Trial Outcomes & Findings for Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib (NCT NCT00036738)

Results Overview

Number of patients with relapsed disease within 1 Year post-transplant. Relapse is defined as the detection of \> 5% blasts after a documented complete remission.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Assessed up to 1 year

Results posted on

2020-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Allogeneic Nonmyeloablative HSCT) See Detailed Description Cyclosporine: Given IV or PO Dasatinib: Given PO Fludarabine Phosphate: Given IV Imatinib Mesylate: Given PO Mycophenolate Mofetil: Given PO Nilotinib: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation Therapeutic Allogeneic Lymphocytes: Given IV Total-Body Irradiation: Undergo TBI
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Allogeneic Nonmyeloablative HSCT) n=28 Participants See Detailed Description Cyclosporine: Given IV or PO Dasatinib: Given PO Fludarabine Phosphate: Given IV Imatinib Mesylate: Given PO Mycophenolate Mofetil: Given PO Nilotinib: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation Therapeutic Allogeneic Lymphocytes: Given IV Total-Body Irradiation: Undergo TBI
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	57.6 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed up to 1 year

Number of patients with relapsed disease within 1 Year post-transplant. Relapse is defined as the detection of \> 5% blasts after a documented complete remission.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic Nonmyeloablative HSCT) n=28 Participants See Detailed Description Cyclosporine: Given IV or PO Dasatinib: Given PO Fludarabine Phosphate: Given IV Imatinib Mesylate: Given PO Mycophenolate Mofetil: Given PO Nilotinib: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation Therapeutic Allogeneic Lymphocytes: Given IV Total-Body Irradiation: Undergo TBI
Relapse Free Survival	3 Participants

SECONDARY outcome

Timeframe: Assessed up to 5 years

Number of patients surviving in CR up to five years post-transplant.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic Nonmyeloablative HSCT) n=28 Participants See Detailed Description Cyclosporine: Given IV or PO Dasatinib: Given PO Fludarabine Phosphate: Given IV Imatinib Mesylate: Given PO Mycophenolate Mofetil: Given PO Nilotinib: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation Therapeutic Allogeneic Lymphocytes: Given IV Total-Body Irradiation: Undergo TBI
Leukemia-free Survival 6 Months	19 Participants
Leukemia-free Survival 1 Year	17 Participants
Leukemia-free Survival 2 Years	13 Participants
Leukemia-free Survival 3 Years	11 Participants
Leukemia-free Survival 4 Years	11 Participants
Leukemia-free Survival 5 Years	10 Participants

SECONDARY outcome

Timeframe: Assessed up to 5 years

Number of patients surviving up to five years post-transplant.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic Nonmyeloablative HSCT) n=28 Participants See Detailed Description Cyclosporine: Given IV or PO Dasatinib: Given PO Fludarabine Phosphate: Given IV Imatinib Mesylate: Given PO Mycophenolate Mofetil: Given PO Nilotinib: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation Therapeutic Allogeneic Lymphocytes: Given IV Total-Body Irradiation: Undergo TBI
Overall Survival 5 Years	13 Participants
Overall Survival 6 Months	26 Participants
Overall Survival 1 Year	24 Participants
Overall Survival 2 Years	19 Participants
Overall Survival 3 Years	17 Participants
Overall Survival 4 Years	16 Participants

SECONDARY outcome

Timeframe: At day 100

Number of patients with TRM within 100 days post-transplant.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic Nonmyeloablative HSCT) n=28 Participants See Detailed Description Cyclosporine: Given IV or PO Dasatinib: Given PO Fludarabine Phosphate: Given IV Imatinib Mesylate: Given PO Mycophenolate Mofetil: Given PO Nilotinib: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation Therapeutic Allogeneic Lymphocytes: Given IV Total-Body Irradiation: Undergo TBI
Transplant-related Mortality	1 Participants

SECONDARY outcome

Timeframe: At 1 year

Number of patients with TRM within one year post-transplant.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic Nonmyeloablative HSCT) n=28 Participants See Detailed Description Cyclosporine: Given IV or PO Dasatinib: Given PO Fludarabine Phosphate: Given IV Imatinib Mesylate: Given PO Mycophenolate Mofetil: Given PO Nilotinib: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation Therapeutic Allogeneic Lymphocytes: Given IV Total-Body Irradiation: Undergo TBI
Transplant-related Mortality	3 Participants

Adverse Events

Treatment (Allogeneic Nonmyeloablative HSCT)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Allogeneic Nonmyeloablative HSCT) n=28 participants at risk See Detailed Description Cyclosporine: Given IV or PO Dasatinib: Given PO Fludarabine Phosphate: Given IV Imatinib Mesylate: Given PO Mycophenolate Mofetil: Given PO Nilotinib: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation Therapeutic Allogeneic Lymphocytes: Given IV Total-Body Irradiation: Undergo TBI
Investigations Blood bilirubin increased	3.6% 1/28 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Nervous system disorders Encephalopathy	3.6% 1/28 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Nervous system disorders Intracranial hemorrhage	3.6% 1/28 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200

Other adverse events

Other adverse events
Measure	Treatment (Allogeneic Nonmyeloablative HSCT) n=28 participants at risk See Detailed Description Cyclosporine: Given IV or PO Dasatinib: Given PO Fludarabine Phosphate: Given IV Imatinib Mesylate: Given PO Mycophenolate Mofetil: Given PO Nilotinib: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation Therapeutic Allogeneic Lymphocytes: Given IV Total-Body Irradiation: Undergo TBI
Immune system disorders Anaphylaxis	3.6% 1/28 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Cardiac disorders Atrial flutter	3.6% 1/28 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Investigations Blood bilirubin increased	10.7% 3/28 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	3.6% 1/28 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Gastrointestinal disorders Diarrhea	3.6% 1/28 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Blood and lymphatic system disorders Febrile neutropenia	3.6% 1/28 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.6% 1/28 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Nervous system disorders Transient ischemic attacks	3.6% 1/28 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200

Additional Information

Dr. George Georges

Fred Hutchinson Cancer Research Center

Phone: 206-667-6886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place