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

• ClinicalTrials.gov Identifier: NCT00057954
• Recruitment Status: Terminated
• First Posted: April 9, 2003
• Results First Posted: February 8, 2013
• Last Update Posted: February 13, 2013
• Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Eastern Cooperative Oncology Group

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lymphoma
• Interventions: Procedure: Extracorporeal Photopheresis; Drug: Pentostatin; Radiation: Total body irradiation (TBI); Procedure: Allogeneic bone marrow transplantation; Drug: Cyclosporin (CSA); Drug: Mycophenolate mofetil (MMF); Drug: Methotrexate (MTX)
• Enrollment: 6

Participant Flow

Recruitment Details	Participants were recruited from ECOG member institutions between June 1, 2005 and October 10, 2007.
Pre-assignment Details

Arm/Group Title	Transplant
Arm/Group Description	Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
Period Title: Overall Study
Started	6
Completed	4
Not Completed	2
Reason Not Completed
Death	1
Disease progression	1

Baseline Characteristics

Arm/Group Title		Transplant
Arm/Group Description		Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
Overall Number of Baseline Participants		6
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	6 participants
		47; (21 to 60)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants
	Female	2 33.3%
	Male	4 66.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	6 participants
		6

Outcome Measures

1. Primary Outcome

Title	Proportion of Participants With Successful Engraftment
Description	[Not Specified]
Time Frame	Assessed daily during inpatient stay

Outcome Measure Data

Analysis Population Description

all enrolled 6 patients

Arm/Group Title	Transplant
Arm/Group Description:	Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
Overall Number of Participants Analyzed	6
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Proportion of participants
	1; (0.5 to 1.0)

2. Secondary Outcome

Title	100-day Overall Survival
Description	Proportion of patients who survived 100 days or more after enrolled on the study
Time Frame	Assessed at least twice a week for the first 60 days and weekly until day 100.

Outcome Measure Data

Analysis Population Description

all 6 enrolled patients

Arm/Group Title	Transplant
Arm/Group Description:	Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
Overall Number of Participants Analyzed	6
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Proportion of participants
	0.83; (0.54 to 1.0)

3. Secondary Outcome

Title	Progression-free Survival
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

all 6 enrolled patients

Arm/Group Title	Transplant
Arm/Group Description:	Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
Overall Number of Participants Analyzed	6
Median (95% Confidence Interval); Unit of Measure: days
	104 [1]; (66 to NA)

[1]

upper limit of confidence interval (CI) has not been reached

Adverse Events

Time Frame	Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Transplant
Arm/Group Description	Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
All-Cause Mortality
	Transplant
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Transplant
	Affected / at Risk (%)
Total	6/6 (100.00%)
Blood and lymphatic system disorders
Anemia † 1	1/6 (16.67%)
Gastrointestinal disorders
Diarrhea w/o prior colostomy † 1	1/6 (16.67%)
Nausea † 1	1/6 (16.67%)
Vomiting † 1	1/6 (16.67%)
Abdomen, pain † 1	2/6 (33.33%)
General disorders
Fatigue † 1	2/6 (33.33%)
Investigations
Leukopenia (Leukocytes, decreased) † 1	6/6 (100.00%)
Lymphopenia † 1	6/6 (100.00%)
Neutropenia (Neutrophils, decreased) † 1	6/6 (100.00%)
Thrombocytopenia (Platelets, decreased) † 1	4/6 (66.67%)
Aspartate aminotransferase increased † 1	1/6 (16.67%)
Blood bilirubin increased † 1	1/6 (16.67%)
Metabolism and nutrition disorders
Anorexia † 1	2/6 (33.33%)
Hypoalbuminemia † 1	4/6 (66.67%)
Hyponatremia † 1	2/6 (33.33%)
Musculoskeletal and connective tissue disorders
Muscle, pain † 1	1/6 (16.67%)
Nervous system disorders
Neuropathy-sensory † 1	1/6 (16.67%)
Head/headache † 1	1/6 (16.67%)
Respiratory, thoracic and mediastinal disorders
Dyspnea † 1	2/6 (33.33%)
Pulmonary/Upper Respiratory-other † 1	1/6 (16.67%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, CTCAE (3.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Transplant
	Affected / at Risk (%)
Total	6/6 (100.00%)
Blood and lymphatic system disorders
Anemia † 1	6/6 (100.00%)
Gastrointestinal disorders
Diarrhea w/o prior colostomy † 1	2/6 (33.33%)
Nausea † 1	1/6 (16.67%)
Vomiting † 1	1/6 (16.67%)
GI-other † 1	1/6 (16.67%)
General disorders
Fatigue † 1	1/6 (16.67%)
Fever w/o neutropenia † 1	1/6 (16.67%)
Investigations
Leukopenia (Leukocytes, decreased) † 1	6/6 (100.00%)
Lymphopenia † 1	5/6 (83.33%)
Neutropenia (Neutrophils, decreased) † 1	5/6 (83.33%)
Thrombocytopenia (Platelets, decreased) † 1	6/6 (100.00%)
Alanine aminotransferase increased † 1	3/6 (50.00%)
Aspartate aminotransferase increased † 1	4/6 (66.67%)
Blood bilirubin increased † 1	6/6 (100.00%)
Creatinine, increased † 1	5/6 (83.33%)
Metabolism and nutrition disorders
Hypoalbuminemia † 1	6/6 (100.00%)
Musculoskeletal and connective tissue disorders
Extremity-limb, pain † 1	1/6 (16.67%)
Joint, pain † 1	1/6 (16.67%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	1/6 (16.67%)
Skin and subcutaneous tissue disorders
Alopecia † 1	1/6 (16.67%)
Erythema multiforme † 1	2/6 (33.33%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, CTCAE (3.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Study Statistician
• Organization: ECOG Statistical Office
• Phone: 617-632-3012

• Responsible Party: Eastern Cooperative Oncology Group
• ClinicalTrials.gov Identifier: NCT00057954
• Other Study ID Numbers: CDR0000285659; U10CA021115 ( U.S. NIH Grant/Contract ); E1402 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Results First Submitted: January 7, 2013
• Results First Posted: February 8, 2013
• Last Update Posted: February 13, 2013