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Trial record 18 of 202 for:    "Leukemia" | "Sargramostim"

Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00014560
Recruitment Status : Terminated (Medarex (supplier of BsAb) stopped study due to toxicities experienced at other sites on unrelated trials halting manufacturing of BsAb)
First Posted : July 30, 2003
Results First Posted : August 5, 2013
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Interventions Biological: bispecific antibody 4G7xH22
Biological: sargramostim
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm
Hide Arm/Group Description This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
Period Title: Overall Study
Started 3
Completed 0
Not Completed 3
Arm/Group Title Single Arm
Hide Arm/Group Description This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Clinical Toxicity
Hide Description This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
Time Frame day 1-29
Hide Outcome Measure Data
Hide Analysis Population Description
This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
Arm/Group Title Single Arm
Hide Arm/Group Description:
This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of BsAb 4G7 x 22
Hide Description This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
Time Frame Day 1-29
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Serum Markers of Macrophage Activation
Hide Description This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
Time Frame Day 1 Hours 0,2,4,6,24, day 15 Hours 0,2,4,6,24
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
Hide Arm/Group Description This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Arm
Affected / at Risk (%)
Total   0/3 (0.00%) 
This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Pamela Ely
Organization: Dartmouth Hitchcock
Phone: 603-653-9071
Layout table for additonal information
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00014560     History of Changes
Other Study ID Numbers: CDR0000068556
P30CA023108 ( U.S. NIH Grant/Contract )
DMS-9806
NCI-G01-1936
First Submitted: April 10, 2001
First Posted: July 30, 2003
Results First Submitted: April 2, 2013
Results First Posted: August 5, 2013
Last Update Posted: May 3, 2018