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Trial record 94 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT01499147
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : June 14, 2017
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Damiano Rondelli, MD, University of Illinois at Chicago

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia
Acute Leukemia
Chronic Myelogenous Leukemia
Malignant Lymphoma
Hodgkin's Disease
Multiple Myeloma
Lymphocytic Leukemia
Myeloproliferative Disorder
Polycythemia Vera
Myelofibrosis
Aplastic Anemia
Interventions Drug: fludarabine/busulfan
Drug: fludarabine/ melphalan
Drug: ATG
Enrollment 100
Recruitment Details We analyzed the clinical outcome of patients with hematological malignancies at standard or high-risk, who were transplanted (allogeneic peripheral blood or BMT HSCT) after receiving FluBU as a conditioning regimen. A total of 30 patients were recruited for this study which was conducted at the UIC Medical Center Inpatient BMT unit.
Pre-assignment Details Criteria for FluBu conditioning: <60 years old; no diagnosis of myeloma or myelofibrosis (MF) in chronic phase; and not having received an autologous stem cell transplant with the last 2 years. Patients not fulfilling these criteria but still eligible for allogeneic transplantation were prepared with FluMel.
Arm/Group Title Fludarabine/Busulfan + ATG Fludarabine/Melphalan + ATG
Hide Arm/Group Description

All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.

fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.

All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.

fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).

Period Title: Overall Study
Started 33 17
Completed 18 12
Not Completed 15 5
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.

fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.

All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.

fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).

Total of all reporting groups
Overall Number of Baseline Participants 18 12 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants 12 participants 30 participants
34
(19 to 61)
49
(22 to 61)
42.5
(19 to 61)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 12 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
12
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 12 participants 30 participants
Female
8
  44.4%
8
  66.7%
16
  53.3%
Male
10
  55.6%
4
  33.3%
14
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 12 participants 30 participants
18 12 30
1.Primary Outcome
Title Number of Participants With Engraftment.
Hide Description Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant.
Time Frame Up to 30 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fludarabine/Busulfan + ATG Fludarabine/Melphalan + ATG
Hide Arm/Group Description:

All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.

fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.

All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.

fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).

Overall Number of Participants Analyzed 18 12
Measure Type: Number
Unit of Measure: participants
18 12
2.Secondary Outcome
Title Participants With 100 Day Transplant-related Mortality.
Hide Description Day 100 transplant-related mortality was measured in both groups.
Time Frame Up to 100 days post-transplant.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fludarabine/Busulfan + ATG Fludarabine/Melphalan + ATG
Hide Arm/Group Description:

All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.

fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.

All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.

fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).

Overall Number of Participants Analyzed 18 12
Measure Type: Number
Unit of Measure: participants
1 1
3.Secondary Outcome
Title Time to ANC and Platelet Engraftment
Hide Description Days to ANC or platelet engraftment
Time Frame Up to 30 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fludarabine/Busulfan + ATG Fludarabine/Melphalan + ATG
Hide Arm/Group Description:

All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.

fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.

ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.

All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.

fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).

ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.

Overall Number of Participants Analyzed 18 12
Median (Full Range)
Unit of Measure: days to ANC and platelet engraftment
15
(0 to 24)
12
(10 to 22)
4.Secondary Outcome
Title Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).
Hide Description Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant.
Time Frame Up to 100 days post-transplant (acute GVHD).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fludarabine/Busulfan + ATG Fludarabine/Melphalan +ATG
Hide Arm/Group Description:

All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.

fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.

All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.

fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).

Overall Number of Participants Analyzed 18 12
Measure Type: Number
Unit of Measure: participants
2 1
Time Frame 365 days post-transplant
Adverse Event Reporting Description REGIMEN-RELATED TOXICITY ACCORDING TO ORGAN SYSTEM (ref: Bearman et al: J Clin Oncol vol 6, 1988, 1562-1568)
 
Arm/Group Title Participants With Extra-hematological Toxicities FluBu Participants With Extra-hematological Toxicities FluMel Participants With Extra-hematological Toxicities
Hide Arm/Group Description We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and FluMel and receiving PBSC. We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and receiving PBSC. We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluMel and receiving PBSC.
All-Cause Mortality
Participants With Extra-hematological Toxicities FluBu Participants With Extra-hematological Toxicities FluMel Participants With Extra-hematological Toxicities
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Participants With Extra-hematological Toxicities FluBu Participants With Extra-hematological Toxicities FluMel Participants With Extra-hematological Toxicities
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/30 (26.67%)      5/18 (27.78%)      3/12 (25.00%)    
Gastrointestinal disorders       
stomatitis  1  3/30 (10.00%)  3 2/18 (11.11%)  2 1/12 (8.33%)  1
Immune system disorders       
CMV reactivation  1  5/30 (16.67%)  5 3/18 (16.67%)  3 2/12 (16.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, Bearman criteria
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With Extra-hematological Toxicities FluBu Participants With Extra-hematological Toxicities FluMel Participants With Extra-hematological Toxicities
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/18 (0.00%)      0/12 (0.00%)    
Hepatobiliary disorders       
Veno-occlusive disease  1  0/30 (0.00%)  0 0/18 (0.00%)  0 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Bearman criteria
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: Damiano Rondelli, MD
Organization: University of Illinois Cancer Center
Phone: 312-996-6179
EMail: drond@uic.edu
Layout table for additonal information
Responsible Party: Damiano Rondelli, MD, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01499147     History of Changes
Other Study ID Numbers: 2000-0117
First Submitted: November 23, 2011
First Posted: December 26, 2011
Results First Submitted: June 19, 2015
Results First Posted: June 14, 2017
Last Update Posted: November 8, 2018