Trial Outcomes & Findings for Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer (NCT NCT00074269)

NCT ID: NCT00074269

Last Updated: 2023-06-05

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 5 years post transplant
• Results posted on: 2023-06-05

Participant Flow

The protocol recruited patients with Metastatic breast cancer for transplant after ATG, high-dose Melphalan and Fludarabine.This was a non-randomized, single arm pilot study. Patients received fludarabine IV days -8 to -4, ATG IV on days -7 to -4 and High dose Melphalan days -3 to -2. This protocol is closed to accrual as of March 2008

Participant milestones

Measure	Treatment anti-thymocyte globulin filgrastim graft-versus-tumor induction therapy therapeutic allogeneic lymphocytes cyclosporine fludarabine phosphate melphalan methotrexate peripheral blood stem cell transplantation
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer

Baseline characteristics by cohort

Measure	Pilot Study of Allogeneic Transplant for Metastatic Breast Can n=5 Participants anti-thymocyte globulin filgrastim graft-versus-tumor induction therapy therapeutic allogeneic lymphocytes cyclosporine fludarabine phosphate melphalan methotrexate peripheral blood stem cell transplantation
Age, Continuous	45 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years post transplant

Population: study was closed early due to lack of accrual.

Outcome measures

Measure	Treatment n=5 Participants Toxicity anti-thymocyte globulin filgrastim graft-versus-tumor induction therapy therapeutic allogeneic lymphocytes cyclosporine fludarabine phosphate melphalan methotrexate peripheral blood stem cell transplantation
Number of Participants With Adverse Events	5 Participants

PRIMARY outcome

Timeframe: 30 days post transplant

Population: study was closed early due to lack of accrual.

Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes based on cell counts of ANC >1000 for 3 consecutive days and platelet count of >50,000

Outcome measures

Measure	Treatment n=5 Participants Toxicity anti-thymocyte globulin filgrastim graft-versus-tumor induction therapy therapeutic allogeneic lymphocytes cyclosporine fludarabine phosphate melphalan methotrexate peripheral blood stem cell transplantation
Number of Participants With Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes	5 Participants

PRIMARY outcome

Timeframe: 100 days post transplant

Population: study was closed early due to lack of accrual.

Outcome measures

Measure	Treatment n=5 Participants Toxicity anti-thymocyte globulin filgrastim graft-versus-tumor induction therapy therapeutic allogeneic lymphocytes cyclosporine fludarabine phosphate melphalan methotrexate peripheral blood stem cell transplantation
Number of Participants With Acute and Chronic Graft-versus-host Disease (GVHD)	3 Participants

SECONDARY outcome

Timeframe: From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Population: study was closed early due to lack of accrual.

Progression assessed by CT scan

Outcome measures

Measure	Treatment n=5 Participants Toxicity anti-thymocyte globulin filgrastim graft-versus-tumor induction therapy therapeutic allogeneic lymphocytes cyclosporine fludarabine phosphate melphalan methotrexate peripheral blood stem cell transplantation
Progression-free Survival	110 days Interval 8.0 to 180.0

SECONDARY outcome

Timeframe: 1 year from the time of transplant

Population: study was closed early due to lack of accrual.

Outcome measures

Measure	Treatment n=5 Participants Toxicity anti-thymocyte globulin filgrastim graft-versus-tumor induction therapy therapeutic allogeneic lymphocytes cyclosporine fludarabine phosphate melphalan methotrexate peripheral blood stem cell transplantation
Overall Survival	279.4 days Interval 98.0 to 373.0

SECONDARY outcome

Timeframe: From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Population: study was closed early due to lack of accrual.

response (partial and complete) assessed by CT scan at 12 months post allografting

Outcome measures

Measure	Treatment n=5 Participants Toxicity anti-thymocyte globulin filgrastim graft-versus-tumor induction therapy therapeutic allogeneic lymphocytes cyclosporine fludarabine phosphate melphalan methotrexate peripheral blood stem cell transplantation
Response as Measured at 12 Months Post Allografting	3 Participants

SECONDARY outcome

Timeframe: 1 month post allografting

Population: study was closed early due to lack of accrual.

Outcome measures

Measure	Treatment n=5 Participants Toxicity anti-thymocyte globulin filgrastim graft-versus-tumor induction therapy therapeutic allogeneic lymphocytes cyclosporine fludarabine phosphate melphalan methotrexate peripheral blood stem cell transplantation
Frequency of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1 Month Post Allografting	5 Participants

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 5 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=5 participants at risk The events monitored in the treatment arm of the protocol are listed below: incidence of Toxicity administration of filgrastim Grade of GVHD Initiation of graft-versus-tumor induction therapy Disease Status
Infections and infestations Infection	100.0% 5/5 • Number of events 5 • 5 years AEs and SAEs collected on all Patients
Blood and lymphatic system disorders Hematuria	20.0% 1/5 • Number of events 1 • 5 years AEs and SAEs collected on all Patients
Infections and infestations Fever	40.0% 2/5 • Number of events 2 • 5 years AEs and SAEs collected on all Patients
Skin and subcutaneous tissue disorders aGVHD Skin	40.0% 2/5 • Number of events 2 • 5 years AEs and SAEs collected on all Patients
Gastrointestinal disorders aGVHD Gut	20.0% 1/5 • Number of events 1 • 5 years AEs and SAEs collected on all Patients
Hepatobiliary disorders aGVHD Liver	40.0% 2/5 • Number of events 2 • 5 years AEs and SAEs collected on all Patients
Immune system disorders Overall GVHD	60.0% 3/5 • Number of events 3 • 5 years AEs and SAEs collected on all Patients
Eye disorders Bilteral Conjunctivitis	20.0% 1/5 • Number of events 1 • 5 years AEs and SAEs collected on all Patients
Hepatobiliary disorders ALT Elevation	40.0% 2/5 • Number of events 3 • 5 years AEs and SAEs collected on all Patients
Blood and lymphatic system disorders Hypokalemia	20.0% 1/5 • Number of events 1 • 5 years AEs and SAEs collected on all Patients
Blood and lymphatic system disorders Febrile Neutropenia	20.0% 1/5 • Number of events 1 • 5 years AEs and SAEs collected on all Patients
Hepatobiliary disorders AST Elevation	20.0% 1/5 • Number of events 1 • 5 years AEs and SAEs collected on all Patients
General disorders Pain	20.0% 1/5 • Number of events 1 • 5 years AEs and SAEs collected on all Patients
Respiratory, thoracic and mediastinal disorders Pleural Effusion	20.0% 1/5 • Number of events 1 • 5 years AEs and SAEs collected on all Patients
Cardiac disorders Bradycardia	20.0% 1/5 • Number of events 1 • 5 years AEs and SAEs collected on all Patients
Cardiac disorders Pericardial Effusion	20.0% 1/5 • Number of events 1 • 5 years AEs and SAEs collected on all Patients
Vascular disorders Capillary Leak Syndrome	20.0% 1/5 • Number of events 1 • 5 years AEs and SAEs collected on all Patients

Additional Information

Dr. Edward Ball, Director BMT Program

UCSD

Phone: 858-822-6600

Email: tball@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place