Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant

• ClinicalTrials.gov Identifier: NCT00534118
• Recruitment Status: Completed
• First Posted: September 24, 2007
• Results First Posted: August 26, 2020
• Last Update Posted: August 26, 2020
• Sponsor: Roswell Park Cancer Institute
• Information provided by (Responsible Party): Roswell Park Cancer Institute

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes
• Intervention: Biological: donor lymphocytes
• Enrollment: 39

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Multiple DLI	Single DLI
Arm/Group Description	Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions	accruals where the patient received only one donor lymphocyte infusion
Period Title: Overall Study
Started	17	22
Completed	17	22
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Multiple DLI	Single DLI	Total
Arm/Group Description		Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions	Accruals where the patient received only one donor lymphocyte infusion	Total of all reporting groups
Overall Number of Baseline Participants		15	12	27
Baseline Analysis Population Description		Participants can be accrued more than once; Accruals are based on the number of times the participant had a treatment (DLI) cycle that was evaluable (ie. >8 weeks between infusions per the protocol). DLIs which were given <8 weeks apart counted as one accrual.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	12 participants	27 participants
	<=18 years	1 6.7%	1 8.3%	2 7.4%
	Between 18 and 65 years	12 80.0%	9 75.0%	21 77.8%
	>=65 years	2 13.3%	2 16.7%	4 14.8%
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	15 participants	12 participants	27 participants
		45; (16 to 66)	53.5; (9 to 68)	51; (9 to 68)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	12 participants	27 participants
	Female	5 33.3%	2 16.7%	7 25.9%
	Male	10 66.7%	10 83.3%	20 74.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	12 participants	27 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	15 100.0%	12 100.0%	27 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	12 participants	27 participants
	American Indian or Alaska Native	1 6.7%	0 0.0%	1 3.7%
	Asian	1 6.7%	0 0.0%	1 3.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	13 86.7%	12 100.0%	25 92.6%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	15 participants	12 participants	27 participants
		15	12	27
Disease; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	12 participants	27 participants
	Acute Myeloid Leukemia	8 53.3%	9 75.0%	17 63.0%
	Myelodysplastic Syndrome	2 13.3%	0 0.0%	2 7.4%
	Non Hodgkin Leukemia	2 13.3%	1 8.3%	3 11.1%
	Acute Lymphoblastic Leukemia	1 6.7%	0 0.0%	1 3.7%
	Chronic Myeloid Leukemia	1 6.7%	1 8.3%	2 7.4%
	Hodgkin Lymphoma	1 6.7%	0 0.0%	1 3.7%
	Prolymphocytic Leukemia	0 0.0%	1 8.3%	1 3.7%

Outcome Measures

1. Primary Outcome

Title	Complete Remission Rate
Description	continued or induced complete remission after DLI
Time Frame	100 days post DLI

Outcome Measure Data

Analysis Population Description

Each accrual is evaluable independently, some patients in both the Multiple and Single DLI are accrued more than once; total unique patients in multiple DLI is 15 and in single DLI is 12

Arm/Group Title	Multiple DLI	Single DLI
Arm/Group Description:	Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions	accruals where the patient received only one donor lymphocyte infusion
Overall Number of Participants Analyzed	17	22
Measure Type: Count of Participants; Unit of Measure: Participants
	8 47.1%	6 27.3%

2. Primary Outcome

Title	Duration of Complete Response in Months (Maximum 12)
Description	For participants who achieve a complete remission after DLI, the duration of time until 1) relapse or 2) death in remission or 3) subsequent DLI or 4) last followup (at 1 year after DLI)
Time Frame	1 year post DLI

Outcome Measure Data

Analysis Population Description

Accruals which achieved a continued or induced complete remission at Day +100 after DLI, patients are censored at death in remission or at time of subsequent DLI

Arm/Group Title	Multiple DLI - Complete Responders	Single DLI - Complete Responders
Arm/Group Description:	Duration of time patients who achieved a complete remission by day +100 after DLI maintained that remission	Duration of time patients who achieved a complete remission by day +100 after DLI maintained that remission
Overall Number of Participants Analyzed	8	6
Median (Full Range); Unit of Measure: months
	10.1; (1.7 to 12)	9; (1.0 to 12)

3. Secondary Outcome

Title	Acute Graft-versus-host Disease
Description	development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria
Time Frame	100 days post DLI

Outcome Measure Data

Analysis Population Description

Each accrual is evaluable for acute GVHD grade III-IV

Arm/Group Title	Multiple DLI	Single DLI
Arm/Group Description:	Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions	accruals where the patient received only one donor lymphocyte infusion
Overall Number of Participants Analyzed	17	22
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	4 18.2%

Adverse Events

Time Frame	All cause mortality includes individual participants who experienced death due to any cause before 3 years after first DLI and is the only SAE/AE captured per protocol
Adverse Event Reporting Description	All cause mortality includes individual participants who experienced death due to any cause before 3 years after first DLI
Arm/Group Title	Multiple DLI		Single DLI
Arm/Group Description	Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions		accruals where the patient received only one donor lymphocyte infusion
All-Cause Mortality
	Multiple DLI		Single DLI
	Affected / at Risk (%)		Affected / at Risk (%)
Total	10/15 (66.67%)		7/12 (58.33%)
Serious Adverse Events
	Multiple DLI		Single DLI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/15 (66.67%)		7/12 (58.33%)
General disorders
All cause mortality by 3 years after first DLI †	10/15 (66.67%)	10	7/12 (58.33%)	7
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Multiple DLI		Single DLI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0.00%)		0/12 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Theresa Hahn
• Organization: Roswell Park Cancer Institute
• Phone: 716-845-2300
• EMail: theresa.hahn@roswellpark.org

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT00534118
• Other Study ID Numbers: CDR0000564827; RPCI-I-00703
• First Submitted: September 20, 2007
• First Posted: September 24, 2007
• Results First Submitted: July 29, 2020
• Results First Posted: August 26, 2020
• Last Update Posted: August 26, 2020