Phase II Study of Campath-1H Antibody to Treat Waldenstro... | NCT00142181

Studies
Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia

NCT00142181

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

Dec 21, 2012Estimated

Enrollment

27Actual

Phase

Phase 2

Conditions

Lymphoplasmacytic Lymphoma
Waldenstrom's Macroglobulinemia

Interventions

Campath-1H

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Oct 2005Actual

Completion Date

Jun 2008Actual

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 1, 2005

First Posted Date

Sep 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2012

Last Update Posted Date

Dec 21, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Steven P. Treon, MD, PhD, Principal Investigator, Dana-Farber Cancer InstitutePrincipal Investigator

Lead Sponsor

Dana-Farber Cancer InstituteOTHER

Collaborators

Name	Class
Brigham and Women's Hospital	OTHER
Beth Israel Deaconess Medical Center	OTHER
Massachusetts General Hospital	OTHER
Bayer

Description Module

Brief Summary

The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma.

Detailed Description

Patients will receive 3 test doses of Campath-1H (3mg, 10mg, 30mg). If the patient tolerates these three test doses, then they will receive a total of 6 weeks of Campath-1H therapy three times a week.
After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose they will be re-assessed by blood testing. If it is determined that their disease has progressed in the period of time while the patient was on Campath-1H, the patient will be removed from the study.
If it is determined that the patient has achieved a complete remission after 6 weeks of Campath-1H treatment a bone marrow biopsy will be performed to confirm complete remission and the patient will not receive any additional treatment but will be followed for a period of 2 years.
If the disease has remained stable or partial response has been achieved the patient will enter the second phase of therapy in which they will receive an additional 6 weeks of Campath-1H therapy. The patient will then be reassessed as described above.
No additional therapy (as part of this study) will be performed after a 12 week course of Campath-1H.
While the patient is on Campath-1H blood test will be performed at 3-6 month intervals over a period extending for 2 years following the last treatment. Bone marrow biopsies and/or aspirations will be conducted as necessary.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Campath-1H	Experimental	30 mg IV three times a week, 6-12 weeks.	Drug: Campath-1H

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Campath-1H	Drug	Participant will receive three test doses of Campath-1H (3, 10, and 30mg). If this is tolerated then they will receive Campath-IH three times a week for 6 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.		2 years

Secondary Outcomes

Measure	Description	Time Frame
To determine the safety of Campath-1H.		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's macroglobulinemia
Adequate organ function: ANC > 500/ul; PLT > 25,000/ul; serum creatinine < 2.5; serum total bilirubin and SGOT < 2.5 times the upper normal limit.
Age greater than 18 years
Life expectancy of 6 months or greater
ECOG performance status of 0-2

Exclusion Criteria:

Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry.
Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry.
Pregnant women
Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven P. Treon, MD, MA, PhD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Isreal Deaconness Medical Center		Boston	Massachusetts	02115	United States
Dana-farber Cancer Insitiute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21566092	Result	Treon SP, Soumerai JD, Hunter ZR, Patterson CJ, Ioakimidis L, Kahl B, Boxer M. Long-term follow-up of symptomatic patients with lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia treated with the anti-CD52 monoclonal antibody alemtuzumab. Blood. 2011 Jul 14;118(2):276-81. doi: 10.1182/blood-2011-02-338558. Epub 2011 May 12.

ID	Term
D018442	Lymphoma, B-Cell, Marginal Zone
D008258	Waldenstrom Macroglobulinemia

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins