Trial Outcomes & Findings for Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma (NCT NCT00057954)

NCT ID: NCT00057954

Last Updated: 2023-06-28

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Assessed daily during inpatient stay
• Results posted on: 2023-06-28

Participant Flow

Participants were recruited from ECOG member institutions between June 1, 2005 and October 10, 2007 with the first patient accrued on November 9, 2005.

Participant milestones

Measure	Transplant Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Transplant Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
Overall Study Death	1
Overall Study Disease progression	1

Baseline Characteristics

Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma

Baseline characteristics by cohort

Measure	Transplant n=6 Participants Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
Age, Continuous	47 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed daily during inpatient stay

Population: all enrolled 6 patients

Outcome measures

Measure	Transplant n=6 Participants Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
Proportion of Participants With Successful Engraftment	1 Proportion of participants Interval 0.5 to 1.0

SECONDARY outcome

Timeframe: Assessed at least twice a week for the first 60 days and weekly until day 100.

Population: all 6 enrolled patients

Proportion of patients who survived 100 days or more after enrolled on the study

Outcome measures

Measure	Transplant n=6 Participants Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
100-day Overall Survival	0.83 Proportion of participants Interval 0.54 to 1.0

SECONDARY outcome

Timeframe: Assessed day 100 post transplant and every 3 months during year 1, every 6 months during years 2-3, then every 12 months during years 4-5 or through diagnosis of disease progression

Population: all 6 enrolled patients

Progression-free survival was defined as time from enrollment to disease progression or death from any cause, whichever occurred first. Patients who did not have progression-free survival events were censored at last date of disease assessment.

Outcome measures

Measure	Transplant n=6 Participants Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
Progression-free Survival	104 days Interval 66.0 to upper limit of confidence interval (CI) has not been reached

Adverse Events

Transplant

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Transplant n=6 participants at risk Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
Blood and lymphatic system disorders Anemia	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Leukopenia (Leukocytes, decreased)	100.0% 6/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Lymphopenia	100.0% 6/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Neutropenia (Neutrophils, decreased)	100.0% 6/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Thrombocytopenia (Platelets, decreased)	66.7% 4/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
General disorders Fatigue	33.3% 2/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Anorexia	33.3% 2/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Diarrhea w/o prior colostomy	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Nausea	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	66.7% 4/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Blood bilirubin increased	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyponatremia	33.3% 2/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Nervous system disorders Neuropathy-sensory	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Abdomen, pain	33.3% 2/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Nervous system disorders Head/headache	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Muscle, pain	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 2/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-other	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.

Other adverse events

Measure	Transplant n=6 participants at risk Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
Blood and lymphatic system disorders Anemia	100.0% 6/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Leukopenia (Leukocytes, decreased)	100.0% 6/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Lymphopenia	83.3% 5/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Neutropenia (Neutrophils, decreased)	83.3% 5/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Thrombocytopenia (Platelets, decreased)	100.0% 6/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
General disorders Fatigue	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
General disorders Fever w/o neutropenia	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Alopecia	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	33.3% 2/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Diarrhea w/o prior colostomy	33.3% 2/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Nausea	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders GI-other	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 6/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Alanine aminotransferase increased	50.0% 3/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Aspartate aminotransferase increased	66.7% 4/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Blood bilirubin increased	100.0% 6/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Investigations Creatinine, increased	83.3% 5/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Extremity-limb, pain	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Joint, pain	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Assessed every 30 days while on treatment and for 30 days after the end of treatment.

Additional Information

Study Statistician

ECOG Statistical Office

Phone: 617-632-3012

Results disclosure agreements

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