Trial Outcomes & Findings for Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NCT NCT00429026)

Results Overview

Number of participants surviving at 4 years compared to total participants, to compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen. Evaulation after 1, 2, 3, 6, 9, \& 12 months, then every 4 months for 4 years.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Up to 4 years

Results posted on

2013-03-04

Participant Flow

Enrollment Period: January 16, 2004 through March 29, 2006. All participants recruited at U.T. M.D. Anderson Cancer Center.

Only 5 patients received allogeneic stem cell transplantation while 35 received standard chemotherapy. Study terminated due to low patient accrual. This population was not analyzed by treatment arm on this study.

Participant milestones

Participant milestones
Measure	Conditioning Regimen Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
Overall Study STARTED	40
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Conditioning Regimen Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
Overall Study Inevaluable for response.	40

Baseline Characteristics

Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conditioning Regimen n=40 Participants Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
Age Continuous	48 years FULL_RANGE 0 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: Primary outcome measure was not assessed due to early study termination, e.g. patients did not receive assigned treatment.

Number of participants surviving at 4 years compared to total participants, to compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen. Evaulation after 1, 2, 3, 6, 9, \& 12 months, then every 4 months for 4 years.

Outcome measures

Outcome data not reported

Adverse Events

Conditioning Regimen

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Conditioning Regimen n=40 participants at risk Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
Gastrointestinal disorders Nausea	12.5% 5/40 • 2 years and 7 months
Gastrointestinal disorders Vomiting	12.5% 5/40 • 2 years and 7 months
Gastrointestinal disorders Diarrhea	12.5% 5/40 • 2 years and 7 months
General disorders Fatigue	12.5% 5/40 • 2 years and 7 months

Additional Information

Naoto Ueno, MD, PhD / Associate Professor

U.T. M.D. Anderson Cancer Center

Phone: 713-792-8754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place