  62.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Hide Arm/Group Description

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil

All-Cause Mortality
Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      8/9 (88.89%)    
Blood and lymphatic system disorders     
Relapse of underlying disease  1/4 (25.00%)  1 5/9 (55.56%)  5
Failure to engraft by day 42  0/4 (0.00%)  0 1/9 (11.11%)  1
Secondary graft failure  0/4 (0.00%)  0 1/9 (11.11%)  1
Cardiac disorders     
Congestive heart failure  1/4 (25.00%)  1 0/9 (0.00%)  0
Hypertension  0/4 (0.00%)  0 1/9 (11.11%)  1
Supraventricular tachycardia  0/4 (0.00%)  0 1/9 (11.11%)  1
Gastrointestinal disorders     
Diarrhea  2/4 (50.00%)  2 0/9 (0.00%)  0
Obstruction, GI - biliary tree  0/4 (0.00%)  0 1/9 (11.11%)  1
General disorders     
MSOF leading to death  1/4 (25.00%)  1 0/9 (0.00%)  0
Fever of unknown etiology  1/4 (25.00%)  1 3/9 (33.33%)  3
Immune system disorders     
Allergic reaction  0/4 (0.00%)  0 1/9 (11.11%)  1
Infections and infestations     
Infection with grade 3 ANC - blood  1/4 (25.00%)  1 0/9 (0.00%)  0
Infection with grade 3 ANC - lungs  1/4 (25.00%)  1 0/9 (0.00%)  0
Infection with normal ANC - blood  0/4 (0.00%)  0 1/9 (11.11%)  1
Opportunistic infection associated with lymphopenia  0/4 (0.00%)  0 1/9 (11.11%)  1
Pneumonia  1/4 (25.00%)  1 2/9 (22.22%)  4
Encephalitis HHV6  0/4 (0.00%)  0 1/9 (11.11%)  1
Investigations     
Death  3/4 (75.00%)  3 8/9 (88.89%)  8
Metabolism and nutrition disorders     
Creatinine Phosphokinase  1/4 (25.00%)  1 0/9 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Myopathy  1/4 (25.00%)  1 0/9 (0.00%)  0
Renal and urinary disorders     
Acute renal failure  1/4 (25.00%)  1 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
ARDS  1/4 (25.00%)  1 0/9 (0.00%)  0
Hypoxia  0/4 (0.00%)  0 1/9 (11.11%)  1
Pulmonary VOD  0/4 (0.00%)  0 1/9 (11.11%)  1
Shortness of breath  0/4 (0.00%)  0 1/9 (11.11%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cyclophosphamide/Fludarabine/TBI Cyclophosphamide/Fludarabine/TBI/ATG
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      3/9 (33.33%)    
Blood and lymphatic system disorders     
Lymphopenia  1/4 (25.00%)  1 2/9 (22.22%)  2
Platelets  1/4 (25.00%)  1 2/9 (22.22%)  2
Hemoglobin  1/4 (25.00%)  1 0/9 (0.00%)  0
Neutrophils  1/4 (25.00%)  1 1/9 (11.11%)  1
Leukocytes  1/4 (25.00%)  1 1/9 (11.11%)  1
Infections and infestations     
Infection with grade 2 ANC - skin  1/4 (25.00%)  1 0/9 (0.00%)  0
Infection with normal ANC - blood  0/4 (0.00%)  0 1/9 (11.11%)  1
Infection with grade 4 ANC - blood  0/4 (0.00%)  0 1/9 (11.11%)  1
Infection with grade 4 ANC - oral  0/4 (0.00%)  0 1/9 (11.11%)  1
Metabolism and nutrition disorders     
Acidosis  1/4 (25.00%)  1 0/9 (0.00%)  0
Glucose, serum-high  1/4 (25.00%)  1 2/9 (22.22%)  2
Potassium, serum-high  1/4 (25.00%)  1 0/9 (0.00%)  0
Potassium, serum-low  1/4 (25.00%)  1 1/9 (11.11%)  1
Sodium, serum-low  2/4 (50.00%)  2 1/9 (11.11%)  1
Phosphate, serum-low  0/4 (0.00%)  0 1/9 (11.11%)  1
Magnesium, serum-high  0/4 (0.00%)  0 1/9 (11.11%)  1
AST  1/4 (25.00%)  1 0/9 (0.00%)  0
Vascular disorders     
Thrombus  0/4 (0.00%)  0 1/9 (11.11%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Colleen Delaney
Organization: Fred Hutchinson Cancer Research Center
Phone: 2066671385
EMail: cdelaney@fredhutch.org
Layout table for additonal information
Responsible Party: Colleen Delaney, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00719849     History of Changes
Other Study ID Numbers: 2012.00
FHCRC-2012.00 ( Other Identifier: FHCRC Protocol Number )
CDR0000597623 ( Registry Identifier: PDQ )
T32CA009515 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2008
First Posted: July 22, 2008
Results First Submitted: April 5, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017