Trial Outcomes & Findings for Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma (NCT NCT00265889)

NCT ID: NCT00265889

Last Updated: 2013-11-20

Results Overview

Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: one year after second transplant
• Results posted on: 2013-11-20

Participant Flow

Patients recruited from medical clinic from August 2002 thru October 2010.

Only Poor Risk Patients were enrolled.

Participant milestones

Measure	Poor Risk Patients Poor Risk (primary progressive, recurrent, or resistant relapse)
Overall Study STARTED	42
Overall Study Cycle 1: 1st Regimen/Transplant	37
Overall Study Cycle 2: 2nd Regimen/Transplant	37
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Poor Risk Patients Poor Risk (primary progressive, recurrent, or resistant relapse)
Overall Study Physician Decision	1
Overall Study Protocol Violation	1
Overall Study Insurance denied the request	3

Baseline Characteristics

Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma

Baseline characteristics by cohort

Measure	Poor Risk Patients n=37 Participants Poor Risk (primary progressive, recurrent, or resistant relapse)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants

PRIMARY outcome

Timeframe: one year after second transplant

Population: Analysis is per protocol, so includes patients who received both transplants

Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions.

Outcome measures

Measure	Poor Risk Patients n=37 Participants Poor Risk (primary progressive, recurrent, or resistant relapse)
Progression-free Survival	18 participants

PRIMARY outcome

Timeframe: One year after second transplant

Population: Analysis is per protocol, so includes patients who received both transplants

Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as >/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions.

Outcome measures

Measure	Poor Risk Patients n=37 Participants Poor Risk (primary progressive, recurrent, or resistant relapse)
Response Rate Complete Response	18 participants
Response Rate Progression	14 participants
Response Rate Unknown	2 participants
Response Rate Expired	3 participants
Response Rate Partial Response	0 participants

PRIMARY outcome

Timeframe: One year after second transplant

Population: Analysis is per protocol, so includes patients who received treatment

Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.

Outcome measures

Measure	Poor Risk Patients n=37 Participants Poor Risk (primary progressive, recurrent, or resistant relapse)
Number of Patients That Experience Pulmonary Toxicity	9 participants

Adverse Events

Poor Risk Patients

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Poor Risk Patients n=37 participants at risk Poor Risk (primary progressive, recurrent, or resistant relapse)
Respiratory, thoracic and mediastinal disorders Pulmonary Toxicity	2.7% 1/37 • Adverse events were collected from the time the patient went on study to off study, approximately a 6 month time frame per patient.

Other adverse events

Measure	Poor Risk Patients n=37 participants at risk Poor Risk (primary progressive, recurrent, or resistant relapse)
Respiratory, thoracic and mediastinal disorders Pulmonary Toxicity	21.6% 8/37 • Adverse events were collected from the time the patient went on study to off study, approximately a 6 month time frame per patient.
Cardiac disorders Cardiac Dysfuntion	10.8% 4/37 • Adverse events were collected from the time the patient went on study to off study, approximately a 6 month time frame per patient.
General disorders Fever	13.5% 5/37 • Adverse events were collected from the time the patient went on study to off study, approximately a 6 month time frame per patient.
Infections and infestations Infections	29.7% 11/37 • Adverse events were collected from the time the patient went on study to off study, approximately a 6 month time frame per patient.
Respiratory, thoracic and mediastinal disorders Respiratory Dysfunction	8.1% 3/37 • Adverse events were collected from the time the patient went on study to off study, approximately a 6 month time frame per patient.
Renal and urinary disorders Acute Renal Failure	2.7% 1/37 • Adverse events were collected from the time the patient went on study to off study, approximately a 6 month time frame per patient.
Gastrointestinal disorders Gastrointestinal-other	2.7% 1/37 • Adverse events were collected from the time the patient went on study to off study, approximately a 6 month time frame per patient.

Additional Information

Brian Bowell, MD

Case Comprehensive Cancer Center

Phone: 216-444-6922

Email: bolwelb@ccf.org

Results disclosure agreements

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